Conservative Management Following Closed Reduction of Traumatic Anterior Dislocation of The Shoulder (Review)

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Conservative management following closed reduction of traumatic
anterior dislocation of the shoulder (Review)
Braun C, McRobert CJ
Braun C, McRobert CJ.
Conservative management following closed reduction of traumatic anterior dislocation of the shoulder.
Cochrane Database of Systematic Reviews 2019, Issue 5. Art. No.: CD004962.
DOI: 10.1002/14651858.CD004962.pub4.
www.cochranelibrary.com

Conservative management following closed reduction of traumatic anterior dislocation of the shoulder (Review)
Copyright © 2019 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cochrane Trusted evidence.
Informed decisions.

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TABLE OF CONTENTS
HEADER......................................................................................................................................................................................................... 1
ABSTRACT..................................................................................................................................................................................................... 1
PLAIN LANGUAGE SUMMARY....................................................................................................................................................................... 2
SUMMARY OF FINDINGS.............................................................................................................................................................................. 4
BACKGROUND.............................................................................................................................................................................................. 7
OBJECTIVES.................................................................................................................................................................................................. 8
METHODS..................................................................................................................................................................................................... 8
RESULTS........................................................................................................................................................................................................ 11
Figure 1.................................................................................................................................................................................................. 12
Figure 2.................................................................................................................................................................................................. 16
Figure 3.................................................................................................................................................................................................. 17
Figure 4.................................................................................................................................................................................................. 20
DISCUSSION.................................................................................................................................................................................................. 22
AUTHORS' CONCLUSIONS........................................................................................................................................................................... 26
ACKNOWLEDGEMENTS................................................................................................................................................................................ 26
REFERENCES................................................................................................................................................................................................ 27
CHARACTERISTICS OF STUDIES.................................................................................................................................................................. 32
DATA AND ANALYSES.................................................................................................................................................................................... 58
Analysis 1.1. Comparison 1 Immobilisation in external versus internal rotation, Outcome 1 Re-dislocation at ≥ 12 months follow- 60
up (nearest to 24 months accepted)....................................................................................................................................................
Analysis 1.2. Comparison 1 Immobilisation in external versus internal rotation, Outcome 2 Re-dislocation data at last follow- 60
up...........................................................................................................................................................................................................
Analysis 1.3. Comparison 1 Immobilisation in external versus internal rotation, Outcome 3 Re-dislocation, interim follow-ups 60
(3 and 12 months).................................................................................................................................................................................
Analysis 1.4. Comparison 1 Immobilisation in external versus internal rotation, Outcome 4 Re-dislocation: stratified according 61
to external rotation with / without abduction....................................................................................................................................
Analysis 1.5. Comparison 1 Immobilisation in external versus internal rotation, Outcome 5 Validated patient-reported outcome 61
measures for shoulder disability (OSI, WOSI).....................................................................................................................................
Analysis 1.6. Comparison 1 Immobilisation in external versus internal rotation, Outcome 6 Validated PROMS: non-parametric 61
results.....................................................................................................................................................................................................
Analysis 1.7. Comparison 1 Immobilisation in external versus internal rotation, Outcome 7 Resumption of pre-injury activities.... 62
Analysis 1.8. Comparison 1 Immobilisation in external versus internal rotation, Outcome 8 Any instability (subluxation or 62
subjective instability, individually or grouped into composite outcome).........................................................................................
Analysis 1.9. Comparison 1 Immobilisation in external versus internal rotation, Outcome 9 Adverse events................................ 62
Analysis 1.10. Comparison 1 Immobilisation in external versus internal rotation, Outcome 10 Adherence to treatment.............. 63
Analysis 1.11. Comparison 1 Immobilisation in external versus internal rotation, Outcome 11 Subsequent surgery.................... 63
ADDITIONAL TABLES.................................................................................................................................................................................... 64
APPENDICES................................................................................................................................................................................................. 67
WHAT'S NEW................................................................................................................................................................................................. 69
HISTORY........................................................................................................................................................................................................ 70
CONTRIBUTIONS OF AUTHORS................................................................................................................................................................... 71
DECLARATIONS OF INTEREST..................................................................................................................................................................... 71
SOURCES OF SUPPORT............................................................................................................................................................................... 71
DIFFERENCES BETWEEN PROTOCOL AND REVIEW.................................................................................................................................... 71
INDEX TERMS............................................................................................................................................................................................... 72
Conservative management following closed reduction of traumatic anterior dislocation of the shoulder (Review) i
Informed decisions.

[Intervention Review]
Conservative management following closed reduction of traumatic

anterior dislocation of the shoulder
Cordula Braun1, Cliona J McRobert2
1Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center - University of Freiburg, Freiburg, Germany.
2School of Health Sciences, Institute of Clinical Sciences, University of Liverpool, Liverpool, UK
Contact address: Cordula Braun, Institute for Evidence in Medicine (for Cochrane Germany Foundation), Medical Center - University of
Freiburg, Breisacher Str. 153, Freiburg, 79110, Germany. braun@ifem.uni-freiburg.de, cordula_braun@gmx.de.
Editorial group: Cochrane Bone, Joint and Muscle Trauma Group

Publication status and date: New search for studies and content updated (conclusions changed), published in Issue 5, 2019.
Citation: Braun C, McRobert CJ. Conservative management following closed reduction of traumatic anterior dislocation of the shoulder.
Cochrane Database of Systematic Reviews 2019, Issue 5. Art. No.: CD004962. DOI: 10.1002/14651858.CD004962.pub4.
ABSTRACT
Background
Acute anterior shoulder dislocation, which is the most common type of dislocation, usually results from an injury. Subsequently, the
shoulder is less stable and is more susceptible to re-dislocation or recurrent instability (e.g. subluxation), especially in active young adults.
After closed reduction, most of these injuries are treated with immobilisation of the injured arm in a sling or brace for a few weeks, followed
by exercises. This is an update of a Cochrane Review first published in 2006 and last updated in 2014.
Objectives
To assess the effects (benefits and harms) of conservative interventions after closed reduction of traumatic anterior dislocation of the
shoulder. These might include immobilisation, rehabilitative interventions or both.
Search methods
We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials,
MEDLINE, Embase, CINAHL, PEDro and trial registries. We also searched conference proceedings and reference lists of included studies.
Date of last search: May 2018.
Selection criteria
We included randomised or quasi-randomised controlled trials comparing conservative interventions with no treatment, a different
intervention or a variant of the intervention (e.g. a different duration) for treating people after closed reduction of a primary traumatic
anterior shoulder dislocation. Inclusion was regardless of age, sex or mechanism of injury. Primary outcomes were re-dislocation, patient-
reported shoulder instability measures and return to pre-injury activities. Secondary outcomes included participant satisfaction, health-
related quality of life, any instability and adverse events.
Data collection and analysis

Both review authors independently selected studies, assessed risk of bias and extracted data. We contacted study authors for additional
information. We pooled results of comparable groups of studies. We assessed risk of bias with the Cochrane 'Risk of bias' tool and the
quality of the evidence with the GRADE approach.
Main results
We included seven trials (six randomised controlled trials and one quasi-randomised controlled trial) with 704 participants; three of
these trials (234 participants) are new to this update. The mean age across the trials was 29 years (range 12 to 90 years), and 82% of
Conservative management following closed reduction of traumatic anterior dislocation of the shoulder (Review) 1
Informed decisions.

the participants were male. All trials compared immobilisation in external rotation (with or without an additional abduction component)
versus internal rotation (the traditional method) following closed reduction. No trial evaluated any other interventions or comparisons,
such as rehabilitation. All trials provided data for a follow-up of one year or longer; the commonest length was two years or longer.
All trials were at some risk of bias, commonly performance and detection biases given the lack of blinding. Two trials were at high risk of
selection bias and some trials were affected by attrition bias for some outcomes. We rated the certainty of the evidence as very low for
all outcomes.
We are uncertain whether immobilisation in external rotation makes a difference to the risk of re-dislocation after 12 months' or longer
follow-up compared with immobilisation in internal rotation (55/245 versus 73/243; risk ratio (RR) 0.67, 95% confidence interval (CI) 0.38 to
1.19; 488 participants; 6 studies; I2 = 61%; very low certainty evidence). In a moderate-risk population with an illustrative risk of 312 per 1000
people experiencing a dislocation in the internal rotation group, this equates to 103 fewer (95% CI 194 fewer to 60 more) re-dislocations
after immobilisation in external rotation. Thus this result covers the possibility of a benefit for each intervention.
Individually, the four studies (380 participants) reporting on validated patient-reported outcome measures for shoulder instability at a
minimum of 12 months' follow-up found no evidence of a clinically important difference between the two interventions.
We are uncertain of the relative effects of the two methods of immobilisation on resumption of pre-injury activities or sports. One study
(169 participants) found no evidence of a difference between interventions in the return to pre-injury activity of the affected arm. Two
studies (135 participants) found greater return to sports in the external rotation group in a subgroup of participants who had sustained
their injury during sports activities.
None of the trials reported on participant satisfaction or health-related quality of life.
We are uncertain whether there is a difference between the two interventions in the number of participants experiencing instability, defined
as either re-dislocation or subluxation (RR 0.84, 95% CI 0.62 to 1.14; 395 participants, 3 studies; very low certainty evidence).
Data on adverse events were collected only in an ad hoc way in the seven studies. Reported "transient and resolved adverse events" were
nine cases of shoulder stiffness or rigidity in the external rotation group and two cases of axillary rash in the internal rotation group. There
were three "important" adverse events: hyperaesthesia and moderate hand pain; eighth cervical dermatome paraesthesia; and major
movement restriction between 6 and 12 months. It was unclear to what extent these three events could be attributed to the treatment.
Authors' conclusions
The available evidence from randomised trials is limited to that comparing immobilisation in external versus internal rotation. Overall, the
evidence is insufficient to draw firm conclusions about whether immobilisation in external rotation confers any benefit over immobilisation
in internal rotation.
Considering that there are several unpublished and ongoing trials evaluating immobilisation in external versus internal rotation, the
main priority for research on this question consists of the publication of completed trials and the completion and publication of ongoing
trials. Meanwhile, evaluation of other interventions, including rehabilitation, is warranted. There is a need for sufficiently large, good-
quality, well-reported randomised controlled trials with long-term follow-up. Future research should aim to determine the optimal
immobilisation duration, precise indications for immobilisation, optimal rehabilitation interventions, and the acceptability of these
different interventions.
PLAIN LANGUAGE SUMMARY
Non-surgical management after non-surgical repositioning of traumatic anterior dislocation of the shoulder
Background
Acute anterior shoulder dislocation is an injury in which the top end of the upper arm bone is pushed out of the joint socket in a forward
direction. Afterwards, the shoulder is less stable, and prone to either partial or complete re-dislocation, especially in active young adults.
Initial treatment involves putting the joint back in place. This is called ‘closed reduction’ when it is done without surgery. Subsequent
treatment is often conservative (non-surgical) and usually involves a period of immobilisation of the injured arm in a sling or brace, followed
by exercises.
Review question
What are the benefits and harms of different conservative interventions for treating people after closed reduction of a primary traumatic
anterior shoulder dislocation?
This is an update of a review that was first published in 2006 and last updated in 2014. We reviewed the evidence from clinical studies
comparing any conservative intervention (e.g. immobilisation, rehabilitation) versus no treatment or a different intervention, or comparing
different variants of an intervention (e.g. different duration). The primary outcomes of interest were re-dislocation, patient-reported
Informed decisions.

shoulder instability measures (usually questionnaires) and return to pre-injury activities. Further outcomes of interest included patients’
satisfaction with the intervention, health-related quality of life and adverse events.
Search date
We conducted the searches of healthcare literature for this review in May 2018.
Study characteristics
We identified three new relevant studies in this update. In total, this review now includes seven studies with 704 participants. Most of the
participants (82%) were male; the average age across the studies was 29 years (range 12 to 90 years). All of the studies investigated just
one comparison: immobilisation in external rotation (when the arm is orientated outwards with the forearm away from the chest) versus
immobilisation in internal rotation (the usual sling position, where the arm rests against the chest) following closed reduction. Participants
were followed over different lengths of time; the most common duration was two years or longer.
Key results
We are uncertain whether immobilisation in external rotation makes a difference to the risk of re-dislocation at one-year or more follow-
up compared with immobilisation in internal rotation.
None of the four studies reporting on patient-reported outcome measures for shoulder instability at a minimum of one-year follow-up
found evidence of any important difference between the two interventions.
We are uncertain of the relative effects of the two methods of immobilisation on resumption of pre-injury activities or sports. One study
found no evidence of a difference between interventions in the return to pre-injury activity of the affected arm. Two other studies found
greater return to sports in the external rotation group in a small group of participants who had sustained their injury during sports activities.
None of the trials reported on participant satisfaction or health-related quality of life. We are uncertain whether there is a difference
between the two interventions in the number of participants experiencing instability, defined as either re-dislocation or subluxation (a
partial dislocation).
The reporting of adverse events (complications) was unsatisfactory. There were reports of nine cases of short-term shoulder stiffness in
the external rotation group and two cases of under-arm rash in the internal fixation group. There were three more serious adverse events:
abnormal sensitivity and hand pain; abnormal sensation such as tingling in the little finger and along to the elbow; and major movement
restriction. It was unclear to what extent these three adverse events could be attributed to the treatment.
Certainty of the evidence
We rated the certainty of the evidence as very low for all outcomes. This was mainly because there were not enough data and we were
unsure how reliable the results were from the individual studies. Thus we are uncertain about the estimates of effect.
Conclusions
Overall, the current evidence is insufficient to inform the choice of immobilisation in external versus internal rotation. There is no evidence
to inform on any other conservative interventions following closed reduction of traumatic anterior dislocation of the shoulder.
SUMMARY OF FINDINGS

Summary of findings for the main comparison. Immobilisation in external rotation versus immobilisation in internal rotation following closed
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reduction of traumatic anterior dislocation of the shoulder
Immobilisation in external rotation versus immobilisation in internal rotation following closed reduction of traumatic anterior dislocation of the shoulder
Patient or population: patients undergoing conservative management after closed reduction of traumatic anterior dislocation of the shoulder
Setting: splints or slings applied in emergency departments or clinics
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Trusted evidence.
Intervention: immobilisation of arm in external rotation
Comparison: immobilisation of arm in internal rotation
Outcomes Anticipated absolute effects* Relative ef- No. of partic- Certainty of Comments
(95% CI) fect ipants the evidence
(95% CI) (studies) (GRADE)
Assumed risk Correspond-
ing risk
Immobilisa- Immobilisa-
tion in inter- tion in exter-
nal rotation nal rotation
Re-dislocation Low riska RR 0.67 488 ⊕⊝⊝⊝

Follow-up: at 12 (0.38 to 1.19) (6 RCTs) VERY LOWd,e
months or longer 248 per 1000 167 per 1000
(95 to 296)
Moderate riskb
312 per 1000 209 per 1000

(119 to 372)

High riskc
417 per 1000 280 per 1000

(159 to 497)
Validated pa- See com- See com- - 380 ⊕⊝⊝⊝ 3 of the 4 trials reported no or little difference in scores. 1 tri-
tient-reported out- ments ments (4 RCTs) VERY LOWe,g al (97 participants) reported a difference favouring external
come measures for rotation in the WOSI scoref: MD −43.20, 95% CI −72.38; −14.02.
shoulder disabilityf This, however, is unlikely to be clinically important.
Follow-up more
than 24 months
4

Resumption of pre- See com- See com- - 347 ⊕⊝⊝⊝ 1 study (169 participants) found no evidence of a difference
injury activities ments ments (3 RCTs) VERY LOWe,h between interventions in the return to pre-injury activity of
the affected arm (RR 1.02, 95% CI 0.80 to 1.29).
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2 studies (178 participants) reported on return to sports for
the subgroup of participants who had been sports active;
both results were in favour of external rotation.
Participant satis- See com- See com- - - - Outcome not reported

faction with the in- ments ments
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Trusted evidence.
tervention
Quality of life See com- See com- - - - Outcome not reported

ments ments
Any instability: re- 419 per 1000i 352 per 1000 RR 0.84 395 ⊕⊝⊝⊝ 2 other studies (135 participants) provided very low certain-
dislocation or sub- (260 to 478) (0.62 to 1.14) (3 RCTs) VERY LOWe,j ty evidence on instability defined as re-dislocation and/or a
luxation, compos- positive apprehension test. Although favouring external fixa-
ite outcome tion (RR 0.28, 95% CI 0.14 to 0.57), we judged the evidence at
Follow-up at 12 very low certaintyk (downgraded for risk of bias, imprecision
months or longer and indirectness reflecting the suboptimal nature of this out-
come).
Adverse events See com- See com- - 645 ⊕⊝⊝⊝ Adverse events were mostly not prespecified as an outcome,
ments ments (7 RCTs) VERY LOWl i.e. reported ad hoc. We split these into 'transient and re-
solved adverse events' and 'important' (serious) adverse
events. In the first category, there were 9 cases of shoulder
stiffness or rigidity in the external rotation group versus 2
cases of axillary rash in the internal fixation group.
There were 3 'important' adverse events: hyperaesthesia

and moderate hand pain; eighth cervical dermatome paraes-
thesia; and major movement restriction between 6 and 12
months. It was not clear to what extent the adverse events

could be attributed to the treatment.
*The risk in the intervention group (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; MD: mean difference; RR: risk ratio; WOSI: Western Ontario Shoulder Instability Index
GRADE Working Group grades of evidence

High certainty: We are very confident that the true effect lies close to that of the estimate of the effect
Moderate certainty: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is
substantially different
Low certainty: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect
5

Very low certainty: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect
a Assumed low risk based on the lowest control group (internal rotation group) risk out of the 6 contributing studies
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b Assumed moderate risk based on the median control risk of the 6 contributing studies
c Assumed high risk based on the highest control group risk out of the 6 contributing studies
d Downgraded by 1 level for risk of bias (mainly performance, detection and selection biases), 1 level for inconsistency (substantial heterogeneity: I2 = 61%, Chi2 = 0.002) and 1
level for imprecision (low number of events, CI overlapping no effect)
e Publication bias was graded as undetected for all outcomes. We identified 5 studies evaluating immobilisation in external versus internal rotation that have been completed
but that have yet not been published. While this suggests a risk of publication bias, we judged that the information available to us was insufficient for downgrading
Better health.
Informed decisions.
Trusted evidence.
f 3 trials reported results based on the WOSI (range from 0 (least disability) to 2100 (worst disability)). 1 trial used the OSI (range from 0 (worst impairment) to 48 (least impairment))
g Downgraded by 1 level for risk of bias (mainly performance, detection and selection biases), 1 level for inconsistency (marked unexplainable difference of the effect of 1 study to
that of the other studies) and 1 level for imprecision (low number of participants; 3 of the 4 studies found either no or only a small effect that was either reportedly non-significant
or had a CI including overlapping no effect)
h Downgraded by 1 level for risk of bias (mainly performance, detection, selection biases), 1 level for inconsistency (difference in effect of the 3 studies ranging from a large effect
favouring immobilisation in external rotation to no effect) and 1 level for imprecision (low number of outcome events; CIs of 3 of the 4 estimates overlapping no effect)
i Assumed risk based on the median control risk of the 3 contributing studies
j Downgraded by 2 levels for risk of bias (mainly performance, detection, selection and attrition biases) and 1 level for imprecision (low number of events; CIs for 2 of the 3
estimates overlapping no effect)
k Downgraded by 2 levels for risk of bias (mainly performance, detection, selection and attrition biases), 1 level for imprecision (very low number of events) and 1 level for
indirectness (suboptimal outcome measure)
l Downgraded by 2 levels for risk of bias (mainly performance, detection, selection and attrition biases), 1 level for imprecision (very low number of outcome events and small
study sample sizes; no CIs were reported) and 1 level for indirectness (poor definition and reporting of most adverse events)


6

Informed decisions.

BACKGROUND factors for recurrent instability after a primary traumatic anterior

shoulder dislocation. The risk of recurrent instability was reported
Description of the condition to be 3.18 times (95% CI 1.28 to 7.89) more likely in males than
females in Olds 2015; and 2.68 times (95% CI 1.66 to 4.31) more
Dislocation of the shoulder occurs when the head of the humerus
likely in males in Wasserstein 2016. Olds 2015 found people aged 40
(the top of the upper arm bone that forms the ball of the shoulder
years or under were 13.46 times (95% CI 5.25 to 34.49) more likely
joint) is displaced out of the glenohumeral (shoulder) joint. The
to suffer recurrent instability than those older than 40 years. In
extent of dislocation varies from subluxation (partial dislocation) to
Wasserstein 2016, people under 40 years were 20 times (95% CI 10.0
full dislocation (where the joint surfaces completely lose contact).
to 33.3) more likely to suffer recurrent instability than those who
It is usually diagnosed by a combination of history, physical
were 40 or over. Conversely, people with a concomitant fracture of
examination findings and imaging — most often radiography
the greater humeral tuberosity were found to be 7.69 times (95% CI
(x-ray), but more rarely some other imaging modality such as
3.33 to 16.67) less likely to have a recurrent instability in Olds 2015;
magnetic resonance imaging (MRI). The direction of dislocation
and 3.85 times (95% CI 3.33 to 10.00) less likely in Wasserstein 2016.
varies, but in most primary (first-time) dislocations, the head of the
There was poorer quality and often inconsistent evidence for other
humerus is displaced anteriorly (forwards) in relation to the glenoid
factors across the studies in the reviews and also across the two
fossa (the socket of the shoulder joint). The cause is usually trauma,
reviews.
typically during contact sports in adolescents and younger adults.
In older adults, dislocation may result from a fall from standing Description of the intervention
height.
Traditionally, a non-surgical (conservative) approach, comprising
The nature and extent of damage to the soft tissue surrounding closed reduction, three to six weeks' immobilisation in a sling
the shoulder joint from a traumatic anterior dislocation vary, and (i.e. in internal rotation) and a subsequent physiotherapy or
may involve bony, cartilaginous, ligamentous as well as tendinous physical therapy programme has been used for first time
or muscular structures (Demehri 2017; Forsythe 2015). Common dislocations (O'Brien 1987). However, we note recent trends to
presentations include the Bankart lesion, characterised by damage earlier mobilisation and thus a shorter duration of immobilisation
to the anteroinferior part of the glenoid labrum (the fibrocartilage (e.g. Berendes 2015). Moreover, a period of up to one week of
rim that deepens the joint socket) and the capsule surrounding the immobilisation is proposed in a recent British (BESS/BOA) patient
joint (Bankart 1938); and the Hill-Sachs lesion, which involves a care pathway, which refers to evidence suggesting that the risk
compression fracture of the humeral head, as well as damage to its of re-dislocation is not decreased with longer immobilisation (e.g.
overlying cartilage (Hill 1940). Paterson 2010).
Estimates of the incidence of traumatic anterior shoulder Regarding the immobilisation position, recent years have seen
dislocation vary across the literature. A recent epidemiological much interest in an alternative to the traditional (internal rotation)
overview of estimates of the incidence of shoulder dislocation in immobilisation method, whereby the shoulder is immobilised in
various countries reported incidences per 100,000 person years of external (outward) rotation using a custom-made (Itoi 2003) or
12.3 cases in Denmark, 23.1 cases in Canada, 23.9 cases in the USA, commercially manufactured (Sullivan 2007) brace. The interest in
27.5 cases in Sweden and 56.3 cases in Norway (Cameron 2017). immobilisation of the arm in external rotation traces back to work
Cameron 2017 reported the incidence is highest during the second by Itoi and colleagues (Itoi 1999; Itoi 2001; Itoi 2003; Itoi 2007),
and third decade of life, with a peak in the late teens and early who found that the separation of the labrum from the glenoid (as
twenties, and that it decreases with increasing age. Furthermore, present with a Bankart lesion) was significantly reduced when the
the incidence is higher in males and in athletes. The proportion shoulder was positioned in external rotation compared with the
of males was 71.8% in a large US-based epidemiological study traditional internal rotation (sling) position. Itoi postulated that this
including a total of 8940 shoulder dislocations (Zacchilli 2010). may enhance the healing of the Bankart lesion and reduce the risk
of recurrent instability. He later suggested that the addition of an
Once dislocation has occurred, the shoulder is less stable and is abduction component may further improve outcomes (Itoi 2015).
more susceptible to re-dislocation. Estimates of the rate of re- Limited published data are available on the use of immobilisation
dislocation vary considerably across the literature. Two recent in external rotation in clinical practice. However, the findings of
systematic reviews, with different inclusion criteria and numbers two published surveys, conducted among orthopaedic surgeons
of studies, of prognostic studies investigating risk factors in people in the Netherlands and Germany (Berendes 2015 and Balke
after conservative management of a traumatic first-time anterior 2016 respectively), indicate considerable variability. Berendes 2015
shoulder dislocation reported an overall proportion of recurrent found that only 3% of the participating surgeons immobilised
instability (re-dislocation or recurrent subluxation) of 39% (range the shoulder in external rotation, whereas 97% immobilised it in
4% to 74%) after a minimum follow-up of one year (Olds 2015); and internal rotation. Balke 2016 found that 15% of the participating
of 21% (range 19% to 88%) after a minimum follow-up of two years surgeons always immobilised the shoulder in external rotation,
(in Wasserstein 2016). Olds 2015 reported proportions of recurrent whereas 46% did not use this position at all and 39% advised on
instability of 51% in people aged 15 to 20 years; 36% in people aged immobilisation in external or internal rotation individually.
21 to 40 years; 11% in people aged 41 to 60 years; and 10% in people
aged 61 or older. Re-dislocation mainly occurs within the first year; Physiotherapy or rehabilitation, typically started after the
Wasserstein 2016 reported a mean (SD) of 10.8 (0.42) months for the immobilisation period, usually entails advice, education and
first episode. an exercise-based regimen (typically addressing stability,
coordination and strength of the shoulder, shoulder girdle, upper
Both Olds 2015 and Wasserstein 2016 found sex, age and spinal muscles, or combinations of these) aimed at restoring
concomitant fractures of the greater tuberosity to be key prognostic
Informed decisions.

normal shoulder function. This may be supplemented by manual aspects of immobilisation (including the timing of application and
therapy, soft tissue mobilisations and physical modalities. duration, position and whether any immobilisation is better than
none at all, and rehabilitation (its general effectiveness, its relative
Surgical intervention has generally been reserved for cases of effectiveness across different settings and the relative effectiveness
chronic recurrence or instability. However, a Cochrane Review of different packages and modes of delivery) and motion-limiting
(Handoll 2004; updated in 2009) comparing surgical with non- braces. These considerations illustrated the need for an updated
surgical treatment found some limited evidence supporting review.
primary surgery for young adults, usually male, engaged in highly
demanding physical activities who have sustained their first acute OBJECTIVES
traumatic shoulder dislocation.
To assess the effects (benefits and harms) of conservative
Our review considers the various approaches to post-reduction interventions after closed reduction of traumatic anterior
conservative treatment, such as the duration and position of sling dislocation of the shoulder. These might include immobilisation,
immobilisation, the modalities used, and the timing and extent of rehabilitative interventions or both.
physiotherapy and rehabilitation interventions.
METHODS
How the intervention might work
Criteria for considering studies for this review
The aim of treatment for anterior dislocation is to restore a
functional, painless and stable shoulder. The choice of treatment Types of studies
approach will be influenced by patient age and previous history
We considered any randomised or quasi-randomised controlled
of dislocation, occupation, level of activity, general health and
trials (the allocation of the latter by, for example, hospital record
ligamentous laxity and by expectations of patient adherence to a
number or date of birth) evaluating conservative treatment after
prescribed therapeutic regimen.
anterior dislocation of the shoulder.
The aim of immobilisation is to allow healing. In this connection,
Types of participants
some MRI and cadaveric studies of Bankart lesions have shown
better and firmer repositioning of the peeled-away capsule Individuals who have undergone closed reduction for traumatic
when the shoulder is externally rotated than when it is anterior dislocation of the shoulder. Ideally, the acute anterior
internally (inwardly) rotated — the position naturally imposed shoulder dislocation should have been confirmed by physical
by a sling (Dymond 2011; Itoi 2001; Kitamura 2005; Liavaag examination and radiography or another imaging modality such
2009; Miller 2004; Moxon 2010; Pennekamp 2006; Seybold 2009; as MRI. We intended to consider the potential for misdiagnosis,
Siegler 2010). This has kindled and sustained interest in the such as a missed proximal humeral fracture, in trials in which the
possibility that immobilisation in external rotation may improve method of diagnosis was unspecified or in which diagnosis was
healing, and consequently outcomes, in comparison with the based on physical examination alone. We included trials including
traditional approach. However any immobilisation has potential participants with concomitant injuries that are often associated
disadvantages, and there is an argument for shortening its duration with anterior shoulder dislocation, such as a fracture of the greater
(Paterson 2010) or forgoing it altogether (Hovelius 2008) to allow tuberosity of the humerus or a Bankart lesion, as long as treatment
early restoration of movement, especially in the middle-aged to focused on the dislocation rather than on the concomitant injury.
elderly, who are susceptible to stiffness and frozen shoulder as a
result of immobilisation (Robinson 2012) but are less prone to re- Although we stated that we would include individuals of any age,
dislocation than the young (Wasserstein 2016). we correctly anticipated finding no trials focused specifically on the
management of traumatic anterior dislocation in children.
Finally, various exercise interventions might theoretically increase
functional stability by restoring proprioception (spatial awareness) We excluded trials focusing on the treatment of participants with
in the shoulder joint and by retraining muscles to help maintain non-traumatic or habitual dislocations, or concomitant fractures
joint congruency (Karatsolis 2006); while motion-limiting braces such as proximal humeral fractures involving the surgical neck,
might prevent re-dislocation by restricting shoulder movement in or multiple trauma; and those focusing on management of
vulnerable directions (Murray 2013). neurovascular complications or postsurgical management. We
stipulated that trials with mixed populations involving any one
Why it is important to do this review indication of the above would be considered for inclusion if the
proportion of the latter (e.g. atraumatic dislocation) was clearly
This is an update of a Cochrane Review last updated in 2014
defined for each treatment group and was clearly small (< 10%),
(Hanchard 2014); this included only four trials, all of which
or if separate data for acute traumatic anterior dislocation were
compared the immobilisation positions of external and internal
provided.
rotation. It concluded that "the evidence is insufficient to
demonstrate whether immobilisation in external rotation confers Types of interventions
any benefit over immobilisation in internal rotation". Moreover,
Hanchard 2014 pointed to a number of unpublished and ongoing We planned the following.
trials that could inform this comparison, and to the continuing need
1. To assess whether a difference exists between outcomes
for evidence to inform other aspects of conservative management
of different methods (including arm position) and
for this injury. Since then, further trials evaluating immobilisation
durations (including none or intermittent) of postreduction
in external versus internal rotation have been published and there
immobilisation. However, we planned to exclude trials
are also several registered studies. Questions still surround other
Informed decisions.

comparing variants (e.g. duration, position) or supplements intervention provided by a health professional other than the
to particular immobilisation techniques unless the general treating medical doctor, i.e. typically by a physiotherapist,
effectiveness of the method had been established. and typically including supervised exercises with or without
2. To assess whether a difference exists between outcomes adjunctive passive modalities.
of the provision of rehabilitation intervention (of any kind)
versus no intervention. Examples of rehabilitation interventions Types of outcome measures
include advice and education, active and passive mobilisation, We sought the following outcome measures.
proprioception and stabilisation exercises, scapular setting and
trunk stability exercises. These may be used in combination or Primary outcomes
individually and may be applied in various ways and settings.
1. Re-dislocation: separation of the joint requiring reduction and,
Although these interventions are potentially available to all
ideally, verified.
patients allocated the rehabilitation intervention, their actual
application may vary according to the perceived needs of 2. Validated patient-reported outcome measures (PROMs) for
individual patients. We aimed to assess this separately for the shoulder instability (e.g. Oxford Shoulder Instability Score
provision of any rehabilitation (a) during immobilisation, and (b) (Dawson 1999), Western Ontario Shoulder Instability Index
after immobilisation. (WOSI) (Kirkley 1998)).
3. To assess whether a difference exists between outcomes of 3. Resumption of pre-injury activities (work, sport, recreational
different types of rehabilitation interventions. Comparisons activities) (yes or no).
would have included different single modalities or different Secondary outcomes
combinations of rehabilitation modalities. However, we
planned to exclude trials comparing different techniques, timing 1. Participant satisfaction with the intervention
(duration, frequency) and intensity of single rehabilitation 2. Validated health-related quality of life outcome measures
modalities until the effectiveness of the modality itself had (e.g. EQ-5D (standardised measure of health outcome), Short
been established. We also would have excluded trials evaluating Form-36 (SF-36)).
pharmacological interventions and trials testing interventions 3. Any instability: subluxation (separation of the joint not requiring
aimed solely at pain relief. reduction) or subjective instability, either individually or
4. To assess whether a difference exists between outcomes of grouped with dislocation as a composite outcome.
different methods of delivering/providing various rehabilitation 4. Important adverse events (not including re-dislocation or
interventions. Comparisons would have included supervised instability) that were plausibly attributable to post-reduction
therapy versus home exercises, different methods of supervised management (e.g. persistent pain, frozen shoulder). Other
therapy (e.g. individual versus group instruction) and adverse events were to be reported narratively.
differences in the frequency and duration of rehabilitation. In
the first instance, we did not plan to include comparisons of In addition, we intended to take note of any reports of service
rehabilitation intervention delivered by individual professionals utilisation or resource use, for instance length of hospital
(e.g. doctors, physiotherapists, occupational therapists) with stay, outpatient attendance and the provision and nature of
different levels or backgrounds of expertise or training. physiotherapy; and participants' adherence to their allocated
interventions.
For this review update we selected the following four key
comparisons that we considered to reflect priority questions. We excluded studies that did not report on patient-relevant clinical
outcomes but instead reported solely on non-clinical outcomes
1. Arm position during immobilisation: immobilisation in external (e.g. radiological outcomes) as their link with clinical outcomes is
rotation versus immobilisation in internal rotation (comparison largely unclear; i.e. not sufficiently established.
already established in Hanchard 2014).
2. Use and duration of immobilisation: no or limited-duration Timing of outcome measurement
immobilisation (≤ 1 week) versus ‘standard’ duration (typically Approximately one-third of re-dislocations occur within three
3 weeks) (comparison proposed in Hanchard 2014). The months of the initial dislocation, and a further third between three
underlying rationale for the comparison is likely to vary and 12 months (Rhee 2009). We therefore proposed organising
according to the participant group and extent of injury. Thus, outcomes into the following time frames, with greatest importance
we considered other comparisons of duration depending on the attached to long-term reporting.
underlying rationale.
3. Provision of formal rehabilitation, typically post immobilisation: 1. Short-term: up to and including three months following
no formal rehabilitation (e.g. advice, education, home exercise dislocation
sheet only) versus formal rehabilitation. We defined ‘formal 2. Medium-term: greater than three months and up to and
rehabilitation’ as a therapeutic intervention typically provided including 12 months following dislocation
by a health professional (e.g. a physiotherapist) other than the 3. Long-term: greater than 12 months following dislocation
treating medical doctor, that typically includes demonstration
and provision of supervised home exercises with or without Search methods for identification of studies
adjunctive passive modalities over a certain period of time.
Electronic searches
4. Preferable timing of provision of formal rehabilitation: during
and following immobilisation versus following immobilisation We searched the Cochrane Bone, Joint and Muscle Trauma Group
only. We defined 'formal rehabilitation' as a therapeutic Specialised Register (May 2018), the Cochrane Central Register of
Informed decisions.

Controlled Trials (CENTRAL; 2018, Issue 4) in the Cochrane Library objective outcomes (e.g. re-dislocation) and subjective outcomes
(searched 21 May 2018), MEDLINE including Ovid MEDLINE(R) Epub (e.g. PROMs) separately in our assessment of blinding of outcome
Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid assessment and completeness of outcome data. However, we
MEDLINE(R) Daily and Ovid MEDLINE and Versions(R) (1946 to 16 changed this approach and assessed these two domains separately
May 2018), Embase (1974 to 2018 Week 21), CINAHL (1982 to 21 for each reported outcome instead.
May 2018), PEDro (Physiotherapy Evidence Database) (1929 to May
2018) and OTseeker (Occupational Therapy Systematic Evaluation Measures of treatment effect
of Evidence Database) (inception to November 2012). We also When available and appropriate, we present quantitative data for
searched the WHO International Clinical Trials Registry Platform outcomes listed in the inclusion criteria graphically. We calculated
(22 May 2018), ClinicalTrials.gov (22 May 2018) and the UK National risk ratios (RRs) and 95% confidence intervals (CIs) for dichotomous
Research Register (2005, Issue 3, now archived) for ongoing and outcomes. We calculated mean differences (MDs) and 95% CIs for
recently completed trials. For this update, the searches were continuous outcomes.
limited to 2013 onwards. We applied no language restrictions.
Unit of analysis issues
In MEDLINE (Ovid Web), the subject-specific strategy was combined
with the sensitivity-maximising version of the Cochrane Highly We were alert to the remote possibility of unit of analysis issues
Sensitive Search Strategy for identifying randomised trials, and this in the included studies but in the event we identified none. One
was modified for use in other databases (Lefebvre 2011). Search participant in Chan 2018 was included twice: they experienced
strategies for CENTRAL, MEDLINE, Embase, CINAHL and PEDro two shoulder dislocations, one in each shoulder, at an interval of
can be found in Appendix 1. Details of the search strategies used three years (additional information provided by contact author).
previously are published in Hanchard 2014 and Handoll 2006. We considered the potential impact of this single case on the results
was negligible.
Searching other resources
Dealing with missing data
We checked reference lists of articles. We searched the conference
proceedings of the British Elbow and Shoulder Society (BESS), We approached study authors for missing data by email. If we
published in Shoulder & Elbow (2013 to 2017). We handsearched requested answers to more than a few questions, we provided a pro
conference proceedings published in Orthopaedic Proceedings, a forma to ensure clarity and to minimise the burden on trial authors.
supplement to The Bone and Joint Journal (January 2013 to May We did not impute missing data.
2018). We also checked the lists of ongoing studies and studies
awaiting classification in Hanchard 2014 for any publications of Assessment of heterogeneity
these studies. We tested heterogeneity between comparable trials using a
standard Chi2 test; this we considered statistically significant at
Data collection and analysis a P value of less than 0.1. When we noted some indication
Selection of studies of heterogeneity, from visual inspection of the results or based
on results of the Chi2 test, we also quantified heterogeneity/
Both review authors (CB, CMR) independently assessed potentially inconsistency using the I2 statistic (Higgins 2003). We interpreted
eligible trials for inclusion; we resolved all disagreements through this as follows, according to guidance in Section 9.5.2, Higgins 2011.
discussion. Titles of journals, names of authors and names of
supporting institutions were not masked at any stage. 1. 0% to 40%: might not be important
2. 30% to 60%: may represent moderate heterogeneity
Data extraction and management
3. 50% to 90%: may represent substantial heterogeneity
Both review authors independently extracted data. We piloted 4. 75% to 100%: represents considerable heterogeneity
the date-extraction form on an excluded study. We resolved any
disagreement through discussion. Assessment of reporting biases
Assessment of risk of bias in included studies If a meta-analysis of a key outcome had included more than 10
studies, we would have considered exploring the potential for
We assessed risk of bias independently, without masking the publication bias by generating a funnel plot. We considered the
source and authorship of trial reports. We piloted the assessment presence and number of completed but yet unpublished trials
form on one trial. Between-rater consistency in assessment was as an additional potential source of publication bias, but judged
checked by one review author (CB) at data entry; and we resolved that the available information was too limited to allow for a clear
all disagreements by discussion. We used the Cochrane 'Risk of judgement.
bias' tool (Higgins 2011): this tool incorporates assessment of
randomisation (sequence generation and allocation concealment), Data synthesis
blinding (of participants and of treatment providers), blinding of
Where appropriate, we pooled results of comparable studies using
outcome assessment, completeness of outcome data, selection of
both fixed-effect and random-effects models. We decided the
outcomes reported and other sources of bias. Among these other
choice of the model by careful consideration of the extent of
sources we considered discrepancies in the level of skill or care
heterogeneity and whether it could be explained, in addition to
with which compared interventions were applied (performance
other factors, such as the number and size of included studies. We
bias) and commercial sponsorship (because of the potential for
used 95% CIs throughout. We considered not pooling data where
reporting bias). In this update, in line with the stated intention
there was considerable heterogeneity (I2 statistic value ≥ 75%) that
in Hanchard 2014, we initially intended to assess risk of bias for
Informed decisions.

could not be explained by the diversity of methodological or clinical 2011). We used the GRADE approach following guidance from the
features among trials. Where it was inappropriate to pool data, we Cochrane Handbook for Systematic Reviews of Interventions (Higgins
present trial data in the analyses or tables for illustrative purposes 2011). However, as the outcome data for most outcomes could only
and report these in the text. be pooled to a very limited extent, we further considered recent
guidance on the application of the approach to evidence when data
Subgroup analysis and investigation of heterogeneity have been summarised narratively rather than by meta-analysis
We proposed, where possible, to undertake subgroup analyses (Murad 2017).
by sex, as males are at much greater risk of re-dislocation (Olds
2015; Wasserstein 2016). We also proposed to subgroup by age,
RESULTS
using two thresholds: 20 years or younger versus 21 years or older;
Description of studies
and 39 years or younger versus 40 years or older. We chose the
former threshold because patients aged 21 years or younger are Results of the search
at much greater risk of re-dislocation (Wasserstein 2016), and the
We carried out searches were carried out in May 2018 and covered
latter because of the markedly increased susceptibility of patients
the period between September 2013 and May 2018 (see Appendix
older than 40 years to post-immobilisation stiffness and secondary
1). We screened a total of 918 records from the following databases:
frozen shoulder (Robinson 2012). We further proposed to subgroup
Cochrane Bone, Joint and Muscle Trauma Group Specialised
by presence (versus absence) of a concomitant fracture of the
Register (1); CENTRAL (155), MEDLINE (146), Embase (275), CINAHL
greater tuberosity of the humerus, as there is evidence of an
(221), PEDro (18), the WHO ICTRP (53) and ClinicalTrials.gov (49). We
association between the presence of a greater tuberosity fracture
further found three potentially eligible studies from other sources
and a decreased risk of instability or recurrent re-dislocation (Olds
(one through the searches for conference proceedings, one through
2015; Wasserstein 2016); or of presence (versus absence) of another
handsearching for further information on an ongoing trial and one
specific lesion resulting from the dislocation (e.g. a Bankart lesion).
incidentally through a different search).
However, there were insufficient data to conduct most of these
subgroup analyses. After removing duplicates, we reduced 918 records to 665. We
examined the titles and abstracts of these records and discarded
We also planned but did not carry out separate outcome analyses 650, leaving a total of 15 new records (including trial registrations)
of (1) participants who were physically active compared with to examine in more detail. Where possible, we obtained full-text
those who were more sedentary; (2) physically active young copies of these potentially relevant records.
adults engaged in highly demanding physical activities who have
sustained primary anterior dislocation compared with others; and We attempted to contact the investigators of the unpublished
(3) participants with a primary dislocation compared with those trials, either listed as ongoing or awaiting classification in
with a recurrent dislocation. We anticipated that any subgroup Hanchard 2014 or newly identified, for information on their
differences would be in terms of size of effect (quantitative current status (ACTRN12611001183976; ACTRN12616001241426;
interaction) rather than direction of effect (qualitative interaction). Chan 2018 (formerly Kelly 2011); Eshoj 2017; ISRCTN41070054;
ISRCTN48254181; Miller 2007; Murray 2016 (formerly
We also considered conducting an exploratory subgroup analysis of NCT01111500); NCT02197819; NCT00707018). We received
trials in which immobilisation in external rotation had an abduction responses in relation to four studies (ACTRN12611001183976;
component versus those without (external rotation only). ACTRN12616001241426; Chan 2018; Murray 2016).
To test for differences between subgroups, we planned to inspect At this stage, we excluded seven records. We also excluded
the overlap of confidence intervals and to perform the test for one formerly ongoing study that had been abandoned
subgroup differences available in Review Manager 5 software. (ACTRN12611001183976). New reports or information resulted in
the inclusion of three more trials (Chan 2018: formerly Kelly
Sensitivity analysis
2011, a study awaiting classification; Heidari 2014; and Whelan
We intended to perform sensitivity analyses, when appropriate, to 2014: formerly Whelan 2008, a study awaiting classification).
investigate various aspects of trial and review methodology. We Two registered studies (ACTRN12616001241426; NCT02197819),
intended to include, when data were available, examinations of one study reported in a published protocol (Eshoj 2017), and
the effects of (1) removing trials at high risk of selection bias from ARTISAN, a study reported in the UK National Institute for Health
inadequate allocation concealment or at high risk of detection bias Research Health Technology Assessment Database (NIHR-HTA),
from lack of blinded outcome assessment; (2) conducting worst- were added as ongoing studies. One previously ongoing study was
case analyses for trials with missing data; and (3) using fixed-effect moved to studies awaiting classification (Murray 2016, formerly
versus random-effects models for pooling. NCT01111500). We linked any references pertaining to the same
study under a single study ID.
'Summary of findings' table and assessment of the certainty of
the evidence There are now seven included trials (Chan 2018; Finestone
2009; Heidari 2014; Itoi 2007; Liavaag 2011; Taskoparan 2010;
Where data were available, we proposed to produce a 'Summary
Whelan 2014); 17 excluded studies (including nine from the
of findings' table for each of the prespecified priority comparisons
previous searches); five ongoing trials; and six studies awaiting
(see types of interventions) and all primary and secondary
classification.
outcomes. We applied the GRADE approach to assess the certainty
of the evidence related to each of the key outcomes listed in A flow diagram summarising the study selection process for this
the Types of outcome measures (see Section 12.2; Schunemann update is shown in Figure 1.
Informed decisions.


Figure 1. Study flow diagram for this update (2019)
Informed decisions.

Included studies the forearm rested across the abdomen). In Table 1, the key
characteristics of the immobilisation treatment are summarised for
Full details of the individual studies are given in the Characteristics
each trial.
of included studies tables. These also include information about
funding sources and declarations of interests. We attempted to Timing of immobilisation
contact the corresponding authors of the three newly included
trials for additional information on specific aspects including There was some variation in the commencement of immobilisation.
outcome data (Chan 2018; Heidari 2014; Whelan 2014). We received In Liavaag 2011 and Taskoparan 2010 immobilisation commenced
responses from one of the authors of Chan 2018 (Dr Kieran Bentick, on the day of the dislocation; in Itoi 2007 within two days after
personal communication 1 September 2018). We did not receive dislocation; and in Whelan 2014 within five days after dislocation.
responses from the authors of Heidari 2014 and Whelan 2014. Heidari 2014 and Whelan 2014 did not specify when treatment
commenced, but presumably treatment commenced shortly after
Study design the assessment in these trials, which was within six hours after
dislocation in Heidari 2014 and within seven days after dislocation
Of the seven parallel, two-group included clinical trials, six in Whelan 2014.
were RCTs (Chan 2018; Finestone 2009; Heidari 2014; Itoi 2007;
Liavaag 2011; Whelan 2014), and one was a quasi-randomised trial Duration of immobilisation
(Taskoparan 2010).
The duration of immobilisation, whether internal or external
Study setting rotation, was three weeks in Heidari 2014, Itoi 2007, Taskoparan
2010 and Liavaag 2011; and four weeks in Chan 2018, Finestone
The seven trials were conducted in seven different countries. Chan 2009 and Whelan 2014. Participants were mostly instructed to
2018 was conducted in six NHS hospitals across England; Finestone remove their brace or sling only for showering.
2009 in the Accident and Emergency Department of an Israeli
university hospital; Heidari 2014 in the emergency department of a Types or brands of braces and slings
university-affiliated hospital in Iran; Itoi 2007 in 12 hospitals across
The trials used a variety of external rotation braces. Chan 2018,
Japan; Liavaag 2011 in 13 hospital emergency departments in
Liavaag 2011 and Whelan 2014 reported using commercial off-the-
Norway; Taskoparan 2010 in an emergency department in Turkey;
shelf braces and specified the specific brand or manufacturer, or
and Whelan 2014 in three university clinics in Canada.
both. Immobilisation in internal rotation was mostly done with a
Study size traditional sling or sling and swathe bandage.
The trials included 704 participants. Study size ranged from 33 Position of immobilisation
participants in Taskoparan 2010 to 198 in Itoi 2007. Of note: Chan The degree of external rotation used varied from 0° to 5° in Whelan
2018 had aimed to recruit 160 participants, but stopped at 72 2014; 10° in Heidari 2014, Itoi 2007 and Taskoparan 2010; 15° in
participants as the trial was discontinued early. Liavaag 2011; 15° to 20° in Finestone 2009; to 30° in Chan 2018. In
two trials, the arm was additionally immobilised in abduction: 30°
Participants
in Chan 2018 and 15° in Heidari 2014.
All participants had experienced a primary traumatic anterior
dislocation of the shoulder reduced by various closed methods. Provision of immobilisation
Regarding the prevalence of concomitant injuries, all but one The providers of the braces and slings, and of the accompanying
of the trials specified 'associated fractures of the shoulder' as instructions, were unclear in four studies (Finestone 2009; Heidari
an exclusion criterion; Taskoparan 2010 did not provide any 2014; Liavaag 2011; Taskoparan 2010). In Chan 2018, the braces
information. Liavaag 2011 and Whelan 2014 specified the type of and slings were provided "by appropriately trained members of
fractures and other injuries, including labral lesions, that were staff" (i.e. usually by surgeons, nurses or healthcare assistants;
excluded (see Characteristics of included studies). None of the trials additional information provided by the contact author); in Itoi
provided information about the prevalence and characteristics of 2007, by the treating surgeons; and in Whelan 2014 by certified
concurrent injuries for their actual study samples. orthopaedic technicians.
Five studies evaluated mixed, general populations, without Post-immobilisation treatment
restrictions of age and sex. In Finestone 2009, all 51 participants
were male, and 40 of these were soldiers. Liavaag 2011 limited In six of the seven included trials, treatment with immobilisation
inclusion to patients aged 16 to 40 years, and Heidari 2014 limited was followed by some form of rehabilitation for both groups.
inclusion to patients aged 15 to 55 years. Of the 704 participants, In Liavaag 2011, there was no mention of rehabilitation. Most
578 (82%) were male. The mean age of the participants across the of the trials provided only limited information about the post-
trials was 29 years: these ranged from 20 years in Finestone 2009 immobilisation treatment, and most did not specify parameters
to 37 years in Itoi 2007. Participant age ranged from 12 to 90 years; such as duration or frequency. Whelan 2014 was alone in reporting
both extremes were reported in Itoi 2007. an overall duration of 16 weeks. Chan 2018 was alone in providing
the physiotherapy protocol for their study as a supplement to
Interventions their report, in which a staged approach to rehabilitation was
outlined, which ranged from an initial four-week "quiet time" to
All seven included trials compared post-reduction immobilisation "late rehabilitation" after six weeks. In all trials reporting post-
of the affected arm in external rotation (the arm oriented outwards immobilisation treatment, exercises were the key component.
and the forearm away from the chest) versus immobilisation These were supervised by physiotherapists in four trials (Chan 2018;
in internal rotation (the traditional sling arrangement, with
Informed decisions.

Finestone 2009; Heidari 2014; Whelan 2014), with no information were reported for all pre-specified follow-up time points in all trials,
available for Itoi 2007 and Taskoparan 2010). and some trials reported outcomes across a wide period of time
that extended considerably beyond their last set follow-up time.
Outcomes Notably, Taskoparan 2010 provided a table that listed the results
Primary outcomes of individual participants at individual follow-ups, ranging from 6
to 41 months and also did not specify when data were collected
Only Itoi 2007 did not report on re-dislocation as a discrete on re-dislocation or on adverse events. For Whelan 2014, results
outcome. It was not always clear how this outcome was assessed are presented for "minimum 12 months' follow-up", but not for the
and confirmed in the other six trials: in two trials, Chan 2018 different follow-up points.
and Heidari 2014, the assessment was either completely or partly
patient-reported; with either no, or no mention of, verification Funding and conflicts of interest
through reference to medical records or further evaluation.
Five trials reported their sources of funding (Chan 2018; Finestone
Four studies reported on one or more validated patient-reported 2009; Heidari 2014; Itoi 2007; Whelan 2014); one stated that no
outcome measures for shoulder instability. Three trials used the funding was received (Liavaag 2011); and one did not provide any
Western Ontario Shoulder Instability Index (WOSI) (Heidari 2014; information about funding (Taskoparan 2010).
Liavaag 2011 ; Whelan 2014) and Chan 2018 used the Oxford
Shoulder Instability Index (OSI). None of the trials explicitly declared any conflicts of interest. Six
studies declared that there were no or at least no financial conflicts
Three studies reported on return to pre-injury sport or activities of interest while Taskoparan 2010 did not provide any information
(Heidari 2014; Itoi 2007; Liavaag 2011). about conflicts of interest.
Secondary outcomes Further details about the funding and conflicts of interest are given
in the Characteristics of included studies table.
None of the included studies reported on participant satisfaction
or on generic health-related quality of life measures (e.g. EQ-5D or Excluded studies
SF-36).
Fifteen of the 17 excluded studies or articles were excluded mainly
Any instability, including subluxation or subjective instability, as the result of insufficient information and lack of response
either individually or grouped with dislocation as a composite from study authors (Harper 2000; Kiviluoto 1980; Staply 2002;
outcome, was reported in several ways. Itoi 2007 and Liavaag Wakefield 2001) or failure to meet our selection criteria (Blanchard
2011 prespecified re-dislocation or subluxation as a composite 2015; Chutkan 2012; Hovelius 1983; Hutchinson 2013; Itoi 2015;
outcome; Liavaag 2011 also prespecified subluxation as a stand- Königshausen 2014; Lacy 2015; McCarty 2014; Momenzadeh 2015;
alone outcome. Whelan 2014 prespecified 'recurrent instability' Whelan 2010; Xu 2003). Momenzadeh 2015 was excluded because
as the primary outcome; results were reported separately for it did not include any of the pre-specified outcomes of interest for
'recurrent dislocation', 'recurrent instability' (recurrent dislocation this review; this study focused exclusively on radiological outcomes
or subluxation) and 'recurrent instability requiring surgical at three weeks.
stabilization'. Both Heidari 2014 and Taskoparan 2010 reported the
rate of patients with a positive apprehension test. As reported in Hanchard 2014, the relationship between Itoi 2003,
which was reported as a preliminary study, and Itoi 2007 was
Although adverse events were mentioned in all of the reports, the unclear. Furthermore, in light of contradictory information received
trials did not appear to have a priori strategies for defining or from the trial investigator, we could not rule out the possibility that
collecting these data. there were trial participants in common; therefore we excluded Itoi
2003.
Other outcomes
Finally, we excluded one previously ongoing study after the
Adherence was the only other outcome collected by the included
principal investigator informed us that the trial had been
studies. Definitions and measurements of adherence varied across
abandoned (ACTRN12611001183976).
the six trials reporting this outcome.
Further details of these studies are given in the Characteristics of
We made the post-hoc decision to document two further outcomes
excluded studies tables.
with the 'other outcomes', because we considered these as of
potential interest both to clinicians and researchers: 'difficulties Studies awaiting classification
with wearing the braces or slings' and 'surgery'. Although these
outcomes may arguably be viewed as 'adverse events', we Six RCTs await classification; see Characteristics of studies awaiting
considered it more appropriate to document them separately. Chan classification. Five are parallel, two-group RCTs comparing
2018 provided a detailed account of difficulties with wearing the immobilisation in external rotation versus immobilisation in
braces and slings. Four studies reported the rate of patients who internal rotation (ISRCTN41070054; ISRCTN48254181; Miller 2007;
underwent surgery during the study period (Chan 2018; Finestone Murray 2016; NCT00707018). We have identified no published full
2009; Heidari 2014; Liavaag 2011) . reports related to any of these, and our efforts to contact the
corresponding authors for information about the current status
Follow-up time points of their study and the actual or anticipated availability of a
Follow-ups were conducted at various time points, and were mostly published full report were mostly unsuccessful. ISRCTN41070054
defined as post-dislocation (Table 2). However, not all outcomes (with an initial target sample size of 50, revised down to 38),
ISRCTN48254181 with a target sample size of 150 and NCT00707018
Informed decisions.

with a target sample size of 50 are all completed, according to last update posted August 2017); the estimated primary study
the WHO International Clinical Trials Registry Platform; and long completion date is specified as February 2018. Our attempts to
intervals have passed since the respective anticipated or actual end obtain more information on these two trials were unsuccessful.
dates (between 2008 and 2012). Miller 2007 and Murray 2016 are Outcomes of these two studies included re-dislocation.
published abstracts, but neither provides sufficient information to
stand alone. Miller 2007 reported interim results for 30 participants, The three other ongoing studies compare different aspects of
but the total sample aimed for or achieved is unknown. Murray rehabilitation after shoulder dislocation (ACTRN12616001241426;
2016 reported results for 50 participants. Dr Murray informed us ARTISAN; Eshoj 2017). Recruitment of a target sample
that publication of this trial is pending (personal communication, of 48 participants has been delayed until 2019 for
31 May 2018). ACTRN12616001241426, which is intended to test a purpose-
designed smartphone application (including information and an
Outcomes of these five studies include re-dislocation at exercise-based rehabilitation programme) as an adjunct to a
two years (Murray 2016) or at unspecified time points supervised rehabilitation programme provided to all participants.
(ISRCTN41070054; ISRCTN48254181); patient-reported outcome The ARTISAN trial is a multicentre, NIHR-funded study with a target
measures for shoulder instability at one year (Miller 2007; sample size of 478 participants. It aims to compare two different
NCT00707018); time taken to resume pre-injury sport or other rehabilitation strategies starting after two weeks of immobilisation:
activities (NCT00707018); and any instability at two years a single session of "advice to aid self-management" versus
(NCT00707018). the same session followed by a course of individually tailored
physiotherapy over four months. Eshoj 2017, which has a published
Also still awaiting classification is Itoi 2013. This parallel, three- protocol, compared a 12-week specific neuromuscular exercise
group RCT, which was already included as a study awaiting programme (the 'SINEX' programme) versus 12 weeks of 'standard
classification in Hanchard 2014, is published as a full report, care'; i.e. a self-managed shoulder exercise programme with
but compares supplements to a yet unproven method (treatment a single introductory supervised physiotherapy session in 56
with or without a shoulder motion restriction band following patients. According to the trial registration record (NCT02371928),
immobilisation in external rotation). As such, this trial is still not data collection for this study was completed in June 2017. We were
eligible for inclusion at this time. unsuccessful in our attempt to obtain information on the current
status of this study. The primary outcome measures of these three
Ongoing studies
studies are the OSI (ACTRN12616001241426; ARTISAN 2018) and the
All five ongoing studies are parallel, two-group RCTs; see WOSI (Eshoj 2017).
Characteristics of ongoing studies. Of these, two compare
immobilisation in external rotation versus immobilisation in Risk of bias in included studies
internal rotation (NCT01648335; NCT02197819). The recruitment Risk of bias for the seven domains varied across the included
status of NCT01648335, with an unspecified target sample size, is studies and across outcomes (see Figure 2; Figure 3). All studies
'unknown' (ClinicalTrials.gov, last update posted in March 2013). were at some, either high or unclear, risk for one or more outcomes,
NCT02197819, with a target sample size of 75, is still recruiting and we judged none to be at low risk.
according to the registration record (accessed at ClinicalTrials.gov;

Informed decisions.

Figure 2. Risk of bias graph: authors' judgements about each risk of bias item presented as percentages across all
included studies

Informed decisions.

Figure 3. Risk of bias summary: authors' judgements about each risk of bias item for each included study
Informed decisions.

Allocation bias (Itoi 2007; Liavaag 2011; Whelan 2014). This is because
subluxation is inevitably subjective and generally much less
We judged three of the seven trials to be at low risk of selection
amenable than re-dislocation to a clear-cut definition. There was
bias (Chan 2018; Finestone 2009; Whelan 2010). We judged two at
no mention of blinding for the two trials assessing instability via
high risk: Itoi 2007, which probably lacked allocation concealment;
a clinician-reported positive anterior apprehension test; hence we
and Taskoparan 2010, as the result of quasi-random sequence
rated the risk of detection bias as unclear for these (Heidari 2014;
generation and lack of allocation concealment. We judged the
Taskoparan 2010).
remaining two trials at unclear risk of selection bias as both
used sealed envelopes but provided insufficient details to confirm Adverse events
allocation concealment (Heidari 2014; Liavaag 2011).
We rated all seven trials at unclear risk of detection bias for this
Blinding outcome given the lack of information to allow a judgement.
Blinding of participants and personnel Incomplete outcome data
Due to the nature of the studied interventions, participants could Re-dislocation
not be blinded. We judged the risk of performance bias as 'high'
for all seven trials. Regarding the blinding of the care providers, We judged the risk of attrition bias for re-dislocation at final follow-
some trials did not provide any information about who applied the up was low for four trials as there were either no or small losses to
braces or slings and gave the initial instructions (Finestone 2009; follow-up (Chan 2018; Finestone 2009; Heidari 2014; Liavaag 2011).
Heidari 2014; Taskoparan 2010); and in two trials it was unclear We judged the risk as unclear for Whelan 2014, where no reason
whether those who applied the braces and slings and gave the was given for the losses to follow-up but these were similar in the
instructions were otherwise independent of the trial (Chan 2018; two groups (13% versus 14%). We rated Taskoparan 2010 at high
Whelan 2014). In Itoi 2007, the participants were instructed by the risk of attrition bias because the flow of participants throughout
treating surgeons, and the authors themselves stated that "we and the study was unclear and there appeared to have been a large
the other surgeons might have made a stronger effort to ensure unexplained (and also unbalanced) number of losses to the 2-year
adherence to the external rotation immobilization". In Liavaag follow-up (63% in the external rotation group and 35.3% in the
2011, participants were informed of the preliminary results of Itoi external rotation group).
2007, which had favoured immobilisation in external rotation.
We judged the risk of bias was high for the interim scheduled follow-
Blinding of outcome assessment ups at 3 and 12 months for Chan 2018 because the losses were
unbalanced between the groups, with high proportions of losses in
Re-dislocation the internal rotation group: 22% versus 8% at 3-month follow-up;
We judged two trials that assessed re-dislocation to be at low risk and 33% versus 14% at 12-month follow-up).
of detection bias because it was confirmed either by reference
Validated patient-reported outcome measures for shoulder
to medical records (Liavaag 2011) or radiography and/or record
instability
of manipulative reduction in a controlled hospital or healthcare
setting (Whelan 2014). We rated another four studies at unclear We rated two of the four trials that assessed this outcome at low
risk of detection bias, reflecting either a lack of information risk of attrition bias because the losses were small (Heidari 2014;
how re-dislocation was assessed and/or verified (Finestone 2009; Liavaag 2011). We judged the risk as unclear for Whelan 2014, for
Taskoparan 2010) or that re-dislocation was (at least partly) patient- the same reasons as above for re-dislocation. We judged Chan 2018
reported, without further verification (Chan 2018; Heidari 2014). at high risk because the losses to follow-up were unbalanced at
We considered that patients' reports of re-dislocation, a distinct both the final 24-month follow-up (31% versus 17%) and 12-month
and clear-cut event, are less vulnerable to subjectivity than other follow-up (33% versus 17%). The reason for all losses to follow-
patient-reported outcomes. up was the inability to contact these participants. No missing data
were replaced.
Validated patient-reported outcome measures for shoulder instability
We judged all four trials that assessed this outcome to be at Resumption of pre-injury activities
high risk of detection bias (Chan 2018; Heidari 2014; Liavaag In two of the three studies who assessed this outcome, the reported
2011; Whelan 2014); the reason being that these patient-reported outcome data related to a subgroup of participants who had
outcome measures are inherently subjective. sustained their injury during sports (Heidari 2014; Itoi 2007). We
judged Heidari 2014 at low risk given the small loss to follow-up
Resumption of pre-injury activities
and, conversely, Itoi 2007 at high risk because of the high loss
We judged all three trials that assessed this outcome at unclear to follow-up. We judged Liavaag 2011 at unclear risk because the
risk of bias (Heidari 2014; Itoi 2007; Liavaag 2011). Although this losses to follow-up were reasonably low and balanced between the
assessment is subjective we considered this outcome, assessed two groups (11% versus 10%).
by a simple statement about whether or not the participants had
resumed pre-injury activities or sports, as less susceptible to bias Any instability
than other subjective outcomes. We judged Heidari 2014 was at low risk of bias for this outcome in
view of the small loss to follow-up; and Liavaag 2011 and Whelan
Any instability
2014 at unclear risk, given the fairly modest loss to follow-up was
We judged the three trials that assessed a composite outcome balanced in the two groups (13% versus 14% in both trials). We
comprising re-dislocation or subluxation at high risk of detection judged the other two trials reporting this outcome at high risk of
Informed decisions.

attrition bias for any instability: in Itoi 2007, this was due to the high interests. Taskoparan 2010 did not provide any information about
and unexplained attrition in both groups (18.3% versus 21.3%); funding and was thus rated at unclear risk of other bias. We judged
and in Taskoparan 2010, there were very considerable unexplained Itoi 2007 at high risk of bias relating to this aspect as they disclosed
losses to follow-up, particularly at two years (62.5% versus 35.5%). potentially substantial disbursements by the manufacturer of their
immobilisers.
Adverse events
Other bias
We judged five trials at unclear risk of attrition bias because of a lack
of information (Chan 2018; Finestone 2009; Heidari 2014; Liavaag Itoi 2007 reported switching from a locally made wire-mesh
2011; Whelan 2014); and two trials at high risk given their high loss splint covered with sponge and stockinette to a commercially
to follow-up (Itoi 2007; Taskoparan 2010). manufactured external rotation prototype brace part way through
the trial. We are unsure whether this change is a source of bias but
Selective reporting unexplained change to protocol is of concern. Hence we rated this
We judged the risk of reporting bias as low in one trial (Liavaag trial at unclear risk of bias for this aspect.
2011), the only study for which a separately published a priori
protocol was available. We judged the risk of reporting bias as
Effects of interventions
unclear in five studies (Chan 2018; Finestone 2009; Heidari 2014; See: Summary of findings for the main comparison
Taskoparan 2010; Whelan 2014), mainly because of insufficient Immobilisation in external rotation versus immobilisation in
information due to lack of a protocol, registration record or other internal rotation following closed reduction of traumatic anterior
publications. Additionally, in Whelan 2014 results were reported dislocation of the shoulder
for a follow-up of "at minimum 12 months" (mean 25, range 12 to
43 months), but not for each of the prespecified follow-up points; All seven trials compared immobilisation of the affected arm in
it is unclear whether this may have introduced reporting bias. We external rotation versus internal rotation. We could not organise
judged Itoi 2007 at high risk of reporting bias because the start point outcomes within our planned framework of short term (up to
and selection criteria varied across the available reports and may and including three months following dislocation), medium term
not have been determined prospectively, with related concerns (greater than three months and up to and including 12 months)
regarding outcome assessment. and long term (longer than 12 months) because the available
data did not allow this. The most common follow-up was '24
Other potential sources of bias months or longer', which is when over 85% of re-dislocations would
As per protocol we considered discrepancies in the level of skill be expected to have occurred (within two years after the initial
or care with which the compared interventions were applied and dislocation; Robinson 2006).
commercial sponsorship (involvement). We also considered if there We undertook some meta-analyses. However, given the limitations
were any other sources of bias that were additional to those of the data, a cautious approach is needed in the interpretation of
assessed in the other domains. We rated the risk of other bias these, which is reflected in our GRADE assessments of either low or
based on whether we judged there was a risk of bias relating to very low certainty.
the individual items. We judged the risk of other bias was low for
five trials (Chan 2018; Finestone 2009; Heidari 2014; Liavaag 2011; There were no or insufficient data to carry out our proposed
Whelan 2014); unclear for Taskoparan 2010; and high for Itoi 2007. subgroup analyses detailed in Subgroup analysis and investigation
of heterogeneity. We present the available data for different age
Discrepancies in the level of skill or care with which the groups for re-dislocation and 'any instability'. Possibilities for
compared interventions were applied sensitivity analyses were also very limited.
Only Whelan 2014 identified the involvement of a certified
orthopaedic technician for application of the interventions. The effects of interventions are reported below; see also Summary
The other trials provided no or minimal information on this of findings for the main comparison.
aspect. Care programmes other than immobilisation and related
Primary outcomes
advice, although mostly poorly described, appeared to have been
comparable for both groups in all trials. Although we were unable Re-dislocation
to assess whether there were different skill levels in the provision
Six of the seven included studies contributed data from 488
of the two interventions, we did not consider any trial was at
participants (69% of the 704 randomised participants) to the
additional risk of performance bias.
results for this outcome; Itoi 2007 reported only on instability as a
Commercial sponsorship composite outcome of re-dislocation or subluxation.
Four trials were at low risk of bias related to commercial interests, There is very low certainty evidence that external rotation may
either by explicit confirmation of receiving no benefits from a make little difference to the risk of re-dislocation after 12 or more
commercial company (Finestone 2009; Heidari 2014; Liavaag 2011) months' follow-up (55/245 versus 73/243; RR 0.67, 95% CI 0.38 to
or an absence of commercial sources among the listed funders 1.19; 488 participants; 6 studies; I2 = 61%; see Analysis 1.1; Figure 4).
(Whelan 2014). In Chan 2018, the external rotation braces were We rated the quality of this evidence as very low after downgrading
provided by the manufacturer. However, the trial report notes that by one level for risk of bias, one level for inconsistency and one
the manufacturer "[was] not involved in the design, data analysis level for imprecision. We provide further data for re-dislocation
or preparation of this data", which we consider indicates that the in Analysis 1.2. The mean proportion of participants with re-
trial was conducted and reported independently of the commercial dislocation across the six trials that investigated this outcome was
Informed decisions.

22% (range 4% to 37%) in the external rotation groups and 30% analysis confirmed the visual impression that Heidari 2014, the only
(range 25% to 42%) in the internal rotation groups. Sensitivity trial that found a statistically significant result in favour of external
analysis shows that the removal of the only quasi-RCT (Taskoparan rotation, was the source of the significant heterogeneity. The results
2010), which was at high risk of selection and attrition biases, after the removal of Heidari 2014 did not show a difference between
resulted in little change to the results (RR 0.73, 95% CI 0.41 to the two groups (53/194 versus 56/192; RR 0.95, 95% CI 0.69 to 1.32;
1.29; 455 participants, I2 = 63%; analysis not shown). Sensitivity 386 participants; I2 = 1%; analysis not shown).

Figure 4. Forest plot of Re-dislocation at ≥ 12 months follow-up (nearest to 24 months accepted)

Chan 2018 provided additional data for prespecified follow-ups of follow-up in Chan 2018 suggest that most dislocations occurred
at three months, when only one participant had experienced a within the first year in this study. Taskoparan 2010 and Whelan 2014
re-dislocation; and 12 months, when there was no evidence of a did not provide any data.
difference between the two groups (RR 0.88, 95% CI 0.37 to 2.10; 55
participants); Analysis 1.3. Validated patient-reported outcome measures for shoulder
instability
Subgroup analyses
Four of the seven included trials contributed data from 380
There were insufficient data to conduct subgroup analyses. participants (54% of 704 randomised participants) to the results
Moreover, consideration was further complicated by the findings for this outcome (Chan 2018; Heidari 2014; Liavaag 2011; Whelan
that the removal of Heidari 2014 alone resolved the finding of 2014). Three trials reported results based on the WOSI; this score,
significant heterogeneity; and moreover resulted in evidence of which comprises 21 items, each of which is scored on a 100 mm
little or no difference between the two groups. Data that could have visual analogue scale, ranges from 0 (least disability) to 2100
contributed to subgroup analysis by age are presented in Table 3; as (worst disability) (Angst 2011; Kirkley 1998). Chan 2018 reported
well as illustrating the insufficiency of the available data, the results results of the OSI; this score, which comprises 12 items (each of
for the 39 years or younger versus 40 years or older category are which has five response options, scoring 0 to 4), ranges from 0
dominated by Heidari 2014. (worst impairment) to 48 (least impairment) (Dawson 1999; van
der Linde 2015). Although Taskoparan 2010 used the Rowe Score,
We considered conducting an exploratory subgroup analysis of another validated instrument for assessing instability, it was not
trials in which immobilisation in external rotation had an abduction clear whether this was patient-assessed. Moreover, the data were
component versus those without (external rotation only). However, not usable since they applied to a large range of follow-up times
as well as there being only a few trials available in each subgroup, (6 to 41 months) and the distribution was very skewed with 22 of
the heterogeneity between the two trials for the external rotation the 33 at the top end (95 or 100) of the scale). We did not pool
with abduction groups was considerable (I2 = 84%); these results the very limited data that were potentially available for pooling
are presented for illustrative purposes only in Analysis 1.4. for this outcome. We rated the certainty of the evidence for this
Time to re-dislocation
outcome as very low after downgrading for risk of bias, imprecision
and inconsistency (each by one level).
The majority of re-dislocations appeared to have occurred within
the first year after the initial dislocation. Heidari 2014 and Itoi Heidari 2014 found lower WOSI scores, indicating less disability, at
2007 reported that most re-dislocations occurred during the first the 33-months follow-up in the external rotation group (MD −43.20,
year after the initial dislocation; however, Itoi 2007 did not provide 95% CI −72.38 to −14.02; 97 participants; Analysis 1.5). Whelan 2014,
separate data for this outcome. In Finestone 2009, the mean time which expressed the WOSI result in % of the total (reversed) score
to re-dislocation was 12.4 months (range 4 to 36 months); and in (0% = worst outcome, 100% = best outcome), found only a minimal
Liavaag 2011, the mean time to re-dislocation was 11.6 months difference between the groups in the WOSI at a mean follow-
(range 2 to 24 months). The data provided for the different lengths up of 25 months: −3.00, 95% CI −12.78 to 6.78; 52 participants;
Informed decisions.

Analysis 1.5). Reporting non-parametric data, Chan 2018 reported 2011; Whelan 2014). In the other two trials, we defined it as
no statistically significant differences between the groups in the OSI a positive apprehension text or re-dislocation (Heidari 2014;
at either 24-month (57 participants) or 12-month (54 participants) Taskoparan 2010). Although we pooled the data for each of these
follow-ups, as did Liavaag 2011 (174 participants) based on WOSI two categories, it was in the knowledge of serious limitations of
results at a mean of 29 months' follow-up; see Analysis 1.6. the available data especially reflecting loss to follow-up in Itoi 2007
(data available for 159 (80%) of 198 participants); Liavaag 2011
None of the trials provided estimates of the minimal important (subluxation data were only available for 163 (89%) of participants
difference (MID) to guide interpretation of results for the OSI or but 'recurrent instability' was reported for 184 participants in the
WOSI. Also, only very limited MID estimates are yet available from trial report); and Taskoparan 2010 (25 (76% of 33) followed up for
the literature. Based on a cohort study of 105 participants with one year).
shoulder instability (primary dislocation or recurrent instability)
and using an anchor-based analysis approach, van der Linde 2017 There is insufficient evidence of little or no between-group
suggested an estimate of around 6 points for the OSI and an difference in the number of participants with instability
estimate of around 14% for the WOSI (which corresponds to 294 (subluxation or re-dislocation, or potentially both): 77/205 versus
points). These estimates provide some preliminary indication that 86/190; RR 0.84, 95% CI 0.62 to 1.14; 395 participants, 3 studies;
the results of the trials, including that for Heidari 2014 where the I2 = 31%; very low certainty evidence downgraded two levels for
larger 95% confidence limit (72.38) was much smaller than the MID very serious risk of bias and one level for imprecision; Analysis 1.8).
of 294 points, for both the OSI and the WOSI are unlikely to be The data for our other measure of instability (positive apprehension
clinically important. or re-dislocation) favoured the external rotation group but were
dominated by the re-dislocation data from Heidari 2014: 8/67
Resumption of pre-injury activities versus 29/68; RR 0.28, 95% CI 0.14 to 0.57; 135 participants,
Three of the seven included trials contributed data from 347 2 studies; I2 = 0%). We rated the certainty of this evidence as
participants (49% of 704 randomised participants) to the results for very low after downgrading by two levels for risk of bias, one
this outcome (Heidari 2014; Itoi 2007; Liavaag 2011). This outcome level for imprecision and one level for indirectness (reflecting the
was poorly defined in each trial, and we considered the information suboptimal measurement of the outcome).
provided was insufficient to justify pooling. We rated the certainty
Itoi 2007 presented subgroup data related to different age groups
of the evidence for this outcome as very low after downgrading for
for recurrent dislocation or reluxation at a follow-up of two years
risk of bias, imprecision and inconsistency (each by one level).
or longer, with categories that were similar to our pre-defined age
The available results are shown in Analysis 1.7. Both Heidari 2014 categories: ≤ 20 years versus ≥ 21 years; ≤ 40 years, ≥ 40. The data
and Itoi 2007 reported the return to sports for the subgroup of are presented in Table 4.
participants who had sustained their initial injury during sport.
Adverse events
Heidari 2014 found a large difference in favour of external rotation
in return to pre-injury sportive activities at 24 months: 26/31 versus With the exception of Chan 2018, trials reported specifically on
12/38; RR 2.66, 95% CI 1.62 to 4.35; 69 participants). Itoi 2007 found adverse events, but usually in an ad hoc and incomplete way.
a greater return in the external rotation group at 24 months to any It was sometimes unclear whether the reported 'adverse events'
level of sport (43/60 versus 31/49, RR 1.13, 95% CI 0.87 to 1.48; 109 were exclusively treatment-related and we found it hard to judge
participants) and to pre-injury sport activity (22/60 versus 10/49; RR whether some events merited being considered 'important'. Thus,
1.80, 95% CI 0.94 to 3.43; 109 participants). However, both 95% CIs for example, Heidari 2014 reported three cases in the external
for Itoi 2007 included the possibility of a result in favour of internal fixation group of "transient shoulder rigidity that resolved by the
rotation. Liavaag 2011 found no difference between the two groups time of the follow-up at 24 months", without giving an indication
in the return to the pre-injury level of activity with the affected arm of the severity, duration or treatment of the shoulder stiffness.
at a mean 29 months' follow-up: 51/83 versus 52/86; RR 1.02, 95% We decided this was probably not an important adverse event
CI 0.80 to 1.29, 169 participants). and pooled this result with data from Itoi 2007 for six cases of
temporary stiffness resolved via the "use of self-directed range-
Secondary outcomes of-motion exercises" and two cases of axillary rash in the internal
Participant satisfaction with the intervention rotation group in Finestone 2009.
No studies considered this outcome. Liavaag 2011 reported two "complications" at unspecified time
points: one participant in the external rotation group had
Validated quality of life outcome measures hyperaesthesia and moderate hand pain, and one in the internal
No studies considered generic health-related quality of life rotation group had eighth cervical dermatome paraesthesia.
outcome data (using e.g. EQ-5D, SF-36). Taskoparan 2010 reported that one participant in the internal
rotation group had "30° limitation in abduction and 10 degrees
Any instability: subluxation or subjective instability (either in internal rotation in the 6th and 12th months. This patient
individually or grouped with dislocation as a composite was 75 years old and had additional rotator cuff problems".
outcome) Taskoparan 2010 did not clarify whether these limitations were
active (as with rotator cuff tear) or active and passive (as with frozen
Five of the seven included trials contributing data from 530 shoulder). We judged the complications from these two trials to be
participants (75% of 704 randomised participants) reported this important adverse events. Whelan 2014 reported there had been no
outcome in two distinct ways. In three trials, the outcome was treatment-related complications.
defined in terms of subluxation or re-dislocation (Itoi 2007; Liavaag
Informed decisions.

These data, stratified by the two categories of severity, are 1 to 4) in the external rotation group and 3.5 (range 3 to 4) in the
presented for illustrative purposes in Analysis 1.9: transient and internal rotation group (nonparametric analysis; reported P = 0.02).
resolved adverse events (9/196 versus 2/181; RR 2.73, 95% CI 0.83
to 9.02; 377 participants, 4 studies; I2 = 56%); important adverse Taskoparan 2010 noted that "all patients adapted quite well to the
events (1/134 versus 2/134; RR 0.61, 95% CI 0.08 to 4.46; 268 fixation methods".
participants, 3 studies; I2 = 0%). We rated the certainty of the
Surgery
evidence for adverse events as very low after downgrading by two
levels for risk of bias, one level for imprecision (very few events) Four trials reported the rates of participants who underwent or
and one level for indirectness reflecting the poor definition and were scheduled for surgery (Chan 2018; Finestone 2009; Itoi 2007;
reporting of adverse events. Whelan 2014). However, only very limited information was provided
regarding the precise indications for surgery, and how the decision
Other outcomes for surgery was arrived at. Pooled data showed evidence of little
We intended to document any reports of service utilisation or or no difference between the two groups (20/172 versus 24/155; RR
resource use (e.g. length of hospital stay), outpatient attendance 0.76, 95% CI 0.44 to 1.30; 327 participants, 4 studies; I2 = 0%; very
and the provision and nature of physiotherapy; and participants' low certainty data downgraded one level for risk of bias and two
adherence to their allocated interventions. Of these, only levels for imprecision; Analysis 1.11).
adherence was addressed in the included studies. We made the
Economic outcomes
post hoc decision to report two further outcomes with the 'other
outcomes', as we considered these data of interest to both clinicians No data on aspects of service utilisation or resource use (e.g. length
and researchers: one was 'difficulties with wearing the braces or of hospital stay), outpatient attendance and the provision and
slings'; the other one 'surgery'. We did not consider these outcomes nature of physiotherapy were reported.
as 'adverse events'.
DISCUSSION
Adherence
Six studies reported on adherence, although using different
Summary of main results
measures and definitions. The data for complete or top-level This updated review of conservative management following closed
adherence to treatment interventions for six trials are shown in reduction of traumatic, anterior shoulder dislocation now includes
Analysis 1.10, with definitions of the measures used in individual seven trials, which recruited 704 participants in total. In line
trials provided in the footnotes. The differences in the measures with previous versions of this review, all trials made just one
used, the significant statistical heterogeneity (I2 = 82%) together comparison: that of immobilisation in external versus internal
with differences in effect direction, meant that we did not pool rotation. The evidence for this comparison is presented in Summary
these data. The extent of 'complete' adherence varied between of findings for the main comparison and summarised below for the
trials, with almost full adherence reported for Finestone 2009; seven outcomes.
indeed the only omitted participant had removed his splint two
days early. In contrast, only 47% of participants of the internal There is very low certainty evidence that there may be little or
fixation group used their splints for at least 16 hours for at least no difference between the two interventions in the numbers of
20 days in Liavaag 2011. As reported above, Itoi 2007 admitted the participants experiencing a re-dislocation at 12 months' or longer
possibility that stronger encouragement to ensure adherence had follow-up. In Summary of findings for the main comparison, we
been given to the external mobilisation group. identify the lowest, median and highest control group rates of re-
dislocation from the included trials to represent illustrative low-,
Difficulties with wearing the braces or slings medium- and high-risk populations and present the anticipated
Chan 2018 alone provided a detailed description of reported absolute effects for these three populations. We illustrate these
difficulties with wearing the braces or slings. Overall, 27 of results here for a moderate risk population: based on an illustrative
34 participants (79%) in the external rotation group reported risk of 312 people experiencing a dislocation in the internal rotation
difficulties compared with 13 (46%) of 28 participants in the group, the pooled results from six studies (RR 0.67, 95% CI 0.38
internal rotation group. The majority of the participants (21/34 to 1.19) equates to 103 fewer (95% CI 194 fewer to 60 more) re-
(62%)) in the external rotation group complained about difficulties dislocations after immobilisation in external rotation.
with wearing their braces during the night. Reasons included There is no evidence of a clinically relevant difference between the
pain, difficulties with sleeping and loosening of straps. Other two interventions in validated patient-reported outcome measures
complaints included "feeling that the brace did not support the for shoulder instability. Individually, the four studies reporting
arm (21%), functionally awkward in the daytime (18%), difficulty in on validated patient-reported outcome measures for shoulder
application of the sling (15%) and pain when in external rotation instability at a minimum of 12 months' follow-up found no evidence
(12%)". In the conventional sling group, reported difficulties with of a clinically important difference between the two interventions
wearing the slings included "night symptoms (25%), difficulty (very low certainty evidence).
in application/loosening of the straps (14%), feeling hot/itchy
(11%) and pain around the neck strap (7%)". The "level of We are uncertain of the relative effects of the two methods of
comfort", which was assessed on a 4-point ordinal scale (1 = immobilisation on resumption of pre-injury activities or sports. One
very uncomfortable; 2 = moderately uncomfortable; 3 = slightly study (169 participants) found no evidence of a difference between
uncomfortable; 4 = comfortable), was reported as significantly interventions in the return to pre-injury activity of the affected
higher in the conventional sling group; the median was 3.0 (range arm (very low certainty evidence). Two studies (135 participants)
found greater return to sports in the external rotation group but this
Informed decisions.

finding was limited to subgroups of participants who had sustained This should also be considered in the context of unpublished
their injury during sports activities (very low certainty evidence). evidence. There are five completed studies that tested the same
comparison, that are awaiting assessment and that may have
No data were available for participant satisfaction with the recruited 318 participants (ISRCTN41070054; ISRCTN48254181;
intervention or for validated health-related quality of life outcome Miller 2007; Murray 2016; NCT00707018). Furthermore, there
measures (e.g. EQ-5D and SF-36). are two ongoing studies, one of which aims to recruit 75
participants (NCT02197819); the status of the other trial is unknown
There is no evidence of a difference between the two interventions
(NCT01648335). Thus the evidence for this comparison is far from
in the number of participants experiencing instability, defined as
being complete.
either re-dislocation of subluxation (very low certainty evidence).
Applicability
There was very low certainty evidence available for adverse events,
which were reported on an ad hoc basis in the seven trials. Population
Reported 'transient and resolved adverse events' were nine cases
All participants had experienced a traumatic anterior dislocation
of shoulder stiffness or rigidity in the external rotation group and
of the shoulder that had been reduced by a closed method. All
two cases of axillary rash in the internal fixation group. There were
studies except Taskoparan 2010 explicitly excluded patients with
three 'important' adverse events: hyperaesthesia and moderate
associated fractures of the shoulder, and two studies also excluded
hand pain; eighth cervical dermatome paraesthesia; and major
patients with specific labral injuries (Liavaag 2011; Whelan 2014).
movement restriction between 6 and 12 months. It was unclear to
However, as none of the trials specified the prevalence and/or
what extent these three adverse events could be attributed to the
characteristics of concurrent injuries within their actual samples,
treatment.
the applicability of the findings to patients with, or without, or with
The main results of this updated review confirm the results of the different types of concomitant injuries is unclear.
previous version by Hanchard 2014, and are twofold. Firstly, robust
The evidence from the included studies represents the young and
evidence for superiority of immobilisation in external rotation
active as well as the relatively sedentary. Four studies evaluated
over immobilisation in internal rotation is still lacking, which
mixed, general populations, with no restrictions on sex or age (Chan
implies that there is no justification for recommending any change
2018; Finestone 2009; Itoi 2007; Whelan 2014). In contrast, all 51
in current clinical practice. Secondly, we found no includable
participants were male of which 40 were soldiers in Finestone 2009.
evidence related to our other objectives.
The greater proportion of males (82% of 704) in the studies is
Overall completeness and applicability of evidence consistent with the epidemiology for this injury. Although there was
insufficient information on the distribution of ages, an assessment
The available evidence from clinical trials on conservative of the mean ages and inclusion criteria of the seven studies suggests
management after closed reduction of traumatic primary anterior that the majority of participants were above 20 years and below 40
shoulder dislocation as yet relates exclusively to the comparison years old. These indicate that review findings are applicable to the
of immobilisation in external versus internal rotation. None of the majority of people who sustain this injury.
included studies compared different durations of immobilisation
or immobilisation versus no immobilisation. The latter may Interventions
be of particular interest for older people who are at a much The evidence included in this review relates exclusively to the
reduced risk of recurrence (Olds 2015; Wasserstein 2016) — but comparison of immobilisation in external versus internal rotation.
at greater risk of shoulder stiffness (de Boer 2005). Furthermore, Some aspects of these interventions, such as the duration of
none of the included studies addressed interventions following immobilisation (3 or 4 weeks), were similar across the trials.
immobilisation, including comparisons of rehabilitation versus However, given recent trends to promote immobilisation for
no rehabilitation or of different variants of rehabilitation. The shorter periods, such as up to a week (see Background), the longer
lack of evidence on post-immobilisation interventions is a duration used in the included studies may not reflect current
remarkable finding considering that immobilisation represents practice or trends. Other aspects differed to some extent across
only the initial short-term treatment post dislocation. However, the studies, such as the commencement of the immobilisation
we identified three ongoing trials that were designed to (ranging from within a couple of hours until seven days post injury)
compare different aspects of rehabilitation after traumatic and the position of immobilisation in external rotation (which
primary shoulder dislocation, with target sample sizes of 48 ranged from 0° to 5° external rotation in Whelan 2010 to 30° in
(ACTRN12616001241426), 80 (Eshoj 2017) and 478 (Kearney 2018). Chan 2018; and was complemented by an abduction component
This finding may indicate a timely shift of the focus of interest in Chan 2018 and Heidari 2014 (30° and 15°, respectively)). It is
from initial treatment (with immobilisation) to other interventions unclear whether these differences could have affected estimates
(following initial immobilisation). of effects and the applicability of the results. However, the fact
that the precise position of the shoulder was mostly neither
Overall completeness
accurately measured nor monitored, and that the position is
Our search for this update led to the inclusion of only three likely to have varied to some extent through the handling of the
new studies, so the current body of evidence consists of seven braces by the participants, tends to minimise the differences. The
studies including 704 participants that compared immobilisation different external rotation angles appeared to be mostly justified
in external versus internal rotation. Pooled data for the main by a trade-off between findings from previous clinical trials or
outcomes were available from 488 participants (69% of 704) for re- studies investigating structural aspects and the (documented or
dislocation and 395 (56% of 704) for any instability. No data are anticipated) tolerability of maximum external rotation angles. Our
available for patient satisfaction or quality of life. exploratory subgroup analysis of data for re-dislocation related
Informed decisions.

to external rotation with versus without an abduction component determine the type and frequency of adverse events associated
does not allow for any firm conclusions. It was not clear who with immobilisation in external and internal rotation.
provided the braces and slings as well as the accompanying
instructions in four studies (Finestone 2009; Heidari 2014; Liavaag No data on aspects of service utilisation or resource use (e.g. length
2011; Taskoparan 2010). Differences in the level of experience and of hospital stay), outpatient attendance and the provision and
skills may have affected the way the braces and slings were applied, nature of physiotherapy were reported.
as well as the quality of the instructions that the participants
Although patient satisfaction was not reported, adherence
received, and may thereby have affected outcome. Although all
assessed in all seven trials and reported difficulties and complaints
studies reported that the immobilisation period was followed by
relating to brace or sling use measured in Chan 2018 may give
some sort of rehabilitation for both groups, most of the studies
some indirect guide to patient satisfaction during treatment.
provided insufficient information regarding the precise duration,
There may, however, be other factors. The high adherence rate
amount and content of rehabilitation treatment.
in Finestone 2009 may be at least partly due to the fact that
Outcomes and outcome assessment most participants were soldiers who, as the authors state, "had a
high degree of self-discipline and were treated within a military
Although definitions and reports of follow-up periods varied across framework". Itoi 2007 pointed to the possibility that there had
the trials, all trials included participants who were followed up been stronger encouragement to ensure adherence given to the
for at least one year and generally two years (Table 2). Chan external mobilisation group. Liavaag 2011, whose authors also
2018 was the only study reporting data for interim time points (3 found higher adherence in the external rotation group, conjectured
and 12 months). The literature on time to re-dislocation suggests that participants in this group may have had confidence in the
an average time to re-dislocation of around 12 months: a recent benefit of treatment. In contrast, Heidari 2014 reported greater
systematic review by Wasserstein 2016 pooled data from four adherence in the internal rotation group, and itemised in their
studies and reported a mean time of 10.8 months (SD 0.42). discussion additional limitations associated with external rotation,
Regarding the studies included in our review, Finestone 2009 and such as walking safely through doorways, difficulties finding a
Liavaag 2011 reported a mean time of 12.4 (range 4 to 36 months) comfortable sleeping position and risk of trauma in crowded
and 11.6 months (2 to 24 months), respectively. Moreover Heidari locations. Data supporting this was presented in Chan 2018, who
2014 and Itoi 2007 reported that the majority of re-dislocations found a greater proportion of participants in the external rotation
within their study samples occurred within the first year after the group reported difficulties, including with sleeping and feeling
initial dislocation (the rate in Itoi 2007 was 83%). These data show functionally awkward in the daytime. This finding is unsurprising,
that length of follow-up was generally acceptable in the included as intuitively one might expect maintenance of external rotation
trials. Nonetheless, considering that rates of re-dislocation can still at the shoulder during normal day-to-day functioning to be
be expected to vary between follow-ups of one year and two or cumbersome.
more years, assessment at different time points (e.g. one year,
two years) would have been helpful to ensure consistency across We introduced a new secondary outcome — 'subsequent surgery'
studies as well as to facilitate judgements about applicability. — that helps to give a better picture of what happened to some
of the people with recurrent instability. There is no evidence of a
All of our primary outcomes were addressed by at least some of the difference between the two groups.
included studies. However, of our secondary outcomes there were
no data for patient satisfaction or for quality of life using a validated Certainty of the evidence
generic health-related quality of life outcome measure such as EQ-5
We judged the certainty of the evidence included in this review as
or SF-36. Interestingly, the term 'quality of life measure' is also
very low for all outcomes shown in Summary of findings for the
commonly applied for disease specific PROMs, such as the WOSI
main comparison. The grading of the quality of evidence means
and ASES (Heidari 2014; Whelan 2014). These outcome measures,
that we are uncertain about the estimates of effect.
though, are disease-specific and were therefore considered with
the validated PROMs for shoulder instability. We downgraded the certainty of the evidence for all outcomes at
least by one level for risk of bias. In aggregate, concerns about
All studies included some documentation of adverse events;
risk of bias relate, to some extent, to all risk of bias domains, to
however, most did not specify adverse events as an a priori
all outcomes, and to all trials (Figure 2; Figure 3). Notable aspects
outcome, but reported them ad hoc. It was mostly unclear whether
were that we judged two of seven trials at high risk of selection bias
or not the reported events were systematically assessed in all
and, reflecting that blinding to the interventions was not possible
participants, and no definitions were provided. Moreover the
for either the participants or personnel, that all studies were at
information provided was insufficient to judge whether the events
high risk of performance bias. This is demonstrated indirectly in
were, or could be, related to the treatment, or whether they were
Itoi 2007, where the trial authors raised the possibility that stronger
(part of) distinct medical conditions that occurred sometime during
encouragement to ensure adherence had been given to the external
the study periods. This was partly due to a lack of information
mobilisation group. The effect of lack of blinding on the risk of
on when the reported events occurred, but also the severity of
detection bias is likely to be outcome-dependent, as reflected in
the observed events was not sufficiently described. It is notable
our assessments for the different outcomes. The risk of attrition
that all nine cases of short-term shoulder stiffness occurred in the
bias also varied with outcome: the presentation of the amount
external rotation group; the possibility of this complication seems
of losses to follow-up was insufficient and often misleading, even
something that could be considered when treating people with the
when presented in flow diagrams, as they were not specified for
more rigid position used for external immobilisation. The a priori
each outcome. There was a high risk of selective reporting bias in
definition and specification of adverse events, and the systematic
Itoi 2007. The key domains that led to our downgrading for risk
collection of data on adverse events, would have been helpful to
Informed decisions.

of bias by one level were selection bias, performance bias and As previously indicated (see Overall completeness and applicability
detection bias. The key domain that led to our further downgrading of evidence), we recognise the number of studies awaiting
by one level was attrition bias. classification as an unavoidable limitation of the review.
We downgraded the certainty of the evidence for several outcomes Although we did not conduct a formal update of the search
for inconsistency. For re-dislocation, we noted that the substantial after May 2018, we maintained regular checks via Medline
heterogeneity disappeared on the removal of Heidari 2014, which (PubMed) auto-alerts up to December 2018. These yielded Murray
markedly differed from the other studies with regard to the positive 2018, the full-trial report of Murray 2016, another trial that
findings in favour of immobilisation in external rotation for other compared immobilisation in external versus internal rotation;
outcomes. There are insufficient data to explore the underlying see Characteristics of studies awaiting classification). A brief
sources of heterogeneity and, in particular, to identify plausible investigation of the effects of adding the results for re-dislocation
reasons for the more positive findings in favour of external fixation from Murray 2018, which included 50 participants, did not indicate
of Heidari 2014. that its inclusion would lead to an important change to the review
findings. The study will be included in a future update of this review.
We downgraded the certainty of the evidence for all outcomes
for imprecision. This reflected wide 95% CIs, often including the Agreements and disagreements with other studies or
possibility of benefit favouring either one of the interventions to reviews
various degrees, or no effect; as well as too few events and small
sample sizes. We identified five systematic reviews that evaluated clinical
outcomes of conservative care following primary anterior shoulder
Indirectness was graded as not serious for most outcomes except dislocation and that have been published since 2014 (when the
'any instability', which reflects the suboptimal measurement of previous version of this review, Hanchard 2014, was completed)
the outcome; and 'adverse events', which reflects the ad hoc (Kavaja 2018; Liu 2014; Longo 2014; Vavken 2014; Whelan 2016 ).
approach to collecting data on these and suboptimal reporting. Of these, three were limited to the comparison of immobilisation
Overall, however, the trials provided direct evidence to the review in external versus internal rotation (Liu 2014; Vavken 2014; Whelan
question despite some variation in the populations, interventions 2016); whereas Longo 2014 and Kavaja 2018 had a broader scope.
and outcomes. Longo 2014 was designed to compare surgical versus conservative
interventions, but included the comparison of immobilisation in
Publication bias was graded as undetected for all outcomes. We external versus internal rotation after closed reduction. Kavaja 2018
identified five studies evaluating immobilisation in external versus included any interventions for treating patients after a traumatic
internal rotation that have been completed but that have yet not shoulder dislocation or with chronic post-traumatic shoulder
been published. While this is of concern, as it suggests a risk of instability. The reviews differed in the numbers of included studies,
publication bias, we judged that the information available to us was which is mostly attributable to their publication date. None of
insufficient for a clear judgement and thus did not downgrade for the reviews included Chan 2018. Kavaja 2018, the most recently
this item. published review, did not include Taskoparan 2010, the reason
being that quasi-randomised trials were not included in this review.
Potential biases in the review process
The most commonly assessed outcome in the reviews was re-
We strove throughout the development and execution of this
dislocation or recurrence, which was assessed by all. Four of the
updated review to minimise any potential for biases. Thus,
reviews agreed with our findings of no evidence of a difference
when feasible, we adhered throughout to the detailed a priori
in the rate of re-dislocation between immobilisation in external
protocol, which detailed every aspect of the review's aims,
versus internal rotation following closed reduction (Kavaja 2018;
objectives and methods, and documented any changes that
Liu 2014; Vavken 2014; Whelan 2016). All four reviews pooled
we considered necessary in Differences between protocol and
data on re-dislocation or recurrence, with overall similar estimates
review. We conducted a reasonably comprehensive search without
despite some variability in the approaches to meta-analysis. For
language restriction, and involving various sources, and the key
example, some reviews — Liu 2014, Longo 2014 and Vavken 2014
processes of study selection, data extraction and risk of bias
— included data from Itoi 2007 in their meta-analysis, hence
assessment were each independently performed by the two review
synthesizing recurrence (re-dislocation or subluxation) rather than
authors.
re-dislocation alone. In contrast to the findings from our review
We contacted investigators and authors of ongoing studies and the four other reviews, Longo 2014 was alone in reporting
and studies classified as awaiting classification for clarification finding that immobilisation in external rotation resulted in a lower
of questions related to the status of their studies, and rate of re-dislocation compared with internal rotation. This may be
corresponding authors of the included studies for clarification of because Longo 2014 pooled data from just four studies (Finestone
methodological aspects, missing details or data. Unfortunately 2009; Itoi 2003; Itoi 2007; Taskoparan 2010). Of note: we excluded
we were unsuccessful in obtaining responses in the majority of Itoi 2003 in favour of the reportedly definitive Itoi 2007 to avoid the
cases. Regarding the three newly included studies, we received a potential risk of including data from duplicate populations.
response only from the authors of Chan 2018. Therefore, we had
Four of the reviews conducted subgroup analyses related to the
to mostly rely on the information provided in the study reports
participants' age, based on subgroups of under 30 years and over
for the presentation of the study characteristics and results, and
30 years (Kavaja 2018; Liu 2014; Longo 2014; Vavken 2014; Whelan
for our judgements of risk of bias, which means that our findings
2016). While we have presented the available data for different
and judgements are affected by the completeness and quality of
age categories, we consider there are insufficient data to justify
reporting.
conducting subgroup analysis. The findings of the other reviews
Informed decisions.

were in agreement with our findings in relation to other outcomes, risks for re-dislocation. It would be helpful if investigators consider
as far as these were addressed. the research on literature on risk factors for re-dislocation. Two
recent evidence syntheses suggests that patients' age, presence
All five reviews considered that results were affected by or absence of greater humeral tuberosity fractures, and patients'
methodological limitations and risk of bias in the included studies. sex may be key factors to consider (Olds 2015; Wasserstein 2016).
The two reviews using GRADE assessed the evidence for re- There is a clear need for trials evaluating other conservative
dislocation or recurrence as low quality (Kavaja 2018; Liu 2014); interventions, such as physiotherapy.
these assessments were based on a different set of trials than those
included in our review. Future trials should give careful attention to the choice and
definition of outcome measures. Investigators should use well-
AUTHORS' CONCLUSIONS defined and validated functional outcome measures, and should
include measures of health-related quality of life and satisfaction
Implications for practice with treatment, as these have not yet been evaluated. There is a
All currently available evidence from randomised controlled need for more data on adverse events. The collection of adverse
trials on conservative management following closed reduction events data ad hoc, in the absence of pre-defined definitions or
of traumatic anterior dislocation of the shoulder relates to the strategies for data collection, is a serious flaw that casts doubt on
comparison of immobilisation of the shoulder in external rotation the completeness of data and hampers comparison of beneficial
versus internal rotation. Overall, there is insufficient evidence to and harmful effects. In future studies, key categories of potential
determine whether immobilisation in external rotation confers any adverse events should be established prospectively, and an active
benefit over immobilisation in internal rotation. While there is strategy should be put in place for collecting these data. Categories
some evidence in favour of immobilisation in external rotation, should be reported on even if they contain no events. Attention
the findings are overall uncertain and therefore do not allow should further be given to the appropriate handling (and reporting)
for the conclusion that immobilisation in external rotation is of missing data to minimise the risk of attrition bias.
more effective than immobilisation in internal rotation. Moreover,
There is a need for more consistency and homogeneity across
there is insufficient evidence on adverse events to enable proper
trials regarding relevant aspects including, in particular, follow-
assessment of potential harms. The low certainty of the evidence
up points to enhance comparability across trials. Considering that
for re-dislocation means that further research is very likely to have
most re-dislocations appear to occur within the first year after the
an important impact on our confidence in the estimate of effect.
initial dislocation, a primary follow-up of one year or longer seems
The very low certainty of the evidence for all other outcomes means
reasonable, which could be supplemented by shorter or longer
that any estimate of effect is very uncertain. The effects of the
follow-ups to allow for more differentiated judgements regarding
interventions in different subgroups of patients, such as patients
short-term, medium-term and long-term effects. The availability of
in a specific age group or patients with or without concomitant
individual participant data would be helpful to allow for differential
injuries, is unclear. Thus, there remains a lack of evidence to inform
subgroup analyses related to aspects such as age.
the optimal choice of interventions in clinical practice.
Future studies should also include economic data and consider
Implications for research conducting economic (i.e. cost-effectiveness) analyses.
There remains a need for sufficiently powered, high-quality and
well-reported (i.e. CONSORT-compliant) randomised controlled To ensure that efforts are not duplicated, researchers should
trials of key conservative interventions following closed reduction consult trial registries before planning further research in this area.
after traumatic anterior shoulder dislocation. While some This particularly relates to the comparison between immobilisation
methodological aspects, such as blinding of participants and in external versus internal rotation, along with research that is
personnel, may not always be feasible, others, such as concealed complementary to these; in these areas, pressing priorities include
allocation and blinded outcome assessment, are generally feasible completion of ongoing work and publication of completed work.
and should therefore always be done as they would improve the
ACKNOWLEDGEMENTS
quality and validity of future results.
We are very grateful to Nigel Hanchard, Lorna Goodchild and
Of the four key comparisons that we prespecified as reflecting
Lucksy Kottam for their contributions as authors to the previous
priority questions (see Types of interventions), only one was
version of this review. We thank Joanne Elliott and Maria Clarke
addressed by the included trials. Regarding treatment with
for updating the searches, for conducting the updated searches,
immobilisation, there is a need for evaluations of further aspects
and for providing help during the screening process. We are very
of the use and duration of immobilisation, such as, for example,
grateful to Helen Handoll and Joanne Elliott for providing editorial
immobilisation versus no immobilisation, immobilisation for one
support. We are very grateful to external referees David Annison and
week versus three weeks, or a strict immobilisation regimen
Andrew Cuff for their helpful feedback and insights.
versus a regimen regulated by the patient, and the timing
for resumption of activities that may provoke re-dislocation or We thank Kieran Bentick, Cormac Kelly, Nicholas Noye, Jean-
recurrent symptoms. Future investigations should carefully attend Christophe Pelet, Stéphane Pelet and Timothy Walker for providing
to the evaluation of different subgroups of participants to allow for us information on their trials.
the differentiation of effects between patients who are at different
Informed decisions.

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CHARACTERISTICS OF STUDIES
Characteristics of included studies [ordered by study ID]

Chan 2018
Methods Aim: "...to find out if an ‘off the shelf’ ER [external rotation] brace (Smartsling, Ossur, Reykjavik, Ice-
land) providing 30°of external rotation would reduce re-dislocation rates and improve functional out-
come in patients presenting with a shoulder dislocation, compared to a conventional sling."
Method of randomisation: independently by telephone
Assessor blinding: unclear
Intention-to-treat analysis: yes
Loss to follow-up: there were discrepancies within the report (see notes). In the flow diagram, losses
to follow-up were reported as 18 (25%), comprising 6/36 (17%) in Group A and 12/36 (33%) in Group B
at 12 months; and 15 (21%) comprising 6/36 (17%) in Group A and 9/36 (25%) in Group B at 24 months.
These numbers relate to the secondary outcome; for the primary outcome, data were missing from on-
ly 3 participants (8%) in each group
Participants Setting: 6 (NHS) hospitals in England, UK
Period of data collection: September 2006 to February 2011
Informed decisions.

Chan 2018 (Continued)
Participants: 72 (the initial aim was to recruit 160 participants; however, the trial was discontinued
early due to slow recruitment)
Inclusion criteria: first-time traumatic anterior shoulder dislocation; confirmation of diagnosis by radi-
ography
Exclusion criteria: associated fractures; indication for surgery (as determined by the recruiting sur-
geon); inability to provide informed consent; learning difficulties; mental illness; dementia; significant
comorbidities; unwillingness to participate
Sex: 61 (85%) male
Age: median age Group A 25 years (range 17 to 44) years; Group B 23.8 (range 16 to 43) years
Pre-injury status: no information
Assigned: 36/36 (Group A/B)
Assessed: 30/27 (at final follow-up)
Interventions Group A: immobilisation in an external rotation brace (Smartsling, Ossur, Reykjavik, Iceland) "which
held the arm in 30° of external rotation and 30° of abduction" (p.3)
Group B: immobilisation in internal rotation in a conventional sling (Polysling, Mölnlnlycke Health

Care, Gothenburg, Sweden)
Both groups: the braces and slings were provided in the clinic by "an appropriately trained member of
staff (usually a surgeon, nurse or healthcare assistant)", and all participants were immobilised within
5 days after dislocation (additional information provided by contact author). Patients were instructed
to wear the brace or sling for 4 weeks, both day and night, except when showering or bathing. It is not
clear who applied the brace or sling or gave the accompanying instructions. Patients were instructed
(by a physiotherapist) on a course of shoulder exercises and were provided with written information
and advice for exercising at home. Compliance with exercising was reinforced through a telephone call
by the trial coordinator a few days after the brace or sling had been applied
Outcomes Clinical reviews were conducted at 3, 12 and 24 months post dislocation
Prespecified as primary outcome
Re-dislocation (within 24 months): no information is provided on how re-dislocation was as-

sessed/confirmed. Data were collected by telephone interview if patients did not attend follow-up ap-
pointments
Prespecified as secondary outcomes
Recurrent instability: measured with the Oxford Shoulder Instability questionnaire (OSI) (at 12 and
24 months)
Surgery: "Any shoulder stabilization surgery during the study period was noted." (p.3)
Difficulties with wearing the slings and braces: assessed with a questionnaire
Notes Additional details of this study, including data for re-dislocation at the 3 months' follow-up, were pro-
vided by 1 of the study authors, Dr Kieran Bentick (personal communication 1 September 2018)
The precise method used for the reduction of the shoulder dislocation is not specified ("All trial partic-
ipants received standard manipulation under local or general anaesthetic to reduce the dislocation in
the acute setting..." [p.3])
Unit of analysis: in this study, there were 72 cases of dislocation in 71 patients. 1 patient experienced a
dislocation of the right shoulder 3 years after the dislocating the left, and was randomised twice (addi-
tional information provided by contact author)
Loss to follow-up: discrepant numbers were reported in the flow diagram, text and outcome table,
and different numbers of participants were reported for the outcomes. The discrepancies were ex-
plained by the contact author as follows (personal communication, 1 September 2018): "At the conclu-
sion of the trial once the data had been collected patients were contacted and further information was
gained from records held at the hospitals randomising the patients. This was achieved by reviewing
clinic letters from additional appointments. Between the two sufficient information was acquired to as-
Informed decisions.

certain when and whether further dislocations had occurred in most cases (33 in each group). The con-
sort flow diagram was however not altered."
Recurrent instability/OSI (at 24 months): this was specified both as a primary and a secondary out-
come in the Methods section of the report, but was reported only with the secondary outcomes in the
Results section; hence, it was considered a secondary outcome in this review
Relationship between this and previous reports: in the conference abstract by Kelly 2011 (includ-
ed as study awaiting classification in Hanchard 2014), preliminary results of this study relating to out-
comes after 1 year were reported
Funding sources and declarations of interest:
Funding: "This work was supported by: The British Elbow and Shoulder Society; Institute of Or-
thopaedics, Robert Jones and Agnes Hunt Hospital, Oswestry Shropshire; Ossur UK provided the ER
braces and were not involved in the design, data analysis or preparation of this paper."
Declaration of Conflicting Interests: "The author(s) declared no potential conflicts of interest with re-
spect to the research, authorship, and/or publication of this article."
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence genera- Low risk Quote: “Randomisation was carried out independently by the York Trials Unit
tion (selection bias) by telephone, with participants assigned to receive a conventional sling ... or
an ER brace...” (p.3).
Allocation concealment Low risk Comment: allocation was done centrally (York Trials Unit, by telephone).
(selection bias)
Blinding of participants High risk Quote: "Due to the nature of the intervention, blinding of the patient or index
and personnel (perfor- surgeon was not possible.” (p.3).
mance bias)
All outcomes Comment: the care providers could also not be blinded.
Blinding of outcome as- Unclear risk Quote: “Clinical and functional evaluations […] were conducted by site co-
sessment (detection bias) ordinators." (p.3). "All outcomes were [...] collected by a research co-ordina-
Re-dislocation tor.” (p.3).
Comment: it is not clear whether these coordinators were blinded. It is unclear

how re-dislocation was diagnosed and verified; outcome data were collected
by telephone interview if patients failed to attend follow-up appointments. It
seems that the outcome was at least partly patient-reported, hence involving
subjective assessment.
Blinding of outcome as- High risk Comment: this outcome (OSI) was patient-assessed and hence inherently un-
sessment (detection bias) blinded. The review authors judge that it is likely that the subjective outcome
Validated PROMs for measurement may have been influenced by lack of blinding (considering also
shoulder instability that the participants were unblinded to their treatment allocation).
Blinding of outcome as- Unclear risk Comment: there was insufficient information about how adverse events were
sessment (detection bias) assessed to make a judgement of 'low risk' or 'high risk' of bias.
Adverse events
Incomplete outcome data Low risk Comment: the amount of attrition for re-dislocation was 8% and identical in
(attrition bias) both groups. The review authors considered it unlikely that this amount of
Re-dislocation, longest or losses to follow-up would have affected the results for re-dislocation. No miss-
main follow-up ing data were replaced.
Informed decisions.

Incomplete outcome data High risk Comment: attrition was unbalanced between both groups at the 12 months'
(attrition bias) and 3 months' follow-up, and high in the internal rotation group (33% versus
Re-dislocation, other fol- 14% at 12 months; 22% versus 8% at 3 months. The reported reason for all
low-ups losses to follow-up was the inability to contact these participants. No missing
data were replaced.
Incomplete outcome data High risk Comment: attrition for the OSI was unbalanced between both groups at the
(attrition bias) 24 months' and 12 months' follow-up, and high in the internal rotation group
Validated PROMs for (31% versus 17% at 24 months; 33% versus 17% at 12 months. The report-
shoulder instability ed reason for all losses to follow-up was the inability to contact these partici-
pants. No missing data were replaced.
Incomplete outcome data Unclear risk Comment: there was insufficient information to make a judgement of 'low risk'
(attrition bias) or 'high risk' of bias.
Adverse events
Selective reporting (re- Unclear risk Comment: no registration record or published protocol is available for this
porting bias) study. Kelly 2011, a conference abstract that was included as study awaiting
classification in the previous version of the review, provided insufficient infor-
mation for a judgement. Hence, there is insufficient information available to
permit a judgement of ‘low risk’ or ‘high risk’.
Other bias Low risk Comment: none identified.

Finestone 2009
Methods Aim: "To ascertain whether immobilisation after primary traumatic anterior dislocation of the shoulder
in external rotation was more effective than immobilisation in internal rotation in preventing recurrent
dislocation in a physically active population"
Method of randomisation: computer-generated randomised list
Assessor blinding: no
Intention-to-treat analysis: no information
Loss to follow-up: none
Participants Setting: Accident and Emergency Department of a University hospital, Israel
Period of data collection: 1 January 2004 to 31 December 2006 (additional information provided by
contact author)
Participants: 51
Inclusion criteria: primary anterior dislocation of the shoulder; informed consent. It is unclear
whether the exclusive recruitment of males was by chance or by intention
Exclusion criteria: injury sustained in a motor vehicle accident; concurrent fracture of the greater
tuberosity
Sex: 51 male
Age: mean 20 years, range 17 to 27 years
Pre-injury status: 22/27 (81.5%) in Group A and 18/24 (75%) in Group B were soldiers (additional infor-
mation provided by contact author)
Informed decisions.

Finestone 2009 (Continued)
Interventions Group A: immobilisation in 15° to 20° of shoulder external rotation in a manufactured device (manu-
facturer's details not given), except when showering or changing clothes. No information was given on
who applied the splint or gave the accompanying instructions
Group B: immobilisation in an internal rotation brace with a component encircling the lower arm to
maintain elbow adduction, except when showering or changing clothes. No information was given on
who applied the splint or gave the accompanying instructions
Both groups: after 4 weeks' immobilisation, participants began a standard regimen of physiotherapy
(no further details were given). Participants with clinically stable shoulders on the basis of a negative
supine apprehension test returned to full activity after 3 months
Outcomes Reviews were conducted at 2 and 6 weeks, 3 and 6 months, and 1, 2, 3 and 4 years post-injury
None of the outcomes was prespecified with the methods
Re-dislocation: not further defined; it is unclear whether this was verified by reference to the medical
notes, but this is likely to have been so, given the population in question. Identified re-dislocators were
further evaluated: "Those who sustained re-dislocations were evaluated by either CT or MRI arthrogra-
phy" (p.919)
Adverse events: undefined
Adherence: compliance with treatment; undefined (the reported results relate to whether the braces
or slings were worn over the full immobilisation period)
Surgical intervention: rate of participants with re-dislocation who had undergone surgery when last
reviewed (all were soldiers)
Notes At injury, 5/27 (18.5%) in Group A and 5/24 (20.8%) in Group B had sustained axillary nerve neuropraxia.
This resolved within 10 weeks in all cases. There were no fractures of the glenoid rim
Closed reduction was performed in the Accident and Emergency Department by the Milch technique (n
= 41) or the Hippocratic method (n = 10; 7/27 = 25.9% in Group A and 3/24 = 12.5% in Group B (addition-
al information provided by contact author))
Re-dislocations: these occurred at a mean of 13.8 months (range 4 to 43 months) after the first in
Group A, and 12.4 months (range 4 to 46 months) after the first in Group B. Re-dislocators were evaluat-
ed by CT or MRI arthrography. 19/20 (95%) were found to have a Bankart lesion, 1 of which was bony
"This study has been supported by a research grant of the IDF Medical Corporation and Israeli Ministry
of Defence. No benefits in any form have been received or will be received from a commercial party re-
lated directly or indirectly to the subject of this article."
Risk of bias
Random sequence genera- Low risk Quote: "We aimed to have 55% of the patients in the external rotation brace ...
tion (selection bias) we made up prior to the study 100 patient booklets numbered 001 to 100. Each
booklet had a sealed envelope which contained either a slip for external or in-
ternal rotation bracing. The slips were placed into their respective envelopes
according to a computer generated randomised list based on the file num-
ber" (additional information provided by contact author).
Allocation concealment Low risk Comment: see above

(selection bias)
Informed decisions.

Finestone 2009 (Continued)
Blinding of participants High risk Comment: blinding of participants and personnel (care providers) was not
and personnel (perfor- possible.
mance bias)
All outcomes
Blinding of outcome as- Unclear risk Comment: there is no mention of blinding, and the outcome of "recurrent dis-
sessment (detection bias) location" is not sufficiently defined to allow for a clear judgement of 'low risk'
Re-dislocation or 'high risk' of bias.
Blinding of outcome as- Unclear risk Comment: there is insufficient information about how adverse events were as-
sessment (detection bias) sessed to allow for a judgement of 'low risk' or 'high risk' of bias.
Adverse events
Incomplete outcome data Low risk Comment: outcome data for re-dislocation is provided for all 51 participants.
(attrition bias) Participants appear to have been followed up to 4 years or the point of re-dis-
Re-dislocation, longest or location, whichever was sooner. "No patient was lost to follow up" (additional
main follow-up information provided by contact author).
Incomplete outcome data Unclear risk Comment: there is insufficient information on how (including from how many
(attrition bias) participants) data on adverse events and adherence were collected to allow
Adverse events for a judgement of 'low risk' or 'high risk' of bias.
Selective reporting (re- Unclear risk Comment: no protocol is available, but most key outcomes were reported. The
porting bias) numbers with clinical instability at 3 months, based on the supine instability
test, were not reported. Group data on the numbers of participants requiring
surgery were not given in the paper but were provided on request by the con-
tact author.

Heidari 2014
Methods Aim: to compare "the effectiveness of the nonsurgical treatments of immobilization in abduction and
external rotation vs immobilization in adduction and internal rotation after the primary anterior shoul-
der dislocation. We aimed to compare functional outcome and stability results between these two po-
sitions of shoulder stabilization."
Method of randomisation: computer-generated randomisation scheme
Assessor blinding: unclear
Intention-to-treat analysis: yes (unclear wording in the Methods section of the report; however, all
participants received the intervention they were allocated to)
Loss to follow-up: 5 (5%) comprising 3/51 (6%) in Group A and 2/51 (4%) in Group B
Participants Setting: emergency department of a university-affiliated hospital, Iran
Period of data collection: October 2011 to March 2013

Participants: 102
Inclusion criteria: primary unilateral anterior dislocation of the shoulder (all patients were initially as-
sessed by radiography); presentation to the emergency department within 6 hours post-injury; age 15
to 55 years; willingness to be followed up
Exclusion criteria: previous shoulder problems; surgical joint repair; multidirectional instability;
shoulder injuries requiring surgical intervention; associated fractures of the shoulder according to re-
sults of routine radiographic examination; unwillingness to be followed up for 24 months.
Sex: 91 (89%) male
Age: 35.8 years, SD 8.9 years
Informed decisions.

Heidari 2014 (Continued)
Subgroups: by age < 20 years; 21 to 30 years; 31 to 40 years; ≥ 41 years
Pre-injury status: 31/51 in Group A and 38/51 sustained their injury in sport activities. 20/51 in Group A
and 13/51 in Group B sustained their injury in a trauma
Interventions Group A: immobilisation for 3 weeks in 15° of abduction and 10° of external rotation in a "stabilizer
brace with an adjustable angle of abduction" (picture provided in study report). Part of the (fixation of
the) brace came from Velcro (Velcro USA Inc, Manchester, NH, USA)
Group B: immobilisation for 3 weeks in internal rotation in a "sling and swathe bandage" (not further
described)
Both groups: presumably, immobilisation started very soon after dislocation (all included presented
to the emergency department within 6 hours). It is not clear who applied the brace or sling or gave the
accompanying instructions. Patients were instructed to remove their brace or sling only during show-
ering and were advised "to be cautious about hyperextension of the joint". They were further asked not
"to change the position of the brace and to use the contralateral upper extremity to perform activities.”
Following the immobilisation period, all participants underwent an identical exercise-based rehabilita-
tion program, which was supervised by a physiotherapist. No information is provided on the duration,
frequency and intensity of rehabilitation. The participants were advised not to initiate sportive activi-
ties for at least 3 months post-intervention
Outcomes Follow-up assessments were conducted at 3 weeks post-intervention, at 24 months post-dislocation

and 33 months (WOSI only) post-dislocation
Prepecified as primary outcome
Re-dislocation: "defined as the humeral head being completely or partially out of the glenoid sock-
et that reduced spontaneously or by manual maneuver." At the 3-week follow-up patients were asked
whether they had experienced any further dislocations. It seems that outcomes at 24 and 33 months
were mostly collected by telephone interviews (in cases where the patient could not be contacted, ef-
forts were made to arrange for a direct examination at a clinic or at the patient's home)
Instability ‒anterior apprehension test (at the 3-week follow-up), tested in supine position, with the
arm being placed in 90° of shoulder abduction and 90° of elbow flexion; stress on the glenohumeral
joint was applied by an external rotation force "until the patient became apprehensive". The feeling
that the shoulder would "come out of joint" was considered a positive test result
Return to pre-injury sports: not further specified
Adherence: "proportion of non-cooperative patients", assessed by the question: "Please indicate how
many hours a day and for how long you wore the immobilizer." Participants who took off the brace or
sling during the immobilisation period, except when taking a shower, were defined as non-cooperative
participants
Western Ontario Shoulder Instability Index (WOSI)
Adverse events: not prespecified as an outcome, undefined
Surgical intervention: not prespecified as an outcome. "Patients in both groups who experienced re-
current symptomatic instability at any time during the study underwent surgical intervention accord-
ing to the orthopedic surgeon’s discretion." (p.761). This is not further addressed; it is unclear whether
patients who underwent surgery were excluded from the study
Notes The methods used for reduction of the shoulder dislocation were the traction-countertraction manoeu-
vre in 79 patients (77.4%) and Kocher’s method in 23 (22.6%)
Not all outcomes were assessed at all follow-up time points. At the 33-month follow-up, only the WOSI
was assessed. Results for the WOSI are only reported for the 33-month follow-up. No results are report-
Informed decisions.

ed for the follow-up at 3 weeks post-intervention. The presented results for re-dislocation, apprehen-
sion and return to sports relate to the 24-month follow-up, same as for adverse events
Funding and declarations of interest:
"The investigation was financially supported by a grant from Shahid Beheshti University of Medical
Sciences, Iran (No. 16X-03B-76349). The authors, their immediate families, and any research founda-
tions with which they are affiliated have not received any financial payments or other benefits from any
commercial entity related to the subject of this article."
Risk of bias
Random sequence genera- Low risk Quote: "The patients were randomly assigned (in a 1:1 ratio) … according to a
tion (selection bias) computer-generated randomization scheme." (p.760).
Allocation concealment Unclear risk Quote: “Each … physician was provided with a set of opaque envelopes con-
(selection bias) taining group assignment.” (p.760).
Comment: it remains unclear whether envelopes were sequentially numbered,

and sealed. Hence, the information was considered insufficient to permit a de-
finitive judgement of ‘low risk’ or ‘high risk’.
mance bias)
All outcomes
Blinding of outcome as- Unclear risk Comment: there was no mention of blinding. It seems that re-dislocation at 24
sessment (detection bias) months was mostly assessed by telephone interview, i.e. subjectively.
Re-dislocation
Blinding of outcome as- High risk Comment: the WOSI was patient-assessed and hence inherently unblinded.
sessment (detection bias) The review authors judge that it is likely that estimates may have been influ-
Validated PROMs for enced by lack of blinding (considering also that the participants were unblind-
shoulder instability ed to their treatment allocation).
Blinding of outcome as- Unclear risk Comment: return to sportive activities was patient-assessed and was hence in-
sessment (detection bias) herently unblinded. The review authors judged that it is possible that the out-
Resumption of pre-injury come measurement may have been influenced by lack of blinding. However,
activities/sports this outcome was judged to be less prone to bias than other patient-reported
outcomes and risk of bias was therefore rated as unclear.
Blinding of outcome as- Unclear risk Comment: the positive apprehension test was conducted by an examiner.
sessment (detection bias) However, as there was no mention of blinded outcome assessors, a judgement
Any instability of ‘low risk’ or ‘high risk’ was not possible.
Adverse events
Incomplete outcome data Low risk Comment: there were reportedly no losses up to the 24-month follow-up;
(attrition bias) hence, this is not considered a potential source of bias. No information is pro-
Re-dislocation, longest or vided about the planned or applied approach to missing outcome data; how-
main follow-up ever, it seems that no missing data were replaced.
Incomplete outcome data Low risk Comment: the amount of losses to the 33-month follow-up was small and sim-
(attrition bias) ilar across the groups (3/51 (6%) in Group A and 2/51 (4%) in Group B).
Informed decisions.

Validated PROMs for
shoulder instability
Incomplete outcome data Low risk Comment: the numbers of participants for whom resumption of pre-injury ac-
(attrition bias) tivities is reported relate to a subgroup of participants. In view of the small
Resumption of pre-injury number or losses to follow-up, risk of attrition bias for this outcome was rated
activities as low.
Incomplete outcome data Low risk See above.

(attrition bias)
Any instability
Incomplete outcome data Unclear risk Comment: there was insufficient information to make a judgement of 'low risk'
(attrition bias) or 'high risk' of bias.
Adverse events
Selective reporting (re- Unclear risk Comment: no registration record or published protocol is available for this
porting bias) study. There is insufficient information available to permit a judgement of ‘low
risk’ or ‘high risk’. 2 outcomes (adverse effects and surgical intervention) were
not prespecified with the methods but were reported with the results.

Itoi 2007
Methods Aim: "To report the two-year results of a study testing the hypothesis that immobilization in external
rotation versus internal rotation would reduce the recurrence rate after initial traumatic anterior dislo-
cation of the shoulder"
Method of randomisation: random number table
Loss to follow-up: 39/198 (19.7%), comprising 19/104 (18.3%) in Group A and 20/94 (21.3%) in Group B
Participants Setting: Akita Hospital and 11 other institutes across Japan
Period of data collection: October 2000 to March 2004
Participants: 198
Inclusion criteria: initial anterior dislocation caused by a substantial traumatic event; presentation
within 3 days (including the day of dislocation); no associated fracture visible on routine radiographic
examination; informed consent
Exclusion criteria: no information was given
Sex: 136 male (67%)
Subgroups:
By age ≤ 20 years; 21 to 30 years; ≤ 30 years; 31 to 40 years; ≥ 41 years
By interval between dislocation and immobilisation: 0 days; 1 day; 2 days
Informed decisions.

Itoi 2007 (Continued)
By age and interval between dislocation and immobilisation: age ≤ 30 years and interval 0 days; age ≤
30 years and interval 1 day; age ≤ 30 years and interval 2 days
Pre-injury status: 71/104 (68.3%) in Group A and 64/94 (68.1%) in Group B sustained their injury in
sport. Among participants aged < 30 years, 53/56 (94.6%) in Group A and 39/42 (92.3%) in Group B sus-
tained their injury in sport
Interventions Group A: immobilisation in 10° of external rotation, except when showering. Until November 2003, this
was achieved using a wire-mesh splint covered with sponge and stockinette (see Itoi 2003 for details).
Starting in November 2003, a prototype manufactured brace was used (Alcare, Tokyo, Japan). Both
methods appeared to limit wrist mobility. The treating surgeons (possibly authors of the report) ap-
plied the splintage and gave the accompanying instructions
Group B: immobilisation in a sling and swathe except when showering. The treating surgeons (possibly
authors of the report) applied the splintage and gave the accompanying instructions
Both groups: immobilisation commenced between zero and 2 days post dislocation (day 1 to 3) and
was continued for 3 weeks. Afterwards, rehabilitation comprised self-directed active and passive range-
of-motion exercises. Avoidance of vigorous sports activities for at least 3 months was advised
Outcomes Follow-up reviews were conducted at 6, 12 and 24 months (presumably after initiation of immobilisa-
tion), face-to-face or by telephone
Prespecified as the primary outcome
Self-reported re-dislocation or subluxation: dislocation was defined as "the humeral head being
completely out of the glenoid socket until a reduction maneuver was performed, and subluxation was
defined as the humeral head being completely or partially out of the glenoid socket but reducing spon-
taneously." (p.2127). The participants were asked whether they had experienced any further disloca-
tion or subluxation after the immobilization
Implicitly secondary outcomes
Return to pre-injury sport: at any level (subgroup who sustained injury in sport); at pre-injury level
(subgroup who sustained injury in sport); at any level (subgroup aged ≤ 30 years who sustained injury
in sport); at pre-injury level (subgroup aged ≤ 30 years who sustained injury in sport)
Adherence: use of splint full- or part-time for full 3 weeks; use of splint full-time for full 3 weeks
Adverse events: not prespecified as an outcome, undefined
Surgical intervention: participants with recurrent dislocations or subluxations who "eventually un-
derwent surgical stabilization" (p.2128)
Notes Relationship between this and previous reports: the full trial report of Itoi 2003 indicated that this
was a preliminary study. A subsequent (2004) abstract stated that it was an interim report of an ongo-
ing trial, referred to the random assignment of 96 participants and reported results for 80 participants.
The selection criteria had changed in that participants with recurrent dislocations were now included,
but humeral fractures were explicitly excluded, as were shoulders not immobilised within 3 days of in-
jury. The mean follow-up time in the 2004 abstract was 12.4 months
Correspondence with Prof Itoi (July 2005) revealed that the trial was still ongoing. Results for 131 par-
ticipants, all with initial dislocations, were reported at an Instructional Course Lecture (Principles and
procedures for shoulder instability: an international perspective: non-operative management of anteri-
or instability) at the meeting of the American Academy of Orthopaedic Surgeons in 2005 (handout pro-
vided to authors by Prof Itoi)
Itoi 2007 reports results for 198 participants with initial dislocation, recruited from October 2000, and
correspondence with Prof Itoi (8 April 2011) indicates that this study sample does not incorporate that
Informed decisions.

of Itoi 2003. However, the start point and selection criteria of Itoi 2007 may not have been determined
prospectively, contributing to the grading of “unclear” in the “selection bias” section of the risk of bias
table
Method of reduction: manual reduction was by the elevation method (101 shoulders, 57 in Group A),
the Hippocratic method (22 shoulders, 13 in Group A), the external rotation method (17 shoulders, 8
in Group A), the Kocher method (16 shoulders, 6 in Group A), the Stimson method (14 shoulders, 8 in
Group A) and other methods (28 shoulders) (additional information provided by contact author)
External rotation brace: adoption of the Alcare brace, which was easier to do on and off than the wire-
mesh splint, may have influenced adherence, as well as positioning and standardisation, part way
through the study
Re-dislocations: mostly occurred during the first year (82% of those in Group A and 84% of those in
Group B)
Funding and declarations of interest: "In support of their research for or preparation of this work,
one or more of the authors received, in any one year, outside funding or grants of less than $10,000
from Alcare, Tokyo, Japan. One or more of the authors, or a member of his or her immediate family, re-
ceived, in any one year, payments or other benefits of less than $10,000 or a commitment or agreement
to provide such benefits from a commercial entity (Al- care, Tokyo, Japan). No commercial entity paid
or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center,
clinical practice, or other charitable or nonprofit organization with which the authors, or a member of
their immediate families, are affiliated or associated."
Risk of bias
Random sequence genera- Low risk Quote: "Randomization was performed with the use of a random-number ta-
tion (selection bias) ble created by the principal investigator. Co-investigators allocated the pa-
tients at their institutes with the use of this random number table." (p.2125).
Allocation concealment High risk Comment: the random-number table was probably open: see above.
(selection bias)
mance bias)
All outcomes The instructions on the immobilisation protocol were given by the treating
surgeons.
Quote: "We and the other treating surgeons might have made a stronger effort
to ensure adherence to the external rotation immobilization".
Blinding of outcome as- Unclear risk Comment: return to sports was patient-assessed and was hence inherently un-
sessment (detection bias) blinded. The review authors judged that it is possible that the outcome mea-
Resumption of pre-injury surement may have been influenced by lack of blinding. However, this out-
activities/sports come was judged to be less prone to bias than other patient-reported out-
comes and risk of bias was therefore rated as unclear.
Blinding of outcome as- High risk Comment: there is no mention of blinding. Recurrence, which comprised self-
sessment (detection bias) reported re-dislocation or subluxation, was clearly defined, but subluxation is
Any instability inevitably subjective.
Blinding of outcome as- Unclear risk There was insufficient information about how adverse events were assessed to
sessment (detection bias) make a judgement of 'low risk' or 'high risk' of bias.
Adverse events
Incomplete outcome data High risk The numbers of participants for whom resumption of pre-injury sports activ-
(attrition bias) ities is reported relate to a subgroup of participants. It is likely that the high
Informed decisions.

Resumption of pre-injury number of losses to follow-up attrition may have affected the results of this
activities outcome.
Incomplete outcome data High risk Comment: attrition for recurrent instability was high in both groups (18.3% in
(attrition bias) Group A and 21.3% in Group B), and no reasons were provided. No information
Any instability is provided about the planned or applied approach to missing outcome data;
however, it seems that no missing data were replaced.
Incomplete outcome data High risk There was insufficient information. However, in view of the high number of
(attrition bias) losses to follow-up, risk of attrition bias was judged as high for this outcome,
Adverse events too.
Selective reporting (re- High risk Comment: no protocol is available. Key outcomes were reported, but the start
porting bias) point and selection criteria are inconsistent across reports and may not have
been determined prospectively.
Other bias High risk Comment: there is disclosure of funding or grants of < $10,000 by Alcare to 1 or
more of the authors in support of preparation for the research. There is disclo-
sure of payments or benefits of < $10,000 by Alcare to 1 or more of the authors
or their immediate families.

Liavaag 2011
Methods Aim: "To compare immobilization in internal rotation and external rotation after anterior shoulder dis-
location"
Method of randomisation: block randomisation
Loss to follow-up: 4/188 (2.1%) comprising 2/93 (2.2%) in Group A and 2/95 (2.1%) in Group B as
shown in the flow diagram. The reported numbers of participants with outcome data differed across
outcomes. For subluxation, the loss to follow-up was 25/188 (13%), comprising 12/93 (13%) in Group A
and 13/95 (14%) in Group B; for return to pre-injury level of physical activity with the affected shoulder
it was 19/188 (10%), comprising 10/93 (11%) in Group A, and 9/95 (9%) in Group B
Participants Setting: Emergency Department of 13 hospitals in Norway
Period of data collection: January 2005 to February 2008
Participants: 188
Inclusion criteria: age 16 to 40 years; successful reduction of primary traumatic anterior dislocation
documented on conventional radiographs
Exclusion criteria: fractured glenoid with a large bony defect (including > 20% of the glenoid rim) or
a bony defect involving > 1/3 of the diameter of the glenoid fossa at the same level; fractured greater
tuberosity with malalignment after repositioning; neuropathy related to dislocation or reduction; un-
willingness or inability to participate
Sex: 153 male (81%)
Age: mean 26.8 years, SD 7.1 years
Subgroups: age 16 to 24 years; age 25 to 40 years
Pre-injury status: 44/93 (47.3%) in Group A and 39/95 (41.1%) in Group B sustained their injury in
sport. The ratio of minor to major trauma was 52:41 in Group A and 48:47 in Group B. 2 participants in
Informed decisions.

Liavaag 2011 (Continued)
each group had positive sulcus signs. 6 participants in Group A and 8 in Group B had other signs associ-
ated with generalised ligamentous laxity
Interventions Group A: immobilisation in an appropriately sized, manufactured shoulder immobiliser (15-degree Ul-
trasling ER, DonJoy, Vista, California) in 15° of external rotation, except when showering. A line at the
top of the immobiliser was parallel to the frontal plane when the arm was correctly positioned. The im-
mobiliser incorporated the wrist. No information was given on who applied the immobilisation or gave
the accompanying instructions
Group B: immobilisation in a collar and cuff or a sling and swathe, except when showering. No informa-
tion was given on who applied the immobilisation or gave the accompanying instructions
Both groups: immobilisation commenced immediately after reduction (within 24 hours after disloca-
tion) and continued for 3 weeks. No information was given on rehabilitation.
Outcomes A standardised questionnaire was sent to participants 2 years post-dislocation. Adherence data were
gathered at 3-week follow-up
Prespecified as the primary outcome
Self-reported (and verified) re-dislocation: dislocation was defined as the humeral head being com-
pletely out of the glenoid until a reduction manoeuvre was performed. Participants recorded the date
of the first recurrent dislocation on the questionnaire and this was confirmed by reference to medical
records
Self-reported subluxation: subluxation was defined as the humeral head being partially out of the
glenoid
Self-reported recurrent instability: recurrent dislocation or subluxation
Resumption of pre-dislocation level of physical activity
Adverse events: assessed with a questionnaire asking whether there were any persistent complaints
caused by the shoulder dislocation (additional information provided by contact author)
Surgical intervention: "surgical treatment of instability" (p.899)
Adherence: daily immobilisation was recorded as "not at all," "up to 8 hours," "between 8 and 16
hours" and "more than 16 hours". The number of days on which immobilisation was used was also
recorded. Participants who used immobilisation for > 16 hours daily for at least 20 days were labelled
compliant
Notes "There was no difference between the randomised groups in terms of demographic characteristics" at
baseline
Physicians were allowed to choose the method of reduction according to personal preference. Details
were not reported
5 deviations from protocol were analysed as randomised in the intention-to-treat analysis, as follows:
2 participants in Group A were enrolled despite being ineligible (they were recurrent dislocators); 1 par-
ticipant in Group B was enrolled despite being ineligible (this participant was a recurrent dislocator); 2
participants in Group A were incorrectly immobilised in internal rotation
Re-dislocations: mean time to re-dislocation was 10.5 months (range 1 week to 2 years) in Group A and
11.6 months (range 2 months to 2 years) in Group B
Informed decisions.

Self-reported recurrent instability: a discrepancy was noted. Participants with recurrent instability
(re-dislocation or subluxation) are reported as a percentage of the full sample (N = 184), and yet "only
163 patients answered the question as to whether they had experienced subluxation". There appears
to have been an assumption that non-responders had not experienced subluxation. Because the distri-
bution of responses across the 2 groups is unknown, the data are not usable in a meta-analysis
WOSI data: were reported to be not normally distributed. The individual data were unavailable to us,
precluding analysis
"The authors did not receive any outside funding or grants in support of their research for or prepara-
tion of this work. Neither they nor a member of their immediate families received payments or other
benefits or a commitment or agreement to provide such benefits from a commercial entity."
Risk of bias
Random sequence genera- Low risk Quotation: "Block randomization was conducted for each hospital" (p.898).
tion (selection bias)
Comment: it is unclear how the sequences were generated.
Allocation concealment Unclear risk Quotation: "Concealed randomization was performed according to the
(selection bias) method described by Altman, and sealed envelopes were used," (p.898).
Comment: specific details were not given.
mance bias)
All outcomes Participants were informed of the preliminary results of Itoi 2007 (favouring
immobilisation in external rotation), which may have influenced adherence.
Blinding of outcome as- Low risk Comment: there is no mention of blinding, but the primary outcome measure,
sessment (detection bias) re-dislocation, was clearly defined, and participant reports were verified by
Re-dislocation reference to their medical records.
Blinding of outcome as- High risk Comment: the WOSI was patient-assessed and hence inherently unblinded.
sessment (detection bias) The review authors judge that it is likely that estimates may have been influ-
Validated PROMs for enced by lack of blinding (considering also that the participants were unblind-
shoulder instability ed to their treatment allocation).
Blinding of outcome as- Unclear risk Comment: return to sportive activities was patient-assessed and was hence in-
sessment (detection bias) herently unblinded. The review authors judged that it is possible that the out-
Resumption of pre-injury come measurement may have been influenced by lack of blinding. However,
activities/sports this outcome was judged to be less prone to bias than other patient-reported
outcomes and risk of bias was therefore rated as unclear.
Blinding of outcome as- High risk Comment: subluxation was patient-reported and was hence inevitably subjec-
sessment (detection bias) tive.
Any instability
Adverse events
Incomplete outcome data Low risk Comment: the proportion of losses to follow-up for re-dislocation was very
(attrition bias) small (2/95 (2%) for Group A and 2/93 (2%) for Group B, and was insufficient to
Re-dislocation, longest or have a clinically relevant impact on estimates of effect. No information is pro-
main follow-up
Informed decisions.

vided about the planned or applied approach to missing outcome data; how-
ever, it seems that no missing data were replaced.
Incomplete outcome data Low risk Attrition was low for this outcome (5% in each group).
(attrition bias)
Validated PROMs for
Incomplete outcome data Low risk Comment: attrition for this outcome was 11% in the external rotation group
(attrition bias) and 10% in the internal rotation group. The review authors judged that it is un-
Resumption of pre-injury clear whether this may have had an effect on the result.
activities
Incomplete outcome data Unclear risk Comment: attrition for subluxation was 13%, but was similar in both groups
(attrition bias) (13% in Group A and 14% in Group B). The review authors judged that it is un-
Any instability clear whether this may have had an effect on the result.
Incomplete outcome data Unclear risk Comment: there was insufficient information to allow for a judgement of 'low
(attrition bias) risk' or 'high risk' of bias.
Adverse events
Selective reporting (re- Low risk Comment: a protocol was published (ClinicalTrials.gov Identifier:
porting bias) NCT00202735), and the study's prespecified primary outcome was reported.

Taskoparan 2010
Methods Aim: "To compare the functional and stability outcomes of the patients with acute anterior shoulder
dislocation, who were stabilised at external versus internal rotation"
Method of randomisation: alternation based on Emergency Department numbers
Intention-to-treat analysis: no
Loss to follow-up: Rowe and Constant-Murley scoring was planned at 6 months, and control examina-
tions (radiography and MRI) at 6, 12 and 24 months, thus a 2-year follow-up. Presumably the intent was
to follow up re-dislocations for the same period. However, individual data in Table 1 indicate that on-
ly 12/16 (75%) participants in Group A and 13/17 (76.5%) in Group B were followed up to 1 year (or were
already accounted for as re-dislocators). Only 6/16 (37.5%) participants in Group A and 11/17 (64.7%) in
Group B were followed up to 2 years (or were already accounted for as re-dislocators). Thus, while there
was no loss to follow-up at the short-term (6-month time point), there was potentially important loss at
1 year (25% in Group A, 23.5% in Group B) and especially at 2 years (62.5% in Group A, 35.3% in Group
B)
Participants Setting: Emergency Department in Turkey
Period of data collection: 2004 to 2008
Participants: 33
Inclusion criteria: acute primary traumatic anterior dislocation; admission on the first day of reduc-
tion
Exclusion criteria: hyperlaxity; [implicitly] neural damage
Sex: 31 male (94%)
Informed decisions.

Taskoparan 2010 (Continued)
Age: mean 34.9 years (SD 17.9 years) in Group A, 28.9 years (14.8 years) in Group B (range 15 to 75)
Subgroups: age < 20 years, n = 1; age 21 to 30 years, n = 21; age 31 to 40 years, n = 4; age > 40 years, n =
7
Pre-injury status: 7/16 (43.8%) in Group A and 9/17 (52.9%) in Group B sustained their injury in sport
Assessed: 16/17 (at 6 months); 12/13 (at 1 year); 6/11 (final follow-up at 2 years)
Interventions Group A: immobilisation in 10° of external rotation in a locally-manufactured, hard polyethylene splint,
removed only for showering. The immobiliser incorporated the wrist. No information was given on who
applied the immobilisation or gave the accompanying instructions
Group B: immobilisation in Velpeau bandaging on the first day, switching to a "waist-assisted sling on
the second day", removed only for showering. No information was given on who applied the immobili-
sation or gave the accompanying instructions
Both groups: immobilisation commenced on the first day after reduction and continued for 3 weeks.
Immediately afterwards, rehabilitation commenced, initially with isometric and pendular exercises.
When isometric exercises were painless, isotonic exercises were commenced. Avoidance of sporting ac-
tivities for 3 months was recommended
Outcomes Follow-up points were 6 months (Constant-Murley score, Rowe score), 1 year and 2 years (radiographs
and MRI) and unspecified (re-dislocation, adverse events, apprehension test)
(Outcomes were not prespecified as primary or secondary)
Re-dislocation: was not specified as an outcome with the methods but was reported in the results. The
mechanism for gathering these data was not reported
Constant-Murley score (not used in review)
Rowe score (not used in review)
Adverse events: were not prespecified as an outcome, but severe functional limitation was reported in
1 participant
'Intimidation test': this was presumably meant to be the apprehension test, but no further informa-
tion was given
Difficulties with wearing the slings and braces: observation only
Notes "Both groups were similar in basic clinical parameters"
Method of reduction: reduction was by the Hippocratic method in 20 participants (11 in Group A), the
Kocher manoeuvre in 12 participants (5 in Group A) and the Stimson manoeuvre in 1 participant (Group
B)
Funding sources and declarations of interest: no information.
Risk of bias
Random sequence genera- High risk Quote: "Patients with odd emergency department administration numbers re-
tion (selection bias) ceived stabilization at internal rotation ... and patients with even numbers re-
ceived stabilization at external rotation."
Allocation concealment High risk Comment: allocation was based on case record number (see above).
(selection bias)
Informed decisions.

Taskoparan 2010 (Continued)
mance bias)
All outcomes
Blinding of outcome as- Unclear risk Comment: there is no mention of blinding and there was insufficient informa-
sessment (detection bias) tion about how re-dislocation was assessed and verified. Hence, there is insuf-
Re-dislocation ficient information to allow for a judgement of 'low' or 'high' risk of bias.
Blinding of outcome as- Unclear risk Comment: there is no mention of blinding and there was insufficient informa-
sessment (detection bias) tion about how the 'intimidation' test was assessed. Hence, there is insuffi-
Any instability cient information to allow for a judgement of 'low' or 'high' risk of bias.
Adverse events
Incomplete outcome data High risk Comment: 33 participants were included in this study, and results are report-
(attrition bias) ed for all. However, the presented individual follow-up periods for the partici-
Re-dislocation, longest or pants show that beyond 6 months there were considerable, unexplained loss-
main follow-up es to follow-up, particularly at 2 years (62.5% in Group A and 35.3% in Group
B). No information is provided about the planned or applied approach to miss-
ing outcome data; however, it seems that no missing data were replaced.
Incomplete outcome data High risk Comment: see above.

(attrition bias)
Any instability
Incomplete outcome data High risk There was insufficient information. However, in view of the high number of
(attrition bias) losses to follow-up, risk of attrition bias was judged as high for this outcome,
Adverse events too.
Selective reporting (re- Unclear risk Comment: no study protocol is available. 2 of the key outcomes reported (re-
porting bias) dislocation and the apprehension test) were not specified as outcomes in the
Methods section, and it is unclear how data on re-dislocation and the 'intimi-
dation' (apprehension) test were obtained. No specific data on adherence are
presented. No usable outcome data was reported for the Rowe Score, and it
was not clear whether this outcome measure was patient-assessed, i.e. of rele-
vance to the review.
Other bias Unclear risk Comment: no information about funding was provided.

Whelan 2014
Methods Aim: "...to compare the (1) frequency of recurrent instability and (2) disease-specific quality-of-life
scores after treatment of first-time shoulder dislocation using either immobilization in external rotation
or immobilization in internal rotation in a group of young, North American patients." (p.2381)
Method of randomisation: computer-generated permuted block algorithm (stratified to study centre)
Assessor blinding: yes
Loss to follow-up: 10 (17%), comprising 5/31 (16%) in Group A and group 5/29 (17%) in Group B
Informed decisions.

Whelan 2014 (Continued)
Participants Setting: Emergency departments and outpatient orthopaedic and primary care clinics at 3 university
centres, Canada
Period of data collection: September 2003 to March 2008

Participants: 60
Inclusion criteria: skeletally mature patients younger than 35 years with a primary anterior gleno-
humeral dislocation diagnosed by radiography.
Exclusion criteria: history of previous instability in the affected shoulder; significant associated frac-
tures of the proximal humerus, glenoid or scapula (exceptions: Hill-Sachs lesions and/or small bony
Bankart lesions); patients unwilling or unable to participate
Sex: 55 male (92%)
Pre-injury status: 6/31 (19%) in Group A and 9/29 (31%) in Group B had signs of positive ligamentous
hypermobility
Assessed: 27/25 (at final follow-up) for re-dislocation and surgery (data for 2 participants who were lost
to follow-up was obtained from the next of kin); 26/24 for the other outcomes
Interventions Group A: immobilisation for 4 weeks with an external rotation shoulder brace, in 90° of elbow flexion,
0° of shoulder abduction and flexion and 0° to 5° of shoulder external rotation. All patients received an
identical brace (DonJoy; DJO, LLC, Vista, CA, USA), which was adjusted by a certified orthopaedic tech-
nician
Group B: immobilisation for 4 weeks with a traditional internal rotation sling, in 90° of elbow flexion, 0°
of shoulder abduction and flexion and 70° to 80° of shoulder internal rotation. All patients received an
identical sling (DonJoy; DJO, LLC), which was adjusted by a certified orthopaedic technician
Both groups: presumably, immobilisation started within 7 days after dislocation (patients were as-
sessed for eligibility within 7 days after dislocation). Patients were instructed to wear the braces or
slings at all times, except for brief periods of removal for showering and therapy. They were also pro-
vided with detailed written instructions including information about the appropriate use of the brace/
sling, and with contact details of the study coordinators. Patients' compliance with wearing their brace
or sling was encouraged through weekly telephone calls by the study coordinator
After the immobilisation period, all patients began a 16-week physical therapy programme which was
provided by outpatient or private practice therapists
Outcomes Follow-up assessments were reportedly conducted at 4 weeks and 3, 6, 12, 18 and 24 months post-dis-
location
Prespecified as primary outcome
Recurrent instability (primary outcome), "defined by a documented episode of anterior shoulder dis-
location ... with radiographic evidence of the same and/or requiring manipulative reduction in a con-
trolled hospital or healthcare setting or multiple episodes of shoulder subluxation, which, in the pa-
tient’s opinion, was disabling or symptomatic enough to warrant surgical stabilization. An assessment
by an orthopaedic surgeon was mandatory in the case of the recurrent subluxation before categorizing
these patients as having had an adverse event." (pp.2382-3). The results for this outcome are presented
subdivided into the following outcomes: recurrent dislocation;recurrent instability (comprising re-
current dislocations and subluxations); and recurrent instability requiring surgical stabilization
American Shoulder and Elbow Surgeons evaluation form (ASES) (not used in review)
Adherence: patients were asked to keep a diary of brace or sling wear (in which physical therapy atten-
dance was also recorded). Compliance was further formally assessed with a questionnaire (not further
specified) after the immobilisation period
Adverse events: complications; not further specified
Informed decisions.

Surgical intervention: surgery was considered based on the patient's opinion that the recurrent insta-
bility "was disabling or symptomatic enough to warrant surgical stabilisation" (p. 2383)
Notes The methods used for the reduction of the shoulder dislocation are not specified
Results are presented for "minimum 12 months' follow-up", but not for the different follow-up points
Relationship between this and previous reports:
Whelan 2008 was a conference abstract reporting preliminary results. There are discrepancies between
the study report and the registration record (Litchfield; NCT00196560) relating to the outcomes: name-
ly, time (weeks) to return to work and to return to sport is specified as an outcome in the registration
file, but is not mentioned in the study report
Funding and declarations of interest:
"This trial was funded by the Physicians Services Incorporated Foundation and the American Shoulder
and Elbow Surgeons Grant." Declarations of interests were not reported ("all ICMJE Conflict of Interest
Forms for authors [...] can be viewed on request [...]." (p.2380). This study was conducted at the Fowler
Kennedy Sport Medicine Clinic in London, Ontario, Canada, in conjunction with JOINTS Canada (Joint
Orthopaedic Initiative for National Trials on the Shoulder Canada)."
Risk of bias
Random sequence genera- Low risk Quote: “… patients … were randomly assigned (by computer-generated, per-
tion (selection bias) muted block algorithm) to one of two immobilization groups…” (p.2382). Ran-
domisation was stratified by study centre.
Allocation concealment Low risk Quote: “The randomization sequence was kept concealed by the use of
(selection bias) sealed opaque, sequentially numbered envelopes, which were opened on-
ly after inclusion criteria were satisfied and informed consent had been ob-
tained.” (p.2382).
mance bias)
All outcomes
Blinding of outcome as- Low risk Quote: "It [the trial] was single-blinded in that all evaluations were per-
sessment (detection bias) formed by independent evaluators who were unaware of treatment alloca-
Re-dislocation tion.” (p.2381). "...all [outcome] data were collected by a research coordinator
who was blinded to the patient’s intervention assignment." (p.2382).
Blinding of outcome as- High risk Comment: this outcome (WOSI) was subjective, i.e. patient-assessed, and thus
sessment (detection bias) inevitably unblinded. The review authors judge that it is likely that results may
Validated PROMs for have been influenced by lack of blinding (considering also that the partici-
shoulder instability pants were unblinded to their treatment allocation).
Blinding of outcome as- High risk Comment: subluxation was patient-assessed, and was hence inevitably un-
sessment (detection bias) blinded. The review authors judge that it is likely that results may have been
Any instability influenced by lack of blinding (considering also that the participants were un-
blinded to their treatment allocation).
Adverse events
Informed decisions.

Incomplete outcome data Unclear risk Comment: the flow of participants through the study is insufficiently reported
(attrition bias) and unclear. There is no information about whether all participants received
Re-dislocation, longest or the treatment they were allocated to. However, all outcomes were reportedly
main follow-up analysed on an intention-to-treat basis.
There is no information about the numbers of losses to follow-up at each spe-

cific follow-up time point. The proportion of losses reported for the "results at
minimum 12 months' follow-up" were fairly high, but were similar between the
groups (13% in Group A, 14% in Group B). No reasons are provided for the loss-
es to follow-up.
No information is provided about the planned or applied approach to miss-

ing outcome data; however, it seems that no missing data were replaced. The
review authors judge that there is insufficient information to permit a clear
judgement of ‘low’ or ‘high risk’.
The fact that data on recurrent dislocation was obtained in a different way
(from the next of kin) for 2 participants who were lost to follow-up is not con-
sidered as likely to have influenced the outcome.
Incomplete outcome data Unclear risk Comment: see above.

(attrition bias)
Validated PROMs for
Incomplete outcome data Unclear risk Comment: see above.

(attrition bias)
Any instability
Incomplete outcome data Unclear risk Comment: there is insufficient information to allow for a judgement of 'low
(attrition bias) risk' or 'high risk' of bias.
Adverse events
Selective reporting (re- Unclear risk Comment: the presentation of the results in relation to the different follow-up
porting bias) periods ("minimum 12 months' follow-up") is unexplained and unclear (were
participants excluded when they experienced re-dislocation?) and is judged
to raise the possibility of reporting bias as results may have differed across the
different follow-up time points. There are some discrepancies between the
study report and the registration record which, though, relate to outcomes
that were not of interest to this review (time (weeks) to return to work and to
return to sport; ROM, strength).
CT: Computed tomography

MRI: Magnetic resonance imaging
SD: Standard deviation
WOSI: Western Ontario Shoulder Instability Index

Characteristics of excluded studies [ordered by study ID]

Study Reason for exclusion
ACTRN12611001183976 This trial was abandoned: “Unfortunately due to the low participation rate and high drop out rate
we are no longer recruiting to the study. We do not intend to publish this research.” (personal com-
munication with the principal investigator, Timothy Walker, 4 June 2018)
Blanchard 2015 Not a trial: a summary of Hanchard 2014
Informed decisions.

Study Reason for exclusion
Chutkan 2012 Not a trial: a commentary on Liavaag 2011
Harper 2000 No response was received to requests for information on this trial, which is listed in the National
Research Register UK. We found no other reports of this trial
Hovelius 1983 This trial involved 27 centres. At 6 centres, allocation to 2 different durations of immobilisation was
based on date of shoulder dislocation. At the other 21 centres, treatment was given according to
customary practice. Hence, overall this study was neither randomised nor quasi-randomised
Hutchinson 2013 Not a trial: a book review
Itoi 2003 We have received contradictory information on the status of this preliminary quasi-randomised
study in relation to Itoi 2007. Excluded to remove the risk of duplicate populations
Itoi 2015 Not an RCT or quasi-RCT; no interventions or outcomes of relevance to the review question. In this
study, which is labelled a “controlled laboratory study”, patients were assessed by MRI immediately
after they consented to participate (after presenting with an initial traumatic anterior shoulder dis-
location), and 4 different shoulder positions were assessed by MRI to investigate the (immediate)
effect of these positions on the reduction of a Bankart lesion.
Kiviluoto 1980 Of 99 people younger than 50 years in this study, 53 were immobilised for 1 week and 46 for 3
weeks. However, no indication reveals the method of allocation to the 2 groups, nor are results pre-
sented for these participants. We received no response from the study authors
Königshausen 2014 Not an RCT or quasi-RCT: a prospective cohort study of 28 patients with primary traumatic anteri-
or shoulder dislocation, "to investigate the recurrence and instability rates of patients 5 years after
primary traumatic anterior shoulder dislocation treated with an external rotation brace..."
Lacy 2015 Not an RCT or quasi-RCT: a study reporting on the development of a “low-cost” shoulder brace.
McCarty 2014 Not a trial: a commentary on Whelan 2014
Momenzadeh 2015 An RCT, in which none of our pre-specified outcomes of interest for the review question were as-
sessed. 20 patients with primary anterior shoulder dislocation were randomised to immobilisation
in external or internal rotation. After 3 weeks, various radiographic parameters (displacement, sep-
aration and opening angle) were assessed by magnetic resonance arthrography to determine the
effect of the shoulder immobilisation position on the coaptation of a Bankart lesion.
Staply 2002 A contact person at the institution given for this trial as listed in the National Research Register UK
indicated that this trial did not appear to have been started. We found no other reports of this trial
Wakefield 2001 A draft report of this pilot study of 23 participants, comparing Intensive physiotherapy plus home
exercises versus home exercises alone, was shared with review authors in June 2005. At that time, a
report was expected to be submitted shortly for publication. We are unable to find a published ver-
sion of the report, and the contact author is no longer available at the postal or email address given
in the trial registry
Whelan 2010 Not a trial: a commentary on Finestone 2009
Xu 2003 This was not a randomised controlled trial but a comparison, with a historical control group, of sys-
tematic rehabilitation therapy versus supporting bandage in 43 people with acute shoulder dislo-
cation
ASES: American Shoulder and Elbow Surgeons

HRQoL: Health-related quality of life
ISRCTN: International Standard Randomised Controlled Trial Number Register
Informed decisions.

MRI: Magnetic Resonance Imaging


Characteristics of studies awaiting assessment [ordered by study ID]

ISRCTN41070054
Methods Reportedly a randomised controlled trial
Participants 38 people with anterior shoulder dislocation
Interventions 1. External rotation splint
2. Sling
Outcomes Follow-up: not stated
Incidence of recurrent dislocation
Notes The anticipated end date of this UK-based study, which is listed as completed on the ISRCTN reg-
istry, was 1 November 2010. We are unable to find a published report, and we received no response
to our email and postal correspondence to the contact author, Mr N Nicolaou

ISRCTN48254181
Methods Stated to be a randomised controlled trial
Participants 150 people with primary anterior shoulder dislocation
Interventions 1. Arm immobilised in external rotation

2. Arm immobilised in internal rotation
Outcomes Follow-up: not stated

Recurrence
Notes The anticipated end date of this UK-based study, which is listed as completed on the ISRCTN reg-
istry, was 1 May 2008. We are unable to find a published report, and we received no response to our
email and postal correspondence to the contact author, Mr A Pimpalnerkar

Itoi 2013
Methods Randomised controlled trial
Participants 109 people with primary traumatic shoulder dislocation. Study conducted in Japan
Interventions 3 weeks' immobilisation in external rotation followed by:
1. no shoulder motion restriction band;
2. a shoulder motion restriction band for 3 weeks; or
3. a shoulder motion restriction band for 6 weeks.
Outcomes Recurrent dislocation and return to sports, assessed at 2-year follow-up
Notes No difference in recurrence rate was reported
Informed decisions.

'Awaiting classification' as evaluating a supplement to an immobilisation technique whose general
effectiveness is not established

Miller 2007
Methods Method of randomisation: randomised multi-centre ‒ no details
Participants 30 people (to date) 18 to 30 years of age with acute, first-time anterior dislocation of the shoulder.
Study conducted in USA
Interventions 3 weeks' immobilisation in:
1. a 15° external rotation brace; or
2. a sling.
This was followed by an identical short course of physiotherapy
Outcomes Follow-up: 1 year
WOSI, subjective portion of ASES shoulder assessment form and a study-specific questionnaire
Notes Interim results reported in a 2007 poster presentation. We received no response to our attempt to
contact Dr BS Miller

Murray 2016
Methods Randomised controlled trial
Participants 50 people with primary traumatic anterior dislocation of the shoulder. Study conducted in Canada.
Interventions 3 weeks' immobilisation in:
1. external rotation; or
2. internal rotation
No further information is provided.
Outcomes Follow-up: 2 years
Primary: recurrent dislocation
Secondary: healing rate of labral lesion, if present (diagnosed by MRI)
Notes This study is as yet only reported in a conference abstract. We received the following response to
our enquiry on the availability of a full report of this study from the corresponding author of the ab-
stract, Dr Murray (personal communication by email, 31 May 2018): "We are actively trying to pub-
lish the manuscript but so far unsuccessfully. So it’s only a conference abstract for now."

NCT00707018
Methods Method of randomisation: initially quasi-randomised using alternation (10 cases), then use of ran-
dom numbers chart
Informed decisions.

NCT00707018 (Continued)
Loss to follow-up: not known
Participants 50 people 14 to 30 years of age with acute, first-time, traumatic, isolated anterior dislocation of the
shoulder (no significant fractures)
Interventions 1. External rotation shoulder sling
2. Internal rotation shoulder sling
Outcomes Follow-up: 2 years
Primary: recurrent instability consisting of a documented episode of anterior shoulder dislocation

or multiple episodes of shoulder subluxation
Secondary: participant self-reported outcome measures, time to return to work or sport
Notes This USA-based study is listed as completed on the ISRCTN registry, with an end date of 1 February
2012. We are unable to find a published report, and we received no response to our attempt to con-
tact Prof EC McCarty

Characteristics of ongoing studies [ordered by study ID]

ACTRN12616001241426
Trial name or title An RCT assessing the efficacy of smart phone apps in the conservative management of shoulder re-
habilitation post dislocation in the male and female population between 15 to 60 years of age (reg-
istered scientific title)
Methods Randomised controlled trial; Australia and New Zealand
Participants Males and females (age 15 to 60 years) with radiologically or clinically diagnosed anterior disloca-
tion of a shoulder (target sample size = 48)
Interventions 1. Access to a smartphone application including information (related to the injury, management
and prognosis) and a staged exercise-based rehabilitation programme as an adjunct to a super-
vised (physiotherapy) rehabilitation programme
2. Supervised rehabilitation (same as for the intervention group) without access to the smartphone
application.
Outcomes Follow-up: 18 months (final follow-up)
Outcomes: Oxford Shoulder Instability Score (OSIS); need for surgery; compliance with rehabilita-
tion, "helpfulness" of the smartphone application
Starting date See notes
Contact information Principal investigator: Dr Nicholas Noye; nicholasnoye@gmail.com
Notes The trial registration record was last updated in October 2017 (last accessed 2 August 2018). Re-
cruitment for this study has not yet started ‒ we received the following response from the principal
investigator, Dr Nicholas Noye, on our enquiry about the current status of the study: "... the study
has been delayed. I now plan to start the trial here in Waikato NZ beginning next year and will not
be commencing the Australian study until at least 2019..." (personal communication, by email, 25
May 2018). Dr Noye also sent us the (unpublished) protocol for the study. The information provided
here is largely based on information provided in the protocol.
Informed decisions.


ARTISAN
Trial name or title Acute Rehabilitation following Traumatic anterior shoulder dISlocAtioN (ARTISAN) - A Multi Centre
RCT
Methods Randomised controlled trial, multi-centre; target sample size 478 (main study, proceeded by an in-
ternal pilot on a target sample of 50 participants); UK
Participants People (≥ 18) with first-time traumatic anterior shoulder dislocation
Interventions Treatment includes up to 2 weeks of immobilisation (with intervention within 6 weeks post-injury)
1. Single session (up to 1 hour) of "advice to aid self-management" (including education on the in-
jury, on complications and how to prevent pain; discussion exercises; use of different media)
2. Same session as 1., followed by a course of individually tailored physiotherapy (minimum of 2

sessions offered) for up to 30 minutes, over 4 months.
Outcomes Follow-up: 12 months (final follow-up)
Primary: Oxford Shoulder Instability Score (OSIS) (after 6 months)
Secondary: functional outcome (Quick-DASH), quality of life (EQ-5D-5L), complications, resource

use
Starting date Duration of study specified as from 1 June 2018 to 30 November 2021
Contact information Chief Investigator: Ass Prof Rebecca Kearney

Warwick Clinical Trials
The University of Warwick
Gibbet Hill Road
Coventry, CV4 7AL
Tel: 02476573156
Email: r.s.kearney@warwick.ac.uk
Notes An NIHR-funded HTA project, which was incidentally found during other searches. The project has
obviously only just been started.

Eshoj 2017
Trial name or title A neuromuscular exercise programme versus standard care for patients with
traumatic anterior shoulder instability (the SINEX study)
Methods Randomised controlled trial; target sample size 80 but number of actually enrolled participants
was 56; Denmark
Participants Patients (male or female, age 18 to 39 years) with primary or recurrent anterior shoulder disloca-
tion
Interventions 1. "SINEX programme": individual physiotherapist-supervised neuromuscular shoulder exercise

programme (12 weeks)
2. Self-managed shoulder exercise programme with 1 introductory supervised physiotherapy ses-

sion (12 weeks)
Outcomes 104 weeks (final follow-up)
Informed decisions.

Eshoj 2017 (Continued)
Primary: change in WOSI (after 12 weeks)
Secondary: WOSI subdomains, kinesiophobia (Tampa Scale of Kinesiophobia), quality of life

(EQ-5D-5L), pain, self-reported shoulder function (Patient-Specific Functioning Scale (PSFS), CMS),
clinical shoulder instability (e.g. apprehension test), shoulder proprioception (e.g. joint reposition-
ing), re-dislocation/subluxation, medication use, satisfaction with treatment, adverse events.
Starting date February 2015
Contact information Principal investigator: Henrik Eshoj: heshoj@health.sdu.dk
Notes According to the trial registration record (NCT02371928; most recent update posted: March 2018;
(last accessed 2 August 2018)), recruitment is completed (actual study completion date: June
2017). We tried to contact the principal investigator, Mr Henrik Eshoj, in May 2018 to enquire about
the current status of the study and its anticipated publication, but have not received a response.
The information presented here was mainly taken from the published protocol.

NCT01648335
Trial name or title A prospective study of the effect of treatment of first-time traumatic shoulder anterior dislocation
by immobilization in external rotation on the incidence of recurrent dislocation
Methods Parallel assignment; intended sample size not reported
Participants Males 18 to 29 years of age with first-time dislocation of the shoulder
Interventions 1. Immobilisation in internal rotation in a universal shoulder immobiliser
2. Immobilisation in external rotation in a universal shoulder immobiliser
Outcomes Follow-up: 6 months after dislocation
Primary: number of recurrent dislocations
Secondary: range of motion; supine apprehension test
Starting date June 2012
Contact information None given
Notes The recruitment status of this study is 'unknown' (ClinicalTrials.gov, last update posted in March
2013) and it may have been abandoned. No corresponding author details were available for this
study. We attempted to make contact through the responsible organisation (Hadassah Medical Or-
ganization, Israel), but did not receive a response.

NCT02197819
Trial name or title A Randomized Evaluation of Emergent Immobilization in External Rotation in the Management of
Acute Anterior Dislocations of the Shoulder (EERAADS)
Methods Randomised controlled trial; target sample size 75; Canada
Participants Patients (age 18 to 35 years) following reduction of a first-time traumatic anterior shoulder disloca-
tion
Informed decisions.

NCT02197819 (Continued)
Interventions 1. Immobilisation in an external rotation brace for 4 weeks (start < 4 hours post-reduction)
2. Immobilisation in a traditional internal rotation sling (start < 4 hours post-reduction)
Outcomes Follow-ups: 12 months (no further follow-up points specified)
Primary: re-dislocation (within 12 months)
Secondary: none specified
Starting date February 2013 (study start date)
Contact information contact: Dr Ryan M Khan; khanry@smh.ca (principal investigator: Dr Daniel B Welan)
Notes According to the registration record (most recent update posted: August 2017 (last accessed 2 Au-
gust 2018)), the trial is still recruiting. The estimated primary completion date specified as February
2018; the estimated study completion date as February 2019. We tried to contact Dr Khan in May
2018 to enquire about the current status of the study but have not received a response.
3 different age ranges for eligibility are provided within the registration record: 16 to 30; 18 to 40; 18
to 35 years.
ACTRN: Australian New Zealand Clinical Trials Registry

CMS: Constant-Murley Score
DASH: Disabilities of the Arm, Shoulder, and Hand
EQ (-5D-5L): EuroQual (-5D-5L)
NCT: National Clinical Trial

DATA AND ANALYSES

Comparison 1. Immobilisation in external versus internal rotation
Outcome or subgroup title No. of No. of Statistical method Effect size

studies partici-
pants
1 Re-dislocation at ≥ 12 months fol- 6 488 Risk Ratio (M-H, Random, 95% CI) 0.67 [0.38, 1.19]
low-up (nearest to 24 months accepted)
2 Re-dislocation data at last follow-up Other data No numeric data
3 Re-dislocation, interim follow-ups (3 1 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected
and 12 months)
3.1 Re-dislocation, 12 months follow-up 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
3.2 Re-dislocation, 3 months follow-up 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
4 Re-dislocation: stratified according to 6 Risk Ratio (M-H, Random, 95% CI) Subtotals only
external rotation with / without abduc-
tion
4.1 External rotation without abduction 4 320 Risk Ratio (M-H, Random, 95% CI) 0.94 [0.61, 1.44]
Informed decisions.

Outcome or subgroup title No. of No. of Statistical method Effect size

studies partici-
pants
4.2 External rotation with abduction 2 168 Risk Ratio (M-H, Random, 95% CI) 0.33 [0.04, 2.46]
5 Validated patient-reported outcome 2 Mean Difference (IV, Fixed, 95% CI) Totals not selected
measures for shoulder disability (OSI,
WOSI)
5.1 WOSI at 33 months follow-up (total 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
score)
5.2 WOSI at mean 25 months follow-up 1 Mean Difference (IV, Fixed, 95% CI) 0.0 [0.0, 0.0]
6 Validated PROMS: non-parametric re- Other data No numeric data

sults
6.1 Final follow-up Other data No numeric data
6.2 Interim follow-up Other data No numeric data
7 Resumption of pre-injury activities 3 Risk Ratio (M-H, Fixed, 95% CI) Totals not selected
7.1 Return to pre-injury sports at 24 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
months
7.2 Return to sports at any level at 24 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
months
7.3 Return to pre-injury sports activity 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
level at 24 months
7.4 Return to pre-injury level of activity 1 Risk Ratio (M-H, Fixed, 95% CI) 0.0 [0.0, 0.0]
of affected arm at ≥ 24 months
8 Any instability (subluxation or subjec- 5 Risk Ratio (M-H, Random, 95% CI) Subtotals only
tive instability, individually or grouped
into composite outcome)
8.1 Recurrent instability 3 395 Risk Ratio (M-H, Random, 95% CI) 0.84 [0.62, 1.14]
8.2 Positive apprehension test or re-dis- 2 135 Risk Ratio (M-H, Random, 95% CI) 0.28 [0.14, 0.57]
location
9 Adverse events 7 Risk Ratio (M-H, Fixed, 95% CI) Subtotals only
9.1 Transient and resolved adverse 4 377 Risk Ratio (M-H, Fixed, 95% CI) 2.73 [0.83, 9.02]
events
9.2 Important adverse events 3 268 Risk Ratio (M-H, Fixed, 95% CI) 0.61 [0.08, 4.46]
10 Adherence to treatment 6 Risk Ratio (M-H, Random, 95% CI) Totals not selected
11 Subsequent surgery 4 327 Risk Ratio (M-H, Fixed, 95% CI) 0.76 [0.44, 1.30]

Informed decisions.

Analysis 1.1. Comparison 1 Immobilisation in external versus internal rotation,

Outcome 1 Re-dislocation at ≥ 12 months follow-up (nearest to 24 months accepted).
Study or subgroup External Internal Risk Ratio Weight Risk Ratio
rotation rotation
n/N n/N M-H, Random, 95% CI M-H, Random, 95% CI
Chan 2018 8/33 10/33 19.21% 0.8[0.36,1.77]
Finestone 2009 10/27 10/24 21.26% 0.89[0.45,1.76]
Heidari 2014 2/51 17/51 10.7% 0.12[0.03,0.48]
Liavaag 2011 28/91 23/93 25.26% 1.24[0.78,1.99]
Taskoparan 2010 1/16 5/17 6.3% 0.21[0.03,1.63]
Whelan 2014 6/27 8/25 17.27% 0.69[0.28,1.72]

Total (95% CI) 245 243 100% 0.67[0.38,1.19]
Total events: 55 (External rotation), 73 (Internal rotation)
Heterogeneity: Tau2=0.28; Chi2=12.95, df=5(P=0.02); I2=61.4%
Test for overall effect: Z=1.37(P=0.17)
Favours external rotation 0.01 0.1 1 10 100 Favours internal rotation

Analysis 1.2. Comparison 1 Immobilisation in external versus
internal rotation, Outcome 2 Re-dislocation data at last follow-up.
Re-dislocation data at last follow-up
Study Follow-up External rotation, n Internal rotation,n
events/n group (%) events/n group (%)
Chan 2018 24 months ("full period") 8/33 (24%) 10/33 (30%)
Finestone 2009 Mean 33.4 (range 24 to 48) months 10/27 (37%) 10/24 (42%)
Heidari 2014 24 months 2/51 (4%)
Liavaag 2011 Minimum 2 years, mean 29.1 (range 28/91 (31%) 23/93 (25%)
24-54) months
Taskoparan 2010 Mean 21 (range 6 to 41) months 1/16 (6%) 5/17 (29%)
Whelan 2014 Minimum 12 months, mean 25 (range 6/27 (22%)
12-43) months

Analysis 1.3. Comparison 1 Immobilisation in external versus internal
rotation, Outcome 3 Re-dislocation, interim follow-ups (3 and 12 months).
Study or subgroup External rotation Internal rotation Risk Ratio Risk Ratio
n/N n/N M-H, Fixed, 95% CI M-H, Fixed, 95% CI
1.3.1 Re-dislocation, 12 months follow-up
Chan 2018 8/31 7/24 0.88[0.37,2.1]

1.3.2 Re-dislocation, 3 months follow-up
Chan 2018 1/34 0/28 2.49[0.11,58.74]

Informed decisions.

Analysis 1.4. Comparison 1 Immobilisation in external versus internal rotation, Outcome

4 Re-dislocation: stratified according to external rotation with / without abduction.
rotation rotation
1.4.1 External rotation without abduction
Finestone 2009 10/27 10/24 29.28% 0.89[0.45,1.76]
Liavaag 2011 28/91 23/93 47.69% 1.24[0.78,1.99]
Taskoparan 2010 1/16 5/17 4.31% 0.21[0.03,1.63]
Whelan 2014 6/27 8/25 18.71% 0.69[0.28,1.72]
Subtotal (95% CI) 161 159 100% 0.94[0.61,1.44]

1.4.2 External rotation with abduction
Chan 2018 8/33 10/33 54.23% 0.8[0.36,1.77]
Heidari 2014 2/51 17/51 45.77% 0.12[0.03,0.48]
Subtotal (95% CI) 84 84 100% 0.33[0.04,2.46]
Test for subgroup differences: Chi2=0.98, df=1 (P=0.32), I2=0%

Analysis 1.5. Comparison 1 Immobilisation in external versus internal rotation, Outcome
5 Validated patient-reported outcome measures for shoulder disability (OSI, WOSI).
Study or subgroup External rotation Internal rotation Mean Difference Mean Difference
N Mean(SD) N Mean(SD) Fixed, 95% CI Fixed, 95% CI
1.5.1 WOSI at 33 months follow-up (total score)
Heidari 2014 48 187.7 (67.5) 49 230.9 (78.8) -43.2[-72.38,-14.02]

1.5.2 WOSI at mean 25 months follow-up
Whelan 2014 27 -87 (14) 25 -84 (21) -3[-12.78,6.78]
Favours external rotation -100 -50 0 50 100 Favours internal rotation

Analysis 1.6. Comparison 1 Immobilisation in external versus internal
rotation, Outcome 6 Validated PROMS: non-parametric results.
Validated PROMS: non-parametric results
Study Follow-up Measure External rotation Internal rotation Reported P
Final follow-up
Chan 2018 24 months OSI (0 to 48: least impair- median 43.5 (range 12 to median 43.5 (range 13 to P = 0.50
ment) 48); n = 30 48); n = 27
Liavaag 2011 mean 29 months (24 to WOSI (0 to 2100: worst median 238 (interquar- median 375 (interquar- P = 0.32
54) disability) tile range 101 to 707); n tile range 135 to 719); n
= 86 = 88
Interim follow-up
Chan 2018 12 months OSI (0 to 48: least impair- median 43 (range 6 to median 42.5 (range 5 to P = 0.35
ment) 48); n = 30 48); n = 24
Informed decisions.


Analysis 1.7. Comparison 1 Immobilisation in external versus
internal rotation, Outcome 7 Resumption of pre-injury activities.
1.7.1 Return to pre-injury sports at 24 months
Heidari 2014 26/31 12/38 2.66[1.62,4.35]

1.7.2 Return to sports at any level at 24 months
Itoi 2007 43/60 31/49 1.13[0.87,1.48]

1.7.3 Return to pre-injury sports activity level at 24 months
Itoi 2007 22/60 10/49 1.8[0.94,3.43]

1.7.4 Return to pre-injury level of activity of affected arm at ≥ 24 months
Liavaag 2011 51/83 52/86 1.02[0.8,1.29]
Favours internal rotation 0.01 0.1 1 10 100 Favours external rotation

Analysis 1.8. Comparison 1 Immobilisation in external versus internal rotation, Outcome 8 Any
instability (subluxation or subjective instability, individually or grouped into composite outcome).
rotation rotation
1.8.1 Recurrent instability
Itoi 2007 22/85 31/74 31.68% 0.62[0.39,0.97]
Liavaag 2011 45/93 45/91 51.85% 0.98[0.73,1.31]
Whelan 2014 10/27 10/25 16.47% 0.93[0.47,1.84]
Subtotal (95% CI) 205 190 100% 0.84[0.62,1.14]

1.8.2 Positive apprehension test or re-dislocation
Heidari 2014 6/51 23/51 76.14% 0.26[0.12,0.59]
Taskoparan 2010 2/16 6/17 23.86% 0.35[0.08,1.51]
Subtotal (95% CI) 67 68 100% 0.28[0.14,0.57]
Heterogeneity: Tau2=0; Chi2=0.13, df=1(P=0.72); I2=0%
Test for overall effect: Z=3.52(P=0)

Analysis 1.9. Comparison 1 Immobilisation in external versus internal rotation, Outcome 9 Adverse events.
rotation rotation
1.9.1 Transient and resolved adverse events
Informed decisions.


rotation rotation
Chan 2018 0/33 0/32 Not estimable
Finestone 2009 0/27 2/24 71.86% 0.18[0.01,3.54]
Heidari 2014 3/51 0/51 13.6% 7[0.37,132.17]
Itoi 2007 6/85 0/74 14.53% 11.34[0.65,197.91]
Subtotal (95% CI) 196 181 100% 2.73[0.83,9.02]
Heterogeneity: Tau2=0; Chi2=4.55, df=2(P=0.1); I2=56.01%

1.9.2 Important adverse events
Liavaag 2011 1/91 1/93 39.74% 1.02[0.06,16.09]
Taskoparan 2010 0/16 1/16 60.26% 0.33[0.01,7.62]
Whelan 2014 0/27 0/25 Not estimable
Subtotal (95% CI) 134 134 100% 0.61[0.08,4.46]
Test for subgroup differences: Chi2=1.61, df=1 (P=0.21), I2=37.73%

Analysis 1.10. Comparison 1 Immobilisation in external
versus internal rotation, Outcome 10 Adherence to treatment.
Chan 2018 18/34 16/28 0.93[0.59,1.45]
Finestone 2009 26/27 24/24 0.97[0.87,1.07]
Heidari 2014 41/51 48/51 0.85[0.73,0.99]
Itoi 2007 61/85 39/74 1.36[1.06,1.75]
Liavaag 2011 63/93 45/95 1.43[1.11,1.84]
Whelan 2014 27/31 24/29 1.05[0.85,1.3]
Favours internal rotation 0.5 0.7 1 1.5 2 Favours external rotation

Analysis 1.11. Comparison 1 Immobilisation in external versus internal rotation, Outcome 11 Subsequent surgery.
rotation rotation
Chan 2018 4/33 4/32 16.12% 0.97[0.26,3.55]
Finestone 2009 2/27 4/24 16.81% 0.44[0.09,2.21]
Itoi 2007 8/85 9/74 38.2% 0.77[0.31,1.9]
Whelan 2014 6/27 7/25 28.86% 0.79[0.31,2.04]

Total (95% CI) 172 155 100% 0.76[0.44,1.3]
Informed decisions.


rotation rotation

ADDITIONAL TABLES

Table 1. Key characteristics of the immobilisation treatment
Study Start of im- Duration External Type of braces and slings Providers
mobilisation of immo- rotation
(post-disloca- bilisation position
tion)
Chan 2018 within 5 days 4 weeks 30° + 30° external rotation brace: Smartsling, Ossur, Reykjavik, Ice- appro-
abduction land); priately
trained
internal rotation sling: Polysling, Mölnlycke Health Care, members
Gothenburg, Sweden) of staff
(surgeons,
nurses or
health-
care assis-
tants)
Finestone no information 4 weeks 15° to 20° external rotation brace: (manufacturer unspecified); unclear
2009
internal rotation sling:
traditional internal rotation sling
Heidari presumably on 3 weeks 10° + 15° external rotation brace: unclear

2014 the same day abduction
(patients pre- stabiliser brace with adjustable angle of abduction (body:
sented within 6 hard polyethylene); presumably commercially manufac-
hours) tured but purpose-designed;
sling and swathe bandage
Itoi 2007 within 2 days 3 weeks 10° external rotation brace: the treat-
(termed ing sur-
a) wire-mesh splint covered with sponge and a stockinette geons
day 1 to 3) (until October 2003);
b) prototype brace, Alcare, Tokyo, Japan (from November

2003);
sling and swathe
Liavaag within 24 hours 3 weeks 15° external rotation brace: unclear

2011
15° UltraSling ER; DonJoy, Vista, California);
Informed decisions.

Table 1. Key characteristics of the immobilisation treatment (Continued)

internal rotation sling: normal collar and cuff device or
sling and swathe
Taskoparan on the same 3 weeks 10° external rotation brace: unclear

2010 day
"specific splint fixated in 10 degrees external rotation and
adduction" (polyethylene/thermoplastic);
1st day: "valpaeu bandaging"; from 2nd day: "waist-assist-

ed sling"
Whelan presumably 4 weeks 0° to 5° external rotation brace: certi-

2014 within 7 days fied or-
DonJoy (Vista, California) external rotation shoulder brace; thopaedic
(patients were techni-
assessed within internal rotation sling:
cians
7 days)
traditional internal rotation sling

Table 2. Lengths of follow-up in the included studies
Study Final follow-up Comments on follow-up
Chan 2018 24 months Set follow-up times: 3 months; 1 & 2 years post-dislocation
Finestone 2009 mean 33.4 months Set follow-up times: 2 & 6 weeks; 3 & 6 months; 1, 2, 3 & 4 years post-injury
(range 24 to 48)
Heidari 2014 24 months and 33 Set follow-up times; 3 weeks post-intervention; 24 months post-dislocation (re-dislo-
months cation);
33 months post-dislocation (WOSI only)
Itoi 2007 mean 25.6 months Set follow-up times: 6 months; 1 & 2 years (presumably post-initiation of immobilisa-
(range 24 to 30) tion)
Liavaag 2011 mean 29.1 months Set follow-up times: 3 weeks (adherence data); 2 years post-dislocation.
(range 24 to 54)
Taskoparan 2010 mean 21 months Set follow-up times: 6 months (function scores); 1 & 2 years (radiographs and MRI)
(range 6 to 41) Not specified for re-dislocation and adverse events
Individual patient data presented with follow-up ranging from 6 to 41 months
Whelan 2014 mean 25 months Set follow-up times: 4 weeks and 3, 6, 12, 18 & 24 months post-dislocation.
(range 12 to 43)
However, results were presented for a minimum of 12 months

Table 3. Re-dislocation: data for different age categories
Subgroup Study Age category External rotation group Internal rotation group
Data available for planned subgroup analysis age ≤ 20 years versus age ≥ 21 years
Informed decisions.

Table 3. Re-dislocation: data for different age categories (Continued)

age ≤ 20 Heidari 2014 ≤ 20 years 0/0 (0%) 0/0 (0%)
years
Taskoparan 2010 ≤ 20 years 0/0 (0%) 0/1 (0%)
age ≥ 21 Heidari 2014 ≥ 21 years 2/51 (4%) 17/51 (33%)

years
Taskoparan 2010 ≥ 21 years 1/16 (6%) 5/16 (31%)
Data available for planned subgroup analysis age ≤ 39 years versus age ≥ 40 years
age ≤ 39 Heidari 2014 ≤ 40 years 2/42 (5%) 16/47 (34%)

years
Liavaag 2011 ≤ 40 years 28/91 (31%) 23/93 (25%)
Whelan 2014 ≤ 35 years 6/27 (22%) 8/25 (32%)
age ≥ 40 Heidari 2014 ≥ 41 years 0/9 (0%) 1/4 (25%)

years
Other data, including subgroups
Other Chan 2018 16 to 44 years 8/33 (24%) 10/33 (30%)
Finestone 2009 17 to 27 years 19/27 (37%) 10/24 (42%)
Heidari 2014 21 to 30 years 1/16 (6%) 3/18 (17%)
Heidari 2014 31 to 40 years 1/26 4%) 13/29 (45%)
Liavaag 2011 16 to 22 years 19/33 (58%) 13/30 (43%)
Liavaag 2011 23 to 29 years 6/24 (25%) 7/27 (26%)
Liavaag 2011 30 to 40 years 3/34 (9%) 3/36 (8%)
Taskoparan 2010 15 to 75 years individual participant data in study report
The table shows age-related subgroup data for the predefined categories of interest (≤ 20 years versus ≥ 21 years; ≤ 39 years versus ≥ 40
years), as well as other subgroups or age ranges as reported in the trials. Actual thresholds varied as shown.

Table 4. Any instability: data for different age categories from Itoi 2007
Subgroup (age) External rotation group Internal rotation group
≤ 20 years 11/27 (41%) 13/19 (68%)
≥ 21 years 11/58 (19%) 18/55 (33%)
Informed decisions.

Table 4. Any instability: data for different age categories from Itoi 2007 (Continued)
≤ 40 years 19/62 (31%) 27/50 (52%)
≤ 41 years 3/23 (13%) 4/24 (17%)
The table shows age-related subgroup data for the predefined categories of interest (≤ 20 years, ≥ 21 years, ≤ 39 years, ≥ 40 years)

APPENDICES
Appendix 1. Search strategies (2013 to present)

Cochrane CENTRAL (CRS Online)
1 MESH DESCRIPTOR Shoulder Dislocation EXPLODE ALL AND CENTRAL: TARGET
2 (shoulder* AND (dislocat* or sublux* or instability or unstable)):TI,AB,KY AND CENTRAL: TARGET
3 (glenohumeral AND (joint or instability or unstable)):TI,AB,KY AND CENTRAL: TARGET
4 (lesion* AND (Hill Sachs or Bankart)):TI,AB,KY AND CENTRAL: TARGET
5 1 or 2 or 3 or 4
6 (immobilis* or immobiliz* or sling* or conservativ* or therap* or physiother* or rehabilitat* or mobilis* or mobiliz* or train* or exercis*
or (physical AND therap*)): AB,KW.TI AND CENTRAL: TARGET
7 MESH DESCRIPTOR Exercise AND CENTRAL: TARGET
8 MESH DESCRIPTOR Exercise Therapy EXPLODE ALL AND CENTRAL: TARGET
9 MESH DESCRIPTOR REHABILITATION EXPLODE ALL AND CENTRAL: TARGET
10 MESH DESCRIPTOR Physical Therapy Modalities AND CENTRAL: TARGET
11 MESH DESCRIPTOR IMMOBILIZATION EXPLODE ALL AND CENTRAL: TARGET
12 6 or 7 or 8 or 9 or 10 or 11
13 5 and 12
14 01/09/2013_TO_21/05/2018: CRSCREATED AND CENTRAL: TARGET
15 13 AND 14
MEDLINE (Ovid Web)

Ovid MEDLINE(R) Epub Ahead of Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE(R) Daily, Ovid MEDLINE and Versions(R)
1 Shoulder Dislocation/
2 (shoulder$ adj3 (dislocat$ or sublux$ or instability or unstable)).tw.
3 (glenohumeral adj (joint or instability or unstable)).tw.
4 (lesion$1 adj (Hill Sachs or Bankart)).tw.
5 1 or 2 or 3 or 4
6 (immobilis$ or immobiliz$ or sling$ or conservativ$ or therap$ or physiother$ or rehabilitat$ or mobilis$ or mobiliz$ or train$ or exercis
$ or physical therap$).tw.
7 Exercise/ or exp Exercise Therapy/ or exp REHABILITATION/ or Physical Therapy Modalities/ or exp IMMOBILIZATION/
8 (rh or th).fs.
9 6 or 7 or 8
10 5 and 9
11 randomized controlled trial.pt.
12 controlled clinical trial.pt.
13 randomized.ab.
14 placebo.ab.
15 drug therapy.fs.
16 randomly.ab.
17 trial.ab.
18 groups.ab.
19 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18
20 exp Animals/ not Humans.sh.
21 19 not 20
22 10 and 21
23 (201309* or 201310* or 201311* or 201312* or 2014* or 2015* or 2016* or 2017* or 2018*).ed,dt.
24 22 and 23
Informed decisions.

Embase (Ovid Web)

1 Shoulder Dislocation/ or Bankart Lesion/
2 (shoulder$ adj3 (dislocat$ or sublux$ or instability or unstable)).tw.
3 (glenohumeral adj (joint or instability or unstable)).tw.
4 (lesion$1 adj (Hill Sachs or Bankart)).tw.
5 1 or 2 or 3 or 4
6 (immobilis$ or immobiliz$ or sling$ or conservativ$ or therap$ or physiother$ or rehabilitat$ or mobilis$ or mobiliz$ or train$ or exercis
$ or physical therap$).tw.
7 (rh or th).fs.
8 Conservative Treatment/ or Physiotherapy/ or exp Exercise/ or Rehabilitation/ or exp immobilization/
9 6 or 7 or 8
10 5 and 9
11 exp Randomized Controlled Trial/
12 exp Double Blind Procedure/
13 exp Single Blind Procedure/
14 exp Crossover Procedure/
15 Controlled Study/
16 11 or 12 or 13 or 14 or 15
17 ((clinical or controlled or comparative or placebo or prospective$ or randomi#ed) adj3 (trial or study)).tw.
18 (random$ adj7 (allocat$ or allot$ or assign$ or basis$ or divid$ or order$)).tw.
19 ((singl$ or doubl$ or trebl$ or tripl$) adj7 (blind$ or mask$)).tw.
20 (cross?over$ or (cross adj1 over$)).tw.
21 ((allocat$ or allot$ or assign$ or divid$) adj3 (condition$ or experiment$ or intervention$ or treatment$ or therap$ or control$ or group
$)).tw.
22 17 or 18 or 19 or 20 or 21
23 16 or 22
24 limit 23 to human
25 10 and 24
26 (201309* or 201310* or 201311* or 201312* or 2014* or 2015* or 2016* or 2017* or 2018*).dc.
27 25 and 26
CINAHL (EBSCO)
S1 (MH "Shoulder Dislocation")
S2 TI ( (shoulder N3 dislocat*) or (shoulder N3 sublux*) or (shoulder N3 instability) or (shoulder N3 unstable) ) OR AB ( (glenohumeral N3
joint) or (glenohumeral N3 instability) or (glenohumeral N3 unstable) )
S3 TI ( (glenohumeral N3 joint) or (glenohumeral N3 instability) or (glenohumeral N3 unstable) ) OR AB ( (glenohumeral N3 joint) or
(glenohumeral N3 instability) or (glenohumeral N3 unstable) )
S4 TI ( (lesion* N3 Hill Sachs) or (lesion* N3 Bankart) ) OR AB ( (lesion* N3 Hill Sachs) or (lesion* N3 Bankart) )
S5 S1 or S2 or S3 or S4
S6 TI ( (immobilis* or immobiliz* or sling* or conservativ* or therap* or physiother* or rehabilitat* or mobilis* or mobiliz* or train* or exercis*
or physical therap*) ) OR AB ( (immobilis* or immobiliz* or sling* or conservativ* or therap* or physiother* or rehabilitat* or mobilis* or
mobiliz* or train* or exercis* or physical therap*) )
S7 (MH "Rehabilitation+") or (MH immobilization or immobilisation) or (MH “physical therapy”)
S8 MW rh OR MW th
S9 S6 or S7 or S8
S10 S5 and S9
S11 (MH "Clinical Trials+")
S12 (MH "Evaluation Research+")
S13 (MH "Comparative Studies")
S14 (MH "Crossover Design")
S15 PT Clinical Trial
S16 (MH "Random Assignment")
S17 S11 or S12 or S13 or S14 or S15 or S16
S18 TX ((clinical or controlled or comparative or placebo or prospective or randomi?ed) and (trial or study))
S19 TX (random* and (allocat* or allot* or assign* or basis* or divid* or order*))
S20 TX ((singl* or doubl* or trebl* or tripl*) and (blind* or mask*))
S21 TX ( crossover* or 'cross over' ) or TX cross n1 over
S22 TX ((allocat* or allot* or assign* or divid*) and (condition* or experiment* or intervention* or treatment* or therap* or control* or
group*))
S23 S18 or S19 or S20 or S21 or S22
S24 S17 or S23
Informed decisions.

S25 S10 and S24

S26 EM 2013 OR EM 2014 OR EM 2015 OR EM 2016 OR EM 2017 OR EM 2018
S27S25 and S26
PEDro
1. Abstract & Title: dislocate*
Body Part: upper arm, shoulder or shoulder girdle
Method: clinical trial
New records added since 01/09/2013
Match all search terms (AND)
2. Abstract & Title: sublux*

3. Abstract & Title: instability

WHO ICTRP
1. shoulder dislocation AND Immobiliz* OR shoulder dislocation AND immobilis* OR shoulder dislocation AND sling* OR shoulder
dislocation AND conservativ* OR shoulder dislocation AND therap* OR shoulder dislocation AND exercis* OR shoulder dislocation AND
rehabilitat* OR shoulder dislocation AND physiother* OR shoulder dislocation AND train* OR shoulder dislocation AND mobiliz* OR
shoulder dislocation AND mobilis* OR shoulder dislocation AND external rotation OR shoulder dislocation AND brace*
2. shoulder instability AND Immobiliz* OR shoulder instability AND immobilis* OR shoulder instability AND sling* OR shoulder instability
AND conservativ* OR shoulder instability AND therap* OR shoulder instability AND exercis* OR shoulder instability AND rehabilitat* OR
shoulder instability AND physiother* OR shoulder instability AND train* OR shoulder instability AND mobiliz* OR shoulder instability AND
mobilis* OR shoulder instability AND external rotation OR shoulder instability AND brace*
3. glenohumeral AND Immobiliz* OR glenohumeral AND immobilis* OR glenohumeral AND sling* OR glenohumeral AND conservativ*
OR glenohumeral AND therap* OR glenohumeral AND exercis* OR glenohumeral AND rehabilitat* OR glenohumeral AND physiother* OR
glenohumeral AND train* OR glenohumeral AND mobiliz* OR glenohumeral AND mobilis* OR glenohumeral AND external rotation OR
glenohumeral AND brace*
4. bankart lesion AND Immobiliz* OR bankart lesion AND immobilis* OR bankart lesion AND sling* OR bankart lesion AND conservativ* OR
bankart lesion AND therap* OR bankart lesion AND exercis* bankart lesion AND rehabilitat* OR bankart lesion AND physiother* OR bankart
lesion AND train* OR bankart lesion AND mobiliz* OR bankart lesion AND external rotation OR bankart lesion AND brace*
5. Hill Sachs AND Immobiliz* OR Hill Sachs AND immobilis* OR Hill Sachs AND sling* OR Hill Sachs AND conservativ* OR Hill Sachs AND
therap* OR Hill Sachs AND exercis* Hill Sachs AND rehabilitat* OR Hill Sachs AND physiother* OR Hill Sachs AND train* OR Hill Sachs AND
mobiliz* OR Hill Sachs AND mobilis* OR Hill Sachs AND external rotation OR Hill Sachs AND brace*
ClinicalTrials.gov
1. shoulder dislocation AND (Immobilization OR immobilisation OR sling OR conservative OR therapy OR exercise OR rehabilitation OR
physiotherapy OR training OR mobilization OR mobilisation) | First posted from 09/01/2013 to 05/22/2018
2. bankart lesion AND (Immobilization OR immobilisation OR sling OR conservative OR therapy OR exercise OR rehabilitation OR
physiotherapy OR training OR mobilization OR mobilisation) | First posted from 09/01/2013 to 05/22/2018
3. glenohumeral subluxation AND (Immobilization OR immobilisation OR sling OR conservative OR therapy OR exercise OR rehabilitation
OR physiotherapy OR training OR mobilization OR mobilisation) First posted from 09/01/2013 to 05/22/2018
WHAT'S NEW

Informed decisions.

Date Event Description
26 April 2018 New search has been performed For this version of the review, published in 2019, the following
changes were made.
1. The search was updated to May 2018.

2. Some additional subject headings were added to the database
search strategy.
3. Four main comparisons covering priority questions were listed
prospectively.
4. The risk of bias assessment was expanded to include separate
consideration of single or categories of outcomes in relation to
blinding of outcome assessment and completeness of outcome
data.
5. One adjusted and one new subgroup analysis was added prior
to the search update.
26 April 2018 New citation required and conclusions New authorship. Although the implications for practice are es-
have changed sentially unchanged, those for research have been expanded,
particularly in relation to patient subgroups and risk factors for
re-dislocation, and timing of follow-up.

HISTORY
Protocol first published: Issue 4, 2004
Review first published: Issue 1, 2006

Date Event Description
1 March 2014 New search has been performed For this version of the review, published in 2014, Issue 4, the fol-
lowing changes were made.
1. The search was updated to September 2013.

2. Four new trials (Finestone 2009; Itoi 2007; Liavaag 2011;
Taskoparan 2010) were included, and one previously included tri-
al (Itoi 2003) was excluded.
3. In accordance with the policy of The Cochrane Collaboration,
the review was updated to include new methodology, including
assessment of risk of bias.
4. A 'Summary of findings' table was added.
1 March 2014 New citation required and conclusions Although the review conclusions still point to an overall lack of
have changed evidence to inform practice, the inclusion of four new trials, all
of which compared immobilisation in external rotation versus
immobilisation in the traditional position of internal rotation,
brought a specific focus to the conclusions.
Changes were made to the byline, with one new review author
and removal of two previous review authors.
5 September 2008 Amended Converted to new review format.
Informed decisions.

CONTRIBUTIONS OF AUTHORS
The review update was developed by Cordula Braun (CB) and Cliona McRobert (CMR). CB contacted authors of eligible trials to inform
choices for study inclusion and to ask for extra information. Both review authors performed trial selection, quality assessment and data
extraction. CB compiled the first draft of the review and received critical feedback from CMR. Cordula Braun is the guarantor of the review.
Contributions of the editorial base

Helen Handoll (Co-ordinating Editor): edited the review; advised on methodology and review content; and approved the final version for
publication.
Joanne Elliott (Managing Editor): coordinated the editorial process; advised on content; and edited the review.
Maria Clarke (Information Specialist): updated the search and edited the search methods section.
DECLARATIONS OF INTEREST
Cordula Braun: none known
Cliona McRobert: none known
SOURCES OF SUPPORT
Internal sources
• Cochrane Germany, Germany.
External sources
• National Institute for Health Research (NIHR) via Cochrane Infrastructure funding to the Cochrane Bone, Joint and Muscle Trauma
Group, UK.
DIFFERENCES BETWEEN PROTOCOL AND REVIEW
Differences in the review update published in 2019

Prior to updating the search, the authors submitted a revised protocol section for the review that detailed the following.
• Clarification in Types of participants of acceptable concomitant injuries that are often associated with anterior shoulder dislocation.
• Listing of four main comparisons covering priority questions in Types of interventions.
• As planned in Hanchard 2014, the risk of bias assessment was expanded to include separate consideration of subjective and objective
outcomes in relation to blinding of outcome assessment and completeness of outcome data (Assessment of risk of bias in included
studies). However, grouping of outcomes in this way proved unsatisfactory and we thus assessed these domains separately for each
reported outcome.
• We changed the lower of two age thresholds for subgroup analysis from 25 to 20 based on recent evidence (Wasserstein 2016), and
added an additional subgroup analysis based on the presence or not of a greater tuberosity fracture (Olds 2015; Wasserstein 2016).
During the conduct of the review update, we made the following additional changes.
• We added a post hoc explanatory statement in Types of outcome measures on the exclusion of studies that solely addressed non-clinical
outcomes.
• We conducted an exploratory post hoc subgroup analysis of trials in which immobilisation in external rotation had an additional
abduction component versus those without (external rotation only).
• We made the post hoc decision to stratify 'adverse events' into 'transient and resolved' and 'important' as we considered this to more
appropriately reflect the available data.
Differences in the review update published in 2014

In line with Cochrane recommendations, the review now assesses risk of bias.
For this version of the review, outcomes were revised and, to comply with current Cochrane guidance, the number of primary outcomes was
reduced. We used GRADE to judge the quality of the evidence and have incorporated a 'Summary of findings' table: Summary of findings
for the main comparison.
As indicated in the Results, we anticipated organising outcomes within a framework of short term (up to and including three months
following dislocation), medium term (greater than three months and up to and including 12 months) and long term (longer than 12
months). Imposition of this framework was not necessary because all included studies reported outcomes in a mutually compatible
framework: during or shortly after immobilisation (some adverse events) or up to or beyond two years post dislocation.
Informed decisions.

INDEX TERMS
Medical Subject Headings (MeSH)

*Conservative Treatment; Immobilization [adverse effects] [*methods]; Joint Instability [etiology]; Randomized Controlled Trials as
Topic; Shoulder Dislocation [complications] [*therapy]
MeSH check words

Adult; Female; Humans; Male

Conservative Management Following Closed Reduction of Traumatic Anterior Dislocation of The Shoulder (Review)

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Conservative Management Following Closed Reduction of Traumatic Anterior Dislocation of The Shoulder (Review)

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Conservative management following closed reduction of traumatic

Cordula Braun1, Cliona J McRobert2

Editorial group: Cochrane Bone, Joint and Muscle Trauma Group

Data collection and analysis

None of the trials reported on participant satisfaction or health-related quality of life.

Certainty of the evidence

Re-dislocation Low riska RR 0.67 488 ⊕⊝⊝⊝

312 per 1000 209 per 1000

Cochrane Database of Systematic Reviews

417 per 1000 280 per 1000

Participant satis- See com- See com- - - - Outcome not reported

Quality of life See com- See com- - - - Outcome not reported

There were 3 'important' adverse events: hyperaesthesia

Cochrane Database of Systematic Reviews

GRADE Working Group grades of evidence

Cochrane Database of Systematic Reviews

BACKGROUND factors for recurrent instability after a primary traumatic anterior

* Wakefield A. The role of physiotherapy in the prevention randomized study. apps.who.int/trialsearch/Trial.aspx?

Additional references Handoll 2004

Kitamura 2005 O'Brien 1987

Lefebvre 2011 Olds 2015

Liavaag 2009 Paterson 2010

Liu 2014 Pennekamp 2006

Siegler 2010 predicting recurrent instability after nonsurgical management

van der Linde 2015 Zacchilli 2010

Characteristics of included studies [ordered by study ID]

Method of randomisation: independently by telephone

Assessor blinding: unclear

Intention-to-treat analysis: yes

Participants Setting: 6 (NHS) hospitals in England, UK

Period of data collection: September 2006 to February 2011

Group B: immobilisation in internal rotation in a conventional sling (Polysling, Mölnlnlycke Health

Outcomes Clinical reviews were conducted at 3, 12 and 24 months post dislocation

Prespecified as primary outcome

Re-dislocation (within 24 months): no information is provided on how re-dislocation was as-

Prespecified as secondary outcomes

Funding sources and declarations of interest:

Bias Authors' judgement Support for judgement

Comment: it is not clear whether these coordinators were blinded. It is unclear

Other bias Low risk Comment: none identified.

Method of randomisation: computer-generated randomised list

Intention-to-treat analysis: no information

Loss to follow-up: none

Participants Setting: Accident and Emergency Department of a University hospital, Israel

Age: mean 20 years, range 17 to 27 years

Assigned: 27/24 (Group A/B)

None of the outcomes was prespecified with the methods

Adverse events: undefined

Funding sources and declarations of interest:

Bias Authors' judgement Support for judgement

Allocation concealment Low risk Comment: see above

Other bias Low risk Comment: none identified.

Method of randomisation: computer-generated randomisation scheme

Assessor blinding: unclear

Participants Setting: emergency department of a university-affiliated hospital, Iran

Period of data collection: October 2011 to March 2013

Outcomes Follow-up assessments were conducted at 3 weeks post-intervention, at 24 months post-dislocation

Prepecified as primary outcome

Prespecified as secondary outcomes

Return to pre-injury sports: not further specified

Western Ontario Shoulder Instability Index (WOSI)

Adverse events: not prespecified as an outcome, undefined

Funding and declarations of interest: