Accepted Manuscript

Title: Comparison of three types of exercise in the treatment of

rotator cuff tendinopathy/shoulder impingement syndrome:a
randomised control trial assessing

Author: Stuart R. Heron Steve R. Woby Dave P. Thompson

PII: S0031-9406(16)30059-1
DOI: http://dx.doi.org/doi:10.1016/j.physio.2016.09.001
Reference: PHYST 930

To appear in: Physiotherapy

Please cite this article as: Heron Stuart R, Woby Steve R, Thompson
Dave P.Comparison of three types of exercise in the treatment of rotator
cuff tendinopathy/shoulder impingement syndrome:a randomised control trial
assessing.Physiotherapy http://dx.doi.org/10.1016/j.physio.2016.09.001

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Title: Comparison of three types of exercise in the treatment of rotator cuff

tendinopathy/shoulder impingement syndrome:a randomised control trial assessing

(ISRCTN76701121)

Author names and affiliations:

Stuart R Herona, Steve R Wobyb and Dave P Thompsonc

a
Department of Physiotherapy, The Pennine Acute Hospitals NHS Trust, North
Manchester General Hospital, Delaunays Road, Crumpsall, Manchester, United
Kingdom, M8 5RB
email: stuart.heron@pat.nhs.uk
b
Department of Research and Development, The Pennine Acute Hospitals NHS
Trust, North Manchester General Hospital, Delaunays Road, Crumpsall, Manchester,
United Kingdom, M8 5RB
email: steve.woby@pat.nhs.uk
c
Department of Physiotherapy, The Pennine Acute Hospitals NHS Trust, North
Manchester General Hospital, Delaunays Road, Crumpsall, Manchester, United
Kingdom, M8 5RB
email:david.thompson@pat.nhs.uk

Corresponding author:

Stuart R Heron
Address: Department of Physiotherapy, North Manchester General Hospital,
Delaunays Road, Crumpsall, Manchester, United Kingdom, M8 5RB
Telephone: +44 161 720 2423

Fax: +44 161 720 2490

Email: stuart.heron@pat.nhs.uk

1
Abstract

Objectives

To assess the efficacy of three different exercise programmes in treating rotator cuff

tendinopathy/shoulder impingement syndrome.

Design

Parallel group randomised clinical trial.

Setting

Two out-patient NHS physiotherapy departments in Manchester, United Kingdom

Participants

120 patients with shoulder pain of at least three months duration. Pain was

reproduced on stressing the rotator cuff and participants had full passive range of

movement at the shoulder.

Interventions

Three dynamic rotator cuff loading programmes; Open chain resisted band exercises

(OC) closed chain exercises (CC) and minimally loaded range of movement

exercises (ROM).

Main outcomes

Change in Shoulder Pain and Disability Index (SPADI) score and the proportion of

patients making a Minimally Clinically Important Change (MCIC) in symptoms six

weeks after commencing treatment.

2
Results

All three programmes resulted in significant decreases in SPADI score, however

there were no significant differences between the groups. Participants making a

MCIC in symptoms were similar across all groups, however more participants

deteriorated in the ROM group. Dropout rate was higher in the CC group, but when

only patients completing treatment were considered more patients in the CC group

made a meaningful reduction in pain and disability.

Conclusions

Open chain, closed chain and range of movement exercises all seem to be effective

in bringing about short term changes in pain and disability in patients with rotator cuff

tendinopathy.

Keywords: Shoulder pain; Rotator cuff tendinopathy; Shoulder impingement

syndrome; Exercise; Physiotherapy

Introduction

Shoulder pain is a common causes of primary care consultation,1 affecting 16-21%

of the general population2 and frequently persisting for many years,4. One of the

most common causes of shoulder pain is rotator cuff (RC) tendinopathy /shoulder

impingement syndrome (SIS)5 The pathoaetiology is not fully understood, but

thought to arise from acute and chronic changes in tendon structure and surrounding

bursa5. Pain caused by RC tendinopathy/SIS can cause functional impairment and

incur significant societal costs, estimated to be £310m per annum in the United

Kingdom6. Consequently, patients are frequently referred to physiotherapy to

improve their symptoms. Previous studies have demonstrated that exercise shows

3
promising results in treating RC tendinopathy/SIS6, with progressive loading

programmes of the RC suggested to be a key component of treatment6. However

different authors have advocated different loading strategies7,8 and it is unclear

which approach is superior. Therefore, the aim of this study was to compare the

efficacy of three different progressive loading programmes in treating patients with

RC tendinopathy/SIS. We hypothesised that all loading strategies would result in

improvements in symptoms.

Methods

Trial design

A parallel group randomised comparison trial comparing three exercise interventions

with a 1:1:1 ratio.

Participants

Participants were eligible for inclusion if they met the following criteria i) shoulder

pain for at least three months; ii) No passive limitation of range of movement

suggestive of adhesive capsulitis; iii) pain on isometric rotator cuff testing; iv) pain on

Hawkins-Kennedy or empty can tests; v) able to read and write English.

Participants were excluded according to the following criteria; i) symptoms of cervical

radiculopathy; ii) diagnosed inflammatory disorder; iii) neurological disorder; iv)

widespread pain condition; v) evidence of complete rotator cuff tear (positive drop

arm test or Oxford scale grade II or less strength of the rotator cuff); vi) previous

4
surgery to the affected shoulder. As part of ethical approval, participants were free

to drop out of the study at any point without providing a reason.

Study settings

Patients were recruited from two out-patient physiotherapy departments in

Manchester, UK between November 2005 and November 2009. Patients were

referred from both primary care and secondary care. All patients with shoulder pain

were sent an invitation letter and those providing written informed consent completed

a pre-treatment questionnaire. Participants underwent a standardised assessment

and those meeting the inclusion criteria were randomised via computer-generated

random number tables. Randomisation details were transposed to cards, which

were sealed in opaque envelopes and opened at the time of randomisation. The

interventions were delivered by eight physiotherapists, who were qualified for

between 5 and 16 years. The therapists each delivered all three interventions.

Patients not wishing to participate received physiotherapy as usual.

Blinding

It was not possible to blind participants and physiotherapists, due to the nature of the

interventions. However, it was made clear in the patient information sheet that exercise had

been shown to be effective for treating this condition, however it was unknown whether one

type of exercise was better than another. No indication was given which suggested that any

of the interventions was potentially superior and it was made clear that all three loading

strategies were used for treating this condition. The authors were blinded to treatment

allocation when data were analysed.

5
Study interventions

A literature search was performed to identify studies utilising different exercise

modalities in the treatment of RC tendinopathy/ SIS. All relevant articles were

identified and reviewed by a panel of five experienced physiotherapists. The panel

met to discuss these studies and develop the interventions based around best

evidence. Generally, previous studies employed dynamic loading strategies for the

RC. However, there was no clear consensus as to the optimal method of loading.

Therefore three groups were decided upon; minimally-loaded range of movement

exercises, open chain loading and closed chain loading exercises (see below).

Participants completed three sets of 10 repetitions, twice per day. Participants were

advised that they could exercise into pain, but not to the extent where increased pain

resulted in a significant reduction in function or to the extent that pain was

significantly worse for more than one hour afterwards.

In addition, all participants were taught stretching exercises for the anterior and

posterior shoulder capsule8. These exercises were included as they were part of the

protocol previously shown to be efficacious in treating shoulder pain. However, as

all participants completed these exercises, the unique treatment in each group was

the different loading strategy. Participants were instructed to hold each stretch for 5

seconds and perform five repetitions, twice per day. Participants attended three

appointments over six weeks, with the exercises progressed in difficulty at each

appointment. This treatment schedule was selected as it reflected usual practice in

6
the treating departments at the time of the study. Diagrams were provided to all

patients demonstrating the exercise techniques (web appendix 1).

Open chain resisted exercises (OC)

Participants performed lateral rotation, medial rotation and abduction to

approximately 30o using rubber resistance bands. The length of each band was

adjusted for each patient so that the band was taught, but not stretched at the

starting point of each exercise. The resistance of the band was set by the treating

physiotherapist so that the participant reported that the exercise was challenging

without being excessively painful and they were able to complete 10 repetitions

before needing to rest. Most participants initially started using red band and were

progressed to green or black as soon as they were able to complete three sets of 10

with this band. Exercises were also progressed by increasing the magnitude of

abduction to 90o7-10.

Closed chain exercises (CC)

Participants performed exercises to activate the rotator cuff as a group7,9, namely a

double-arm wall press up, a press up in four point kneeling and an exercise whereby

the participant adopted a seated position and pressed their hands into the chair, as if

trying to lift their body. The exercises were progressed so that the first two

exercises were performed using only the symptomatic arm and participants aimed to

lift their body clear of the chair with the third exercise.

7
Range of movement exercises (ROM)

Participants performed range of movement exercises, initially with no resistance and

then using only gravity to provide resistance. They were initially taught passive

shoulder abduction using a stick, lateral rotation with the arm by the side and medial

rotation using the other arm to assist in sliding their arm up their back. Exercises

were progressed so participants performed active abduction to 90o and performed

lateral and medial rotation exercises in 90o of abduction.

Measures

The primary outcome was change in Shoulder Pain and Disability Index (SPADI)

score. The SPADI is a 13 item self-reported questionnaire assessing pain and

functional status. Each item is measured on a 0-10 scale and a 0-100 score

calculated. Higher scores represent greater levels of pain and disability. The SPADI

has been shown to have good test-re-test reliability11,12 and be sensitive to change13.

The minimal clinically important change in SPADI is considered to be a 10 point

reduction12,14. Participants also completed an exercise diary reporting how

frequently they performed the exercises.

Sample size calculation

For one regime to be considered superior, it would be necessary to demonstrate a

clinically meaningfully larger (i.e. 10 points) decreases in SPADI score. Previous

physiotherapy-based studies have reported standard deviations in SPADI score of

between 9.6515 and 20.916, therefore a conservative figure of 15 was used.

8
Therefore, to provide a power level of 80% and statistical significance of 0.05, 36

participants per group were required.

Follow up

Participants completed a questionnaire six weeks after commencing treatment re-

assessing SPADI score. If participants did not return the questionnaire further

questionnaires were posted out. If participants still did not return the questionnaire

they were contacted by telephone.

Statistical analyses

Preliminary examination of the data

Levene and Shapiro-Wilk tests were performed to assess whether SPADI change

scores met assumptions of parametric data. Intention-to-treat principles were

employed and where data were missing baseline values were carried forward.

Within group pre-to-post treatment mean total SPADI change scores were calculated

using Wilcoxon Signed-rank tests and effect sizes were calculated for each group.

Primary analysis

SPADI change scores did not meet the assumptions of parametric data, therefore

non-parametric analyses were performed. Between group mean total SPADI change

scores were analysed using the Kruskal-Wallis test.

9
Secondary analyses

Minimal clinically important change (MCIC) analyses

In addition to group level analysis, data were analysed for individual patients to

assess whether they had made a MCIC in SPADI score. Participants whose SPADI

score decreased by 10 points or more were classified as clinically significantly

improved, whereas those whose SPADI score increased by 10 points or more were

classified as clinically deteriorated. In addition, Drop-out rates (i.e. participants who

did not provide follow up data) were compared between groups and MCICs were re-

analysed including only participants providing follow up data.

Results

120 participants were recruited to the study (see figure 1. for Consort diagram).

There were no significant differences in baseline demographic factors (Table. 1.).

Preliminary analysis of the data

All three groups showed statistical significant reductions in SPADI score at six week

follow up (Table 2.).

10
Primary analysis

There were no statistically significant differences between the groups on the Kruskal-

Wallis test (Table. 3.).

Drop outs

Significantly more participants failed to complete the intervention and did not provide

follow up data in CC group (n=19; 48%) than the OC (n=10, 25%) or ROM (n=9;

23%) groups.

MCIC analysis

There were no differences in the proportion of patients making a clinically important

improvement in SPADI score at follow up. However, 10% of patients in the ROM

group reported a clinically meaningful deterioration in symptoms, compared to zero

in the OC and CC groups. When only participants who provided follow up data were

considered, the proportion making a clinically meaningful improvement rose to 76%

for the CC group, 57% for OC and 52% for ROM (Table 4.).

Exercise compliance

Exercise diaries were completed by 14 participants in the ROM group, 12 in the OC

and 13 in the CC. Table 5. shows frequency of exercise completion amongst

participants. Although participant reported compliance with the exercise programme

was generally good, qualitative feedback from clinicians was that some patients were

11
unable to reproduce their exercises independently, despite reporting compliance

upwards of 75%.

Discussion

The aim of this study was to establish which type of RC loading programme was

most effective in patients with RC tendinopathy/SIS. The primary analysis

demonstrated that all three groups showed improvement in shoulder pain and

disability but no approach resulted in superior outcomes. This may suggest that the

specific exercise is not important, so long as the RC is dynamically loaded.

It should be noted however that the drop-out rate was higher than anticipated,

meaning that the analyses lacked power to make definitive conclusions. That said,

examination of the SPADI change scores revealed that none of the programmes

came close to approaching an improvement of 10 points more than the other groups.

Moreover, participants who did not provide follow up data were still included in the

analyses, albeit assuming no changes had occurred in their symptoms. Although

further research is required to conclusively confirm these findings, the current results

do not provide any suggestion that one exercise approach may be superior to

another in treating RC tendinopathy.

It has previously been suggested that the improvements in tendinopathy symptoms

following exercise could be attributed to structural changes within the tendon17.

However, a recent review suggested that only heavy slow resistance training

12
demonstrated a clear relationship between changes in tendon structure and

improvement in symptoms18. For other types of exercise, either inconsistent or

negative findings were observed. Given that slow heavy resistance training was not

utilised in this study, it is unclear whether improvements can be attributed to tendon

restructuring. Other mechanisms have been suggested to account for improvements

in tendinopathy, such as biochemical changes, or reductions in sensitivity of the

central and peripheral nervous system18.

That symptoms can improve without tendon structure changes may account for why

all three programmes used in this study proved to be beneficial. Feasibly, repeated

activation of the RC may have reduced peripheral and/or central neurological

sensitivity, or resulted in reductions in biochemical driven nociception. It is also

possible that changes in psychosocial factors may have contributed to the

improvements observed. Re-assurance from the treating clinician and gradual

exposure to increasing use of the shoulder may have reduced psychological risk

factors, which have been shown to be related to pain and disability in other musculo-

skeletal conditions19. However, the mechanisms underpinning the beneficial effects

of exercise in tendinopathy are currently poorly understood and further research is

warranted.

Given the lack of group-level differences in the primary analysis, it is worth noting

that some interesting differences emerged in the secondary analyses. Firstly,

significantly more participants dropped out from the CC intervention. This may

suggest that some exercise regimes are less acceptable to patients than others.

13
Interestingly, although dropout rate was higher in the CC group, participants who

continued with the programme were more likely to make a MCIC in pain and

disability (76% versus 52% and 57%). This may merely be reflective of the greater

dropout rate in the CC group meaning fewer participants provided data showing a

lack of clinical improvement. However, it is also possible that CC exercises do

confer some additional benefit if participants are able to persist with them, but

patients are also more likely to dis-engage from treatment.

A possible explanation for the greater drop-out rate in the CC group may be the

influence of patients’ expectations and exercise preferences. Several of the

clinicians involved in the study reported that participants felt that the CC exercises

were not “specific” enough for their problem. It is feasible that this led to some

patients dis-engaging from treatment, whereas those who persisted obtained further

benefit. It should also be noted that in the participating departments, usual practice

prior to the study was to treat RC tendinopathy predominantly with OC exercises and

it is possible that therapists’ preferences may have influenced outcome. If the

clinicians held a strong preference for one type of exercise, they may have been less

enthusiastic or confident in their explanations as to why other exercises would be

beneficial. This may have affected patients’ adherence to the exercises.

Although data were collected regarding exercise compliance, insufficient participants

completed the diaries to enable meaningful analysis. Moreover, most participants

reported excellent compliance with the exercises, however anecdotal reports from

clinicians suggested that this was not always an accurate reflection of a participant’s

14
compliance. It is possible that patients reported excellent compliance in an effort to

please their clinician whilst in reality performing the exercises less often. It is

therefore difficult to analyse the role that exercise compliance played in this study.

An interesting area for future study would be to employ qualitative methods to

assess patients’ opinions as to why they persisted or discontinued certain exercise

programmes. This will help to clarify which factors maximise patients’ compliance

with exercise and may therefore aid clinicians in prescribing exercise programmes

that are most acceptable to patients and therefore most efficacious.

A second interesting finding to emerge from the secondary analyses was that all

participants who deteriorated by a clinically meaningful amount were in the ROM

group. It is unlikely that this is due to excessive loading of the RC, as the ROM

group was likely to have placed the least demand on the shoulder, as no external

resistance was added. Conversely, it is possible that greater loading intensities may

be more effective in increasing the likelihood of a positive response to exercise, as

shown in other musculoskeletal conditions20.

It should be noted that only four participants reported a clinical deterioration and

therefore strong conclusions cannot be drawn based on such low numbers.

Nevertheless, given that ROM exercises were no better at reducing pain and

disability, but were more likely to result in clinical deterioration, it would seem

prudent to prescribe either OC or CC exercises in preference to ROM exercises.

15
Furthermore, a combination of both types of exercises may be most effective, as it

may draw on the positive aspects of both forms of exercise. Alternatively, it is

plausible that a key component in successful rehabilitation of RC tendinopathy is

patient compliance. Given that the current study did not conclusively demonstrate

superiority of one type of exercise, patient’s exercise preference should be sought

when prescribing exercises. Moreover, if one exercise modality is excessively

exacerbating symptoms, a useful strategy may be to switch to an alternative loading

programme.

Comparison to previous studies

The current study supports previous work demonstrating that loading exercises can

bring about positive short and longer term changes in patients with RC

tendinopathy/SIS8-10,21. Unfortunately, these studies have employed different

outcome measures, precluding direct comparison of the efficacy of the interventions

employed in these studies.

Limitations

The current study has some limitations which are worthy of note. Firstly, there was a

high dropout rate amongst participants, particularly in the CC group. It is possible

that participants who discontinued treatment did so because of worsening

symptoms, which may mean that the current study over-estimated the efficacy of the

studied interventions. Conversely, given that missing data were entered assuming

no change, it is possible that the current study under-estimated the true effect of

16
each exercise programme. When the analyses were performed utilising only

participants providing data, there were still no significant differences between the

groups, but the changes in SPADI score were much higher (OC=15, CC=16,

ROM=12; data not presented). That said, future studies should employ alternative

methods of post-treatment data collection, such as online questionnaires or

telephone follow up to maximise data collection.

Secondly, data were only collected for six weeks after commencing treatment. It is

possible that some participants continued to exercise and improve beyond this

timeframe, which may have led to greater improvements if longer follow-up was

performed. Furthermore, the short follow up period means that the long term

efficacy of the exercise regimes is unclear from this study.

Thirdly, all groups performed stretching exercises and the study did not include a no-

treatment or stretching only group. As no significant differences emerged between

groups, it is possible that the effective component of treatment was the stretching

exercises. Whilst some studies of other tendinopathies report stretching exercises

are as effective as loading exercises22,23, others have reported inferior outcomes

when stretching alone has been utilised20. However, given that at the time of the

initiation of the study there were few studies exploring the role of exercise in RC

tendinopathy/SIS and that studies which had demonstrated the efficacy of exercise

had included these stretches in their programmes, the authors felt it important to

offer treatment based around best available evidence.

17
Conclusions

Monitored home exercise programmes appear to be an effective short-term

treatment for RC tendinopathy/SIS, however the content of the exercise programme

does not appear to affect group-level outcome. That said, participants treated with

CC exercises were more likely to obtain a MCIC if they persisted with the exercises,

however were also more likely to dis-engage from treatment. It is plausible that a

mixture of open and closed chain exercises, taking into account participants’

preferences and response to exercise may be the most effective treatment regime.

Conflict of interest

The authors declare no conflict of interest.

Ethical approval

Ethical approval was provided by the North Manchester Local Research Ethics
Committee, REC Reference Number: 05/Q1406/90.

Funding

Funding for this study was provided by the Pennine Acute Hospitals NHS Trust
Research and Development Department.

18
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22
 Table 1. Table showing demographic information for each treatment group

ROM group OC group CC group

Age 49.5 50.4 49.8
Sex (%)male 25 (62.5%) 24 (60%) 22 (55%)
female 15 (37.5%) 16 (40%) 18 (45%)
Not working due to shoulder pain 0 0 1
Completed treatment (%) 31(77%) 30(75%) 21 (52%)
Pain duration:
3 months-1 year 23 (57.5%) 29 (72.5%) 26 (65%)
Longer than one year 17 (42.5%) 11 (27.5%) 14 (35%)
Baseline SPADI score 51 49 53

Table 2. Mean pre-post treatment changes and effect sizes for each treatment group

Treatment group Pre-treatment Post-treatment Mean change Wilcoxon Effect size

SPADI score SPADI score in SPADI score signed rank
test
significance
Range of 51 42 9 0.0002 0.49
Movement (n=40)
Open Chain (n=40) 49 37 12 0.0001 0.56
Closed Chain (n=40) 53 44 9 0.0002 0.63

Group Median pre-treatment Median post treatment Median change SPADI

SPADI (IQR) SPADI (IQR) (95% CI)
ROM (n=40) 54 (35-66) 39 (24-56) -4.0 (- 5.4 – -17)
Open Chain (n=40) 48 (30-70) 34 (19-53) -3.5 (-4.8 – 12)
Closed Chain (n=40) 54 (36-68) 49 (22.7-59) -0.5 (-3.3 – 15)
Table 3. Kruksal-Wallis Test assessing between group differences in change in SPADI score

* = Significant between-group difference in median change scores (p<0.05)

23
Table 4. The proportion of participants making a minimally clinically important change (MCIC) in
total SPADI score following treatment.

Group Open Closed Range of

Chain Chain Movement

Number of participants making a MCIC improvement 17/40 16/40

16/40 (40%)
(43%) (40%)

Number of participants making a MCIC deterioration 0/40 (0%) 0/40 (0%) 4/40 (10%)

Number of participants dropping out 10/40 19/40

9/40 (23%)
(25%) (48%)
Number of participants making a MCIC improvement
when only participants completing treatment are 17/30 16/21
16/31 (52%)
considered (57%) (76%)

Table 5. Participants’ self-reported frequency of completion of the exercise regime.

Range of Closed
Percentage of prescribed Open Chain
Movement Chain
exercises completed

76-100% 12 (86%) 10 (83%) 11 (85%)

51-75% 2 (14%) 2 (17%) 1 (7.5%)
26-50% 0 (0%) 0 (0%) 1 (7.5%)
≤ 25% 0 (0%) 0 (0%) 0 (0.0)

24
 Invited to participate (n = 473)

Excluded (n = 353)

Declined to participate (n = 141)

Not meeting inclusion criteria after assessment (n = 165)
Unable to read English (n=47)
ENROLLMENT

Randomized (n = 120)

Range of Movement Open Chain Closed Chain

Allocated for intervention (n = 40) Allocated for intervention (n = 40) Allocated for intervention (n = 40)
ALLOCATED

 Received allocated intervention (n  Received allocated intervention (n  Received allocated intervention (n

= 40) = 40) = 40)
 Did not receive allocated  Did not receive allocated  Did not receive allocated
intervention (n = 0) intervention (n = 0) intervention (n = 0)

Lost to follow up (n = 9) Lost to follow up (n = 10) Lost to follow up (n = 19)

Reason(s) : Reason(s) : Reason(s) :

Did not return follow up Did not return follow up Did not return follow up
FOLLOW UP

questionnaire (n = 9) questionnaire (n = 10) questionnaire (n = 19)

Discontinued intervention (n = 9) Discontinued intervention (n = 10) Discontinued intervention (n = 19)

Reason(s) : Reason(s) : Reason(s) :
Failed to attend follow up Failed to attend follow up Failed to attend follow up
appointment (n = 7) appointment (n = 7) appointment (n = 7)

Reported adverse events n=0 Reported adverse events n=0 Reported adverse events n=0
ANALYSIS

Analysed (n = 31) Analysed (n = 30) Analysed (n = 21)

Excluded from analysis (n = 0) Excluded from analysis (n = 0) Excluded from analysis (n = 0)

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