Exercise for treating patellofemoral pain syndrome (Protocol)

van der Heijden RA, Lankhorst NE, van Linschoten R, Bierma-Zeinstra SMA, van
Middelkoop M

This is a reprint of a Cochrane protocol, prepared and maintained by The Cochrane Collaboration and published in The Cochrane
Library 2013, Issue 2
http://www.thecochranelibrary.com

Exercise for treating patellofemoral pain syndrome (Protocol)

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
 TABLE OF CONTENTS
HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1
BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2
METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
CONTRIBUTIONS OF AUTHORS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
DECLARATIONS OF INTEREST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
SOURCES OF SUPPORT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Exercise for treating patellofemoral pain syndrome (Protocol) i

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
[Intervention Protocol]

Exercise for treating patellofemoral pain syndrome

Rianne A van der Heijden1 , Nienke E Lankhorst1 , Robbart van Linschoten1 , Sita MA Bierma-Zeinstra1 , Marienke van Middelkoop1
1 Department of General Practice, Erasmus Medical Center, Rotterdam, Netherlands

Contact address: Marienke van Middelkoop, Department of General Practice, Erasmus Medical Center, Burg Jacobplein 51, Rotterdam,
3015CA, Netherlands. m.vanmiddelkoop@erasmusmc.nl.

Editorial group: Cochrane Bone, Joint and Muscle Trauma Group.

Publication status and date: New, published in Issue 2, 2013.

Citation: van der Heijden RA, Lankhorst NE, van Linschoten R, Bierma-Zeinstra SMA, van Middelkoop M. Exercise for
treating patellofemoral pain syndrome. Cochrane Database of Systematic Reviews 2013, Issue 2. Art. No.: CD010387. DOI:
10.1002/14651858.CD010387.

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

ABSTRACT
This is the protocol for a review and there is no abstract. The objectives are as follows:
To assess the effects (benefits and harms) of exercise therapy aimed at reducing knee pain and improving knee function for people with
patellofemoral pain syndrome.

Exercise for treating patellofemoral pain syndrome (Protocol) 1

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
BACKGROUND
Description of the condition
Patellofemoral pain syndrome (PFPS) is a common problem
among adolescents and young adults. Its incidence varies from 22
new cases per 1000 persons/year in highly active populations to
five to six new cases per 1000 in general practice (Boling 2009;
van der Linden 2004). PFPS is characterised by retropatellar pain
(behind the kneecap) or peripatellar pain (around the kneecap),
mostly occurring when load is put on the knee extensor mecha-
nism such as when climbing stairs, squatting, running, cycling or
sitting with flexed knees.
Several factors have been implicated in the etiology of PFPS. These
include local factors (contribution of patellofemoral joint mechan-
ics and surrounding tissues to patellofemoral pain), distal factors
(contribution of foot and ankle mechanics) and proximal factors
(contribution of hip, pelvis and trunk mechanics) (Davis 2010).
However, the etiology of the condition is still unclear, as is the
origin of the pain.
Description of the intervention
The majority of people with PFPS are treated conservatively
(non-surgically). Physically-based conservative interventions in-
clude knee orthoses, foot orthoses (Hossain 2011), patellar taping
(Callaghan 2012) and exercise therapy.
Most exercise therapy programmes for PFPS have focused on
strengthening the quadriceps muscles, which was seen as the most
promising conservative treatment method for patellofemoral pain
syndrome (Heintjes 2003; Powers 1998; Thomee 1999). More
recently, studies have focused on the hip muscles as a possible ori-
gin of patellofemoral pain (Souza 2009a; Souza 2009b; Willson
2008).
Exercise therapy comprises a broad range of possible variations
and accompanying terms. Activity of the quadriceps muscles - and
other muscles involved in knee function - can either be concen-
tric, eccentric or isotonic. During concentric activities the muscles
shorten, whereas during eccentric activities muscles lengthen in
an actively controlled manner. During isotonic activity the muscle
tension remains the same. Exercises can either be static/isometric
or dynamic. Exercises are referred to as static/isometric if the posi-
tion of the knee does not change. If the position of the knee does
change, the exercise is called dynamic. In cases where the lower
leg moves at a predetermined, constant speed which requires an
isokinetic dynamometer to control the velocity, the dynamic exer-
cise is also called isokinetic. Exercises where the foot is in contact
with a fixed surface are referred to ’closed kinetic chain exercises’,
as opposed to ’open kinetic chain’ exercises where the surface is
not fixed.
Hence, exercises can be described in three dimensions: the type
of muscle activity (concentric, eccentric, isotonic), joint move-
Exercise for treating patellofemoral pain syndrome (Protocol)
Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
ment (dynamic versus no movement: isometric or static) and the
presence of reaction forces caused by contact of the foot with a
fixed surface (closed versus open kinetic chain) (Witvrouw 2000;
Witvrouw 2004). Combinations of the above denominations ap-
ply to every type of exercise, and the terminology used for exercise
programmes reflects the emphasis intended by the therapist or re-
searcher.
Besides strengthening of the quadriceps muscle, many exercises
will also result in the coordination of muscle contraction. Empha-
sis during exercise therapy may be put on the coordinated con-
traction of the medial and lateral parts of the quadriceps mus-
cle, and also on the coordinated contraction of hip adductor, hip
abductor and gluteal muscles (Mellor 2005). Electromyographic
biofeedback visualises specific muscle contractions and may help
the patient target the required muscle during exercise.
In addition, there are other differences such as in the delivery of
exercise, for example supervised exercise versus home exercise; or
in the duration or intensity of exercise.
How the intervention might work
A recent published review on factors associated with PFPS con-
cluded that patients with PFPS have lower knee extension strength,
lower hip extension strength and decreased flexibility of the
lower extremity muscles compared with people without PFPS
(Lankhorst 2012). Exercise programmes that comprise static and
dynamic muscular exercises for both quadriceps and hip muscles
are aimed to improve the strength of these muscles and conse-
quently reduce the pain. Furthermore, many exercise programmes
also focus on improving the flexibility of the lower extremity by
adding stretching exercises.
Why it is important to do this review
Patellofemoral pain syndrome (PFPS) is a common problem
among adolescents and young adults. Its etiology, including the
structures causing the pain, and treatment methods are all debated
in literature, but consensus has not been reached so far. Exercise
therapy to strengthen the quadriceps is often prescribed, though
its efficacy is still debated. This updates and supercedes a former
Cochrane review (Heintjes 2003).
OBJECTIVES
To assess the effects (benefits and harms) of exercise therapy aimed
at reducing knee pain and improving knee function for people
with patellofemoral pain syndrome.
2
METHODS
Criteria for considering studies for this review
Types of studies
Randomised and quasi-randomised (method of allocating partici-
pants to a treatment which is not strictly random: e.g. by hospital
number) controlled clinical trials which evaluate exercise therapy
for patellofemoral pain syndrome will be included.
Types of participants
Adolescents and adults with patellofemoral pain syndrome (des-
ignated by the trial author(s) as such or as ’anterior knee pain syn-
drome’, ’patellar dysfunction’, ’chondromalacia patellae’ or ’chon-
dropathy’).
Studies focusing on other named knee pathologies such as Hoffa’s
syndrome, Osgood Schlatter syndrome, Sinding-Larsen-Johans-
son syndrome, iliotibial band friction syndrome, tendinitis, neu-
romas, intra-articular pathology including osteoarthritis, rheuma-
toid arthritis, traumatic injuries (such as injured ligaments, menis-
cal tears, patellar fractures and patellar luxation), plica syndromes,
and more rarely occurring pathologies, will be excluded (Nissen
1998; Thomee 1999).
Types of interventions
We will include studies evaluating exercise therapy for
patellofemoral pain syndrome. Exercises can be applied on their
own or in combination with other non-surgical interventions, pro-
vided the same other intervention is applied to the whole popu-
lation in the comparison. Exercises can be performed at home or
under supervision of a therapist.
Comparisons:
1. Exercise therapy versus control (no treatment, placebo or
waiting list controls). This also includes ’exercise therapy +
another intervention (e.g. taping) versus the other intervention
alone (e.g. taping)’.
2. Exercise therapy versus different conservative interventions
(e.g. taping).
3. Comparisons of different exercises
1. i) Delivery of exercises or exercise programmes (e.g.
supervised versus home exercise; group versus individual
supervision).
ii) Medium of exercises or exercise programmes (water
versus land based exercise).
iii) Types of exercise (e.g. closed versus open kinetic chain
exercises; dynamic versus isometric).
Exercise for treating patellofemoral pain syndrome (Protocol)
Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
iv) Target of exercise (strengthening of hip or abdominal
muscles versus quadriceps muscles)
v) Duration of exercises or exercise programmes (e.g.
long duration (more than three months) versus shorter duration
(less than three months)).
vi) Intensity of exercises or exercise programmes (e.g. high
intensity (several times per week) versus low intensity (once
weekly)).
The intervention groups for comparisons of different exercises will
be defined as the most novel intervention (and first listed) of the
two exercises being compared. For instance, the intervention is
supervised exercise and the control is home exercise in the first
comparison of 3a. Consideration will also be given to consistency
in the choice of control groups.
Combined interventions or treatment packages including exercise
will not be tested in this review, with the exception of exercises
provided with instructions or advice, where exercise is the pre-
dominant intervention.
Types of outcome measures
Primary outcomes
1. Knee pain measured by validated self reporting methods
(Visual Analog Scale [VAS], numerical rating scale [NRS] of
McGill Pain questionnaire) (Melzack 1987). Pain scores are
reported for pain in daily life (usual pain), for worst pain and for
pain at activities (e.g. sports) if available (Crossley 2004).
Secondary outcomes
1. Functional ability (i.e. knee function in activities of daily
living). Questionnaires focusing on knee function (such as
Functional Index Questionnaire (Chesworth 1989), WOMAC
Osteoarthritis Index (McConnell 2001), Kujala Patellofemoral
Function Scale (Kujala 1993) and Lysholm scale (Lysholm
1982)).
2. Functional performance tests (squatting, hopping on one
leg, etc) (Loudon 2002).
3. Subjective perception of recovery. Recovery from
patellofemoral pain syndrome is a outcome measure
inconsistently reported in studies and different methods are used
to describe recovery. In this review, ’number of patients no
longer troubled by symptoms’ or ’perceived recovery’ measured
on a Likert scale will be included as a secondary outcome
measure (van Linschoten 2006).
4. Adverse events (e.g. knee swelling or substantially increasing
pain levels as a direct effect of treatment).
Changes in knee function measured on impairment level only
(e.g. range of motion, muscle strength) do not directly represent
changes in the symptoms of patellofemoral pain or the resulting
disability, and will therefore not be considered clinically relevant
outcome measures in this review (Dursun 2001; Gobelet 1992).
3
Timing of outcome measurement
Outcomes measured within three months after the baseline mea-
surement will be considered short term outcomes of exercise ther-
apy, and measurements from three months and longer will be con-
sidered long term outcomes.
Search methods for identification of studies
Electronic searches
We will search the Cochrane Bone, Joint and Muscle Trauma
Group Specialised Register, the Cochrane Central Register of
Controlled Trials (The Cochrane Library), MEDLINE (1946
to present), EMBASE (1980 to present), PEDro - The Phys-
iotherapy Evidence Database (to present), CINAHL (1982 to
present) and AMED (1985 to present). We will also search
the WHO International Clinical Trials Registry Platform and
Current Controlled Trials for ongoing and recently completed tri-
als.
In MEDLINE (Ovid Online), a subject-specific strategy will be
combined with the sensitivity-maximizing version of the Cochrane
Highly Sensitive Search Strategy for identifying randomised tri-
als (Lefebvre 2011). Search strategies for MEDLINE and the
Cochrane Central Register of Controlled Trials are shown in
Appendix 1.
No language restrictions will be applied.
Searching other resources
Reference lists of included studies and other relevant articles will
be checked for additional trials, and institutions and experts in
the field will be contacted in order to identify unpublished stud-
ies. Furthermore, conference abstracts will be searched from spe-
cific patellofemoral pain syndrome conferences such as the inter-
national patellofemoral research retreat (Davis 2010).
Data collection and analysis
Selection of studies
Two review authors (RAH and NEL) will select potentially eli-
gible articles by reviewing the title and abstract of each citation.
After obtaining full articles, both authors will independently per-
form study selection. In cases of disagreement, a consensus will be
reached through discussion.
Exercise for treating patellofemoral pain syndrome (Protocol)
Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Data extraction and management
Two review authors (RAH and NEL) will independently extract
the data within included trials using a piloted data collection form.
Any disagreements will be resolved by consensus. Where data are
missing or incompletely reported, authors of trials will be con-
tacted. Where pooling is possible and if necessary, pain scores
(VAS, NRS) will be converted to a 0 to 10 scale and function
scores to 0 to 100 scale.
Assessment of risk of bias in included studies
Two review authors (RAH and NEL) will independently assess
the risk of bias of the included studies using The Cochrane Col-
laboration’s ’Risk of bias’ tool (Higgins 2011). The following do-
mains will be assessed: random sequence generation; allocation
concealment; blinding of participants and personnel; blinding of
outcome assessment; incomplete outcome data; selective report-
ing; and other bias. Other sources of bias will include bias from
major imbalance in baseline characteristics and performance bias
such as from lack of comparability in clinician’s experience with
the interventions under test or differences in care other than the
interventions under test.
Each of these criteria will be explicitly judged using: low risk of
bias; high risk of bias; and unclear risk of bias (where ’unclear’
relates to a lack of information or uncertainty over the potential
for bias). Disagreements between review authors regarding the risk
of bias for domains will be resolved by consensus.
Measures of treatment effect
Risk ratios with 95% confidence intervals will be calculated for
dichotomous outcomes. Mean differences with 95% confidence
intervals will be calculated for continuous outcomes as appropri-
ate. When two or more studies present their data derived from the
same instrument of evaluation (with the same units of measure-
ment), data will be pooled as a mean difference (MD). Conversely,
we will use the standardised mean difference (SMD) when primary
studies express the same variables through different instruments
(and different units of measurement).
Unit of analysis issues
The unit of randomisation in the studies likely to be included in
this review is usually the individual participant. Exceptionally, as
in the case of trials including people with bilateral complaints,
data for trials may be evaluated for knees, instead of individual
patients. Where such unit of analysis issues arise and appropriate
corrections have not been made, we will consider presenting the
data for such trials only where the disparity between the units of
analysis and randomisation is small. Where data are pooled, we
will perform a sensitivity analysis to examine the effects of pooling
these incorrectly analysed trials with the other correctly analysed
trials.
4
For multi-comparison studies, we will attempt to combine data
where two or more of the groups test interventions in the same
category. Should combining not be appropriate but the data are
presented for the difference comparisons are presented in the same
analysis, the number of participants in the shared comparison will
be divided (e.g. halved where this intervention appears twice) in
order to avoid the ’double-counting’ of participants for the ’shared
comparison’ in the meta-analyses. For cross-over trials, we will
present data collected prior to the crossover of the intervention.
Dealing with missing data
We will contact trial authors where further details of methodology
or data are required for trial inclusion.
Where possible we will perform intention-to-treat analyses to in-
clude all people randomised. However, where drop-outs are iden-
tified, the actual numbers of participants contributing data at the
relevant outcome assessment will be used. We will be alert to the
potential mislabelling or non-identification of standard errors and
standard deviations (SDs). Unless missing standard deviations can
be derived from confidence intervals or standard errors, we will
consider whether it is appropriate to estimate values based on com-
parable data included in this review in order to present these in the
analyses. We will make clear for which trials imputed data have
been used (e.g. footnotes in the forest plots).
Where data are presented as the median (inter-quartile range),
we will not attempt to transform data to achieve normality or to
estimate the mean and SD.
Assessment of heterogeneity
Heterogeneity will be assessed by visual inspection of the forest
plot (analysis) along with consideration of the chi² test for hetero-
geneity and the I² statistic (Higgins 2011). Heterogeneity will be
considered statistically significant at P < 0.1. Studies will also be
examined for methodological and clinical heterogeneity, particu-
larly if significant statistical heterogeneity is identified.
Assessment of reporting biases
Where data for at least 10 studies are available for pooling, we will
assess for publication bias by using funnel plots (Higgins 2011).
Data synthesis
When considered appropriate, results of comparable groups of
trials will be pooled using both fixed-effect and random-effects
Exercise for treating patellofemoral pain syndrome (Protocol)
Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
models. The choice of the model to report will be guided by a
careful consideration of the extent of heterogeneity and whether it
can be explained, in addition to other factors such as the number
and size of studies that are included.
Subgroup analysis and investigation of heterogeneity
Where data permit, we will perform the following subgroup anal-
yses:
• Gender
• Duration of complaints (acute (less than three months)
versus chronic)
• Sport participation (athletes and/or military recruits versus
the general population)
We will inspect the overlap of confidence intervals and perform the
test for subgroup differences available in RevMan to test whether
subgroups are statistically significantly different from one another.
Sensitivity analysis
Where appropriate, we will perform sensitivity analyses investi-
gating the effects of risks of bias by excluding trials with high or
unclear risk of bias (such as for trials with lack of allocation con-
cealment and lack of random sequence bias) and trials reported
in abstracts only. Sensitivity analyses will also be performed to ex-
plore the differences between different models (fixed-effect versus
random-effects) for pooling data where there is heterogeneity. Fur-
thermore, we will perform sensitivity analysis for the trials with
imputed data.
’Summary of findings’ tables
Where there are sufficient data, we will summarise the results for
the main comparisons described in the Types of interventions in
’Summary of findings’ tables. We shall use the GRADE approach
to assess the quality of evidence related to each of the primary
outcomes listed in the Types of outcome measures (Higgins 2011;
see section 12.2).
ACKNOWLEDGEMENTS
We would like to acknowledge Helen Handoll and Nigel Han-
chard who provided valuable comments on the protocol. In addi-
tion, we are grateful to Joanne Elliott for her assistance with the
search strategies.
5
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∗
Indicates the major publication for the study

APPENDICES

Appendix 1. Search strategies

Central Register of Controlled Trials (Wiley Online Library)

#1 MeSH descriptor Patellofemoral Pain Syndrome, this term only
#2 MeSH descriptor Patella, this term only
#3 MeSH descriptor Knee Joint explode all trees
#4 MeSH descriptor Knee, this term only
#5 (#2 OR #3 OR #4)
#6 MeSH descriptor Arthralgia, this term only
#7 MeSH descriptor Pain explode all trees
#8 (#6 OR #7)
#9 (#5 AND #8)
#10 (anterior knee pain):ti,ab,kw
#11 (patell* or femoropatell* or femoro-patell* or retropatell*) NEAR/2 (pain or syndrome or dysfunction):ti,ab,kw
#12 ((lateral compression or lateral facet or lateral pressure or odd facet) NEAR/2 syndrome):ti,ab,kw
#13 (chondromalac* or chondropath* or chondrosis) NEAR/2 (knee* or patell* or femoropatell* or femoro-patell* or retropatell*):
ti,ab,kw
#14 MeSH descriptor Chondromalacia Patellae, this term only
#15 (#1 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14)
#16 MeSH descriptor Exercise Therapy explode all trees
#17 MeSH descriptor Exercise explode all trees
#18 (exercis* or strengthen* or stretch* or train* or physiotherapy or physical therap*):ti,ab,kw
#19 (#16 OR #17 OR #18)
#20 (#9 AND #15 AND #19)

Exercise for treating patellofemoral pain syndrome (Protocol) 7

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
MEDLINE (Ovid Online)
1 Patellofemoral Pain Syndrome/
2 Patella/ or exp Knee Joint/ or Knee/
3 Arthralgia/ or Pain/
4 2 and 3
5 anterior knee pain.tw.
6 ((patell* or femoropatell* or femoro-patell* or retropatell*) adj2 (pain or syndrome or dysfunction)).tw.
7 ((lateral compression or lateral facet or lateral pressure or odd facet) adj2 syndrome).tw.
8 ((chondromalac* or chondropath* or chondrosis) adj2 (knee*1 or patell* or femoropatell* or femoro-patell* or retropatell*)).tw.
9 Chondromalacia Patellae/
10 or/1,4-9
11 exp Exercise Therapy/ or exp Exercise/
12 (exercis* or strengthen* or stretch* or train* or physiotherapy or physical therap*).tw.
13 or/11-12
14 Randomized controlled trial.pt.
15 Controlled clinical trial.pt.
16 randomized.ab.
17 placebo.ab.
18 Drug Therapy.fs.
19 randomly.ab.
20 trial.ab.
21 groups.ab.
22 or/14-21
23 exp Animals/ not Humans/
24 22 not 23
25 and/10,13,2

CONTRIBUTIONS OF AUTHORS
RAH: searched studies to contextualise the background section, revised the protocol and approved the final version.
NEL: searched studies to contextualise the background section, revised the protocol and approved the final version.
RL: conceived the review, drafted the protocol and approved the final version.
SB-Z: conceived the review, drafted the protocol and is the guarantor of the review.
MM: conceived the review, drafted and revised the protocol, co-ordinated the protocol and approved the final version.

DECLARATIONS OF INTEREST
None known.

Exercise for treating patellofemoral pain syndrome (Protocol) 8

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
SOURCES OF SUPPORT

Internal sources
• Erasmus Medical Center, Netherlands.

External sources
• No sources of support supplied

Exercise for treating patellofemoral pain syndrome (Protocol) 9

Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.