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Open access Protocol

Rotator cuff-­related shoulder pain: does


the type of exercise influence the
outcomes? Protocol of a randomised
controlled trial
Marc-­Olivier Dubé ‍ ‍,1,2 François Desmeules,3,4 Jeremy Lewis,5,6,7
Jean-­Sébastien Roy1,2

To cite: Dubé M-­O, ABSTRACT


Desmeules F, Lewis J, et al. Strengths and limitations of this study
Introduction Lifetime prevalence of shoulder pain is 70%,
Rotator cuff-­related shoulder and approximately 50% of people with shoulder pain will
pain: does the type of exercise ►► This randomised controlled trial directly compares
experience pain for more than a year. Rotator cuff-­related
influence the outcomes? three of the most widely used interventions for rota-
shoulder pain (RCRSP) is the most common shoulder condition
Protocol of a randomised tor cuff-­related shoulder pain (education, strength-
controlled trial. BMJ Open and the main non-­surgical intervention is exercise therapy.
ening and motor control exercises) to highlight the
2020;10:e039976. doi:10.1136/ For approximately 30% of people with RCRSP, this approach
most efficient and guide shoulder rehabilitation.
bmjopen-2020-039976 does not lead to a significant reduction in symptoms. This
►► Effects on symptoms, kinesiophobia, catastrophisa-
may be due to an inappropriate dosage or choice of exercises.
►► Prepublication history and tion, acromiohumeral distance and tendon thickness
The aim of this investigation is to compare the short, mid and
additional material for this paper of different exercise programmes as well as educa-
long-­term effects, in terms of symptoms, functional limitations,
is available online. To view these tion will be analysed.
files, please visit the journal kinesiophobia and pain catastrophising, of three different
►► Methods to reduce the risk of bias will be imple-
online (http://​dx.​doi.​org/​10.​ shoulder rehabilitation approaches (education, strengthening,
mented throughout the study, which includes a
1136/​bmjopen-​2020-​039976). motor control) in adults with RCRSP.
statistically justified sample size, blinding, randomi-
Methods and analysis In this single-­blind (assessor), parallel-­
Received 04 May 2020
sation and adequate concealment of group alloca-
group, randomised clinical trial, 123 adults presenting with
Revised 22 September 2020 tion for the assessors.
RCRSP will take part in a 12-­week rehabilitation programme.
Accepted 16 October 2020 ►► Patients will be blinded to the treatment provided to
They will be randomly assigned to one of three groups
the other groups as it is not feasible to completely
(education only, strengthening approach or motor control-­
blind the participants and the treating therapist due
focused approach). Abbreviated version of the Disabilities of the
to the nature of the allocated treatments.
Arm, Shoulder and Hand Questionnaire, the primary outcome,
►► A true control group (wait-­and-­see approach) will
Western Ontario Rotator Cuff Index and Brief Pain Inventory will
not be included as it would be difficult to maintain a
evaluate symptoms and functional limitations, while Tampa
high retention and avoid cointerventions during the
Scale of Kinesiophobia and Pain Catastrophizing Scale will
mid-­term and long-­term follow-­up.
evaluate pain-­related fear and catastrophising at baseline and
at 3, 6, 12 and 24 weeks. Ultrasonographic acromiohumeral
distances and tendon thickness will be assessed at baseline
and 12 weeks. Intervention groups will be compared on up to 70%.1 The overall prognosis is highly vari-
outcomes with intention-­to-­treat analyses using two-­way able, with up to 50% of patients still reporting
repeated measures analysis of variance if the data are normally persistent pain 6–12 months after seeking an
distributed or non-­parametric analysis of longitudinal data if initial primary care consultation.1 Rotator cuff-­
they are not. related shoulder pain (RCRSP), a broad term
Ethics and dissemination Ethics approval was obtained from that includes rotator cuff tendinopathy, tendi-
the Sectorial Rehabilitation and Social Integration Research nitis, tendinosis, partial and atraumatic full-­
Ethics Committee of the Centre Intégré Universitaire de Santé
© Author(s) (or their thickness rotator cuff tears, impingement and
employer(s)) 2020. Re-­use et de Services Sociaux de la Capitale Nationale (CIUSSS-­CN).
subacromial pain, accounts for 50%–85% of
permitted under CC BY-­NC. No Results will be disseminated through international publications
in peer-­reviewed journals, in addition to international diagnoses for shoulder pain.2
commercial re-­use. See rights
and permissions. Published by conference presentations. Several interventions are available for RCRSP
BMJ. Trial registration number NCT03892603; pre-­results. such as education, exercise, manual therapy,
For numbered affiliations see electrotherapy, injection, medication and
end of article. surgery. Clinical trials suggest that the long-­term
INTRODUCTION outcomes of patients pharmacologically or surgi-
Correspondence to
Dr Jean-­Sébastien Roy; Shoulder pain is one of the most frequent cally treated are comparable to those receiving
​jean-​sebastien.​roy@​fmed.​ musculoskeletal (MSK) complaints in the rehabilitation.3–6 Regardless of modality, treat-
ulaval.​ca general population with a lifetime prevalence of ment is unsuccessful for more than one-­third of

Dubé M-­O, et al. BMJ Open 2020;10:e039976. doi:10.1136/bmjopen-2020-039976 1


Open access

patients who continue to have pain and disability following Objective and hypotheses
care.7 Several reasons may explain this lack of effectiveness The primary objective of this randomised controlled trial
and include psychosocial factors (including kinesiophobia7 (RCT) is to compare the short, mid and long-­term effects
and pain catastrophising8), occupational factors, lifestyle of three different approaches (education, strengthening,
factors,9 lack of adherence to the exercise programme,3 motor control) of delivering shoulder management on the
low expectations regarding recovery and low levels of self-­ symptoms and functional limitations of individuals with
efficacy.4 5 Other reasons behind this lack of success might be RCRSP. A secondary objective is to explore the effects of the
inadequate choice of exercise. programmes on shoulder control (acromiohumeral distance
Education and exercises are two of the most frequently (AHD)), subacromial structures (supraspinatus (SS) and
used interventions for RCRSP with evidence supporting infraspinatus (IS) tendon thickness), kinesiophobia and
their effectiveness.6 10 11 Patient education often constitutes catastrophisation related to shoulder pain. The hypothesis is
the first management strategy in health-­related conditions that both exercise groups will demonstrate a better outcome
as it does not necessitate extensive resources and is avail- in pain and function compared with the education group.
able to all. It helps reduce false beliefs and fears related to The motor control programme should lead to a quicker
the pathology as well as increase patient’s knowledge of their improvement in symptoms and functional limitations than
condition in order to improve their self-­efficacy.6 However, the strengthening programme because, by improving muscle
education alone might not be sufficient for all patients, as recruitment patterns, it will decrease control deficits and thus
some may present deficits such as muscular weakness or inhi- lower the odds of individuals experiencing pain. Its effect
bition, altered shoulder muscle recruitment patterns and on kinesiophobia should also contribute to a quicker rein-
kinematics.12 13 These deficits might explain the persistence tegration of movements into patients’ life, hence improve
of symptoms in some patients. Recent systematic reviews function. Finally, all groups should lead to a decrease in kine-
strongly recommend with low to moderate quality evidence siophobia and pain catastrophisation, but the motor control
that exercises be prioritised as a first-­line intention treatment and strengthening groups should lead to a greater reduc-
since it presents better outcome on pain and function than tion since participants will be guided to move in amplitudes
placebo or wait-­and-­see.14 15However, we still do not know that were previously limited by pain or pain-­related fears or
which types of exercise are better and thus lead to better perform near-­maximal intensity muscle contractions.
outcomes.13 There is even some evidence in the literature
suggesting that some types of exercise may not be more effec-
tive than a placebo.16 17 These findings highlight the need for METHODS AND ANALYSIS
higher quality studies evaluating the effect of different exer- Study design
cises for RCRSP. This single-­blind, parallel-­group RCT will include five evalua-
Motor control exercises have been shown to reduce pain tion sessions over 24 weeks (baseline, 3, 6, 12 and 24 weeks), six
and disability in individuals with RCRSP.10 One rationale intervention sessions over 12 weeks for both exercise groups
behind these effects is that improving muscle recruitment and two education sessions over 12 weeks for the education
patterns and kinematics could prevent the compression of group (figure 1). All participants will take part in the baseline
the subacromial soft tissues underneath the coracoacro- evaluation. They will complete self-­administered question-
mial arch as the arm elevates.12 Apart from this poten- naires on sociodemographic characteristics, symptomatology,
tial explanation that is still debated,2 efficiency of motor comorbidities, functional limitations, kinesiophobia and pain
control exercises might reside in the reduction of fear-­ catastrophising using self-­ reported questionnaires. Then,
avoidance behaviour or pain catastrophising as the patients ultrasonographic (US) measurements of the AHD and of the
are encouraged to move in previously feared positions.18 It SS and IS tendon thickness will be conducted. Thereafter,
could also have a direct neurophysiological central effect participants will be randomly assigned to one of three inter-
on pain-­related brain areas, similar to the one observed vention groups, and take part in their assigned programme.
with manual therapy,19 20 and bring change in pain sensi- All study outcomes will be reevaluated at 12 weeks, while the
tivity and sensorimotor processing. On the other hand, by self-­administered questionnaires will also be readministrated
progressively loading contractile tissue, strengthening exer- at 3, 6 and 24 weeks using web-­based questionnaires. A global
cises have been shown to decrease pain and muscle weak- rating of change question will be completed at 3, 6, 12 and 24
ness.11 This could be the result of an increased capacity by weeks. The study will be conducted at the Centre interdisciplin-
the tendon to sustain load or to a decrease in rotator cuff aire de recherche en réadaptation et en intégration sociale. This RCT
tendon inhibition.21 is registered on ​ClinicalTrials.​gov and the Standard Protocol
Although their clinical usefulness has already been assessed Items: Recommendations for Interventional Trials checklist
separately,22 23 no study has directly compared those three was used when writing the protocol.24
interventions for the management of RCRSP in order to
better highlight recovery over time as well as the choice of Participants and sample size
intervention provided. Identifying the most effective and effi- Adults presenting with RCRSP will be recruited using the
cient intervention(s) for RCRSP is of paramount importance following inclusion criteria: (1) 18–75 years of age, (2) symp-
to prevent symptoms persistence, limit healthcare costs asso- toms lasting longer than 3 months, (3) presence of a painful
ciated with these disorders and all resulting consequences. arc in flexion or abduction, (4) presence of a positive Neer

2 Dubé M-­O, et al. BMJ Open 2020;10:e039976. doi:10.1136/bmjopen-2020-039976


Open access

Figure 1 Schematic diagram of the study design. AHD, acromiohumeral distance; BPI, Brief Pain Inventory; GRC, global rating
of change; IST, infraspinatus tendon; PCS, Pain Catastrophizing Scale; QuickDASH, abbreviated version of the Disabilities of
the Arm, Shoulder and Hand Questionnaire; RCRSP, rotator cuff-­related shoulder pain; SST, supraspinatus tendon; TSK, Tampa
Scale of Kinesiophobia; WORC, Western Ontario Rotator Cuff Index.

sign or Hawkins-­Kennedy Test, (5) presence of pain when movement of at least 30% for two or more directions), severe
resisting humeral external rotation or abduction, or posi- osteoarthritis, fracture, dislocation, severe acromioclavicular
tive Jobe Test, and (6) ability to speak English or French. A joint pathology, (3) previous shoulder surgery, (4) presence
positive cluster of criteria 3, 4 and 5 represents an adequate of significant comorbidity, for example, neurological disor-
diagnostic tool for RCRSP (sensitivity: 0.75, specificity: ders, rheumatoid arthritis, (5) current or past carcinoma, (6)
0.74).25 Participants will be excluded if they present any of unlikely to be able to perform required clinical assessment
the following criteria: (1) clinical signs of massive rotator cuff tasks or attend the required evaluation and intervention
tears as defined by presence of gross weakness in the absence sessions, (7) symptomatic cervical spine pathology, defined as
of limited pain, (2) other shoulder disorders, for example, reproduction of symptoms with active physiological cervical
adhesive capsulitis (restriction of passive glenohumeral spine movements, and (8) corticosteroid injection in the last

Dubé M-­O, et al. BMJ Open 2020;10:e039976. doi:10.1136/bmjopen-2020-039976 3


Open access

6 weeks. All recruited participants will be evaluated by a phys- ►► The relevance of pain.
iotherapist (PT) in order to confirm their eligibility. ►► Pain management (night and day).
Based on our sample size calculation, calculated for our ►► Activity modification (when to increase and decrease).
primary outcome (abbreviated version of the Disabilities of ►► Reassurance.
the Arm, Shoulder and Hand Questionnaire (QuickDASH)),
41 participants are required per group (G*Power V.3.1.9; Shoulder muscle strengthening programme
effect size: 0.80, α=0.05, power=0.95, SD=13 DASH points, In addition to the same advice and education the control
clinically important difference (CID)=11 DASH points, group receives, participants from this group will be given a
expected lost at follow-­up=15%). Therefore, 123 participants shoulder progressive strengthening exercises programme
with RCRSP will be recruited. This sample size should be (online supplemental file 1) based on one-­ repetition
sufficient to detect a CID between groups. maximum (RM) that will involve concentric and eccentric
Potential participants will be recruited in outpatient physio- contractions with free weights and resistance elastic tubes.
therapy clinics of hospitals and in private physiotherapy clinics Exercises will target humeral internal/external rotators and
in the Quebec City region, and through electronic mailing abductors and the scapular muscles (protractors, retractors,
lists of employees and students at Université Laval (>52 000 elevators and depressors). Number of repetitions will be one
individuals). Since our research team has performed studies set of the maximum number of repetitions until muscular
evaluating the same population in the same metropolitan exertion or until pain reaches 3/10. If the pain level is 3/10
area, we are confident to recruit the targeted population.26–28 or more at rest, participants will be asked to start with a lower
With an average rate of seven new participants per month, we number of repetitions and increase or decrease depending
estimate that 18 months will be ample time to reach our goal on their pain behaviour in the following hours and the
of 123 participants. next day. Participants will be asked to complete the exer-
cises every day for 12 weeks. At each session with the PT (six
Randomisation and blinding over a 12-­week period), shoulder movements and strength
A randomisation list has been generated prior to the initia- will be reassessed, and the programme will be progressed
tion of the study by an independent research assistant not accordingly. The necessary equipment (dumbbells, elastic
involved in data collection using a random number gener- bands) will be provided to the participants. Any questions or
ator. Allocation is concealed in sealed and opaque envelopes concerns will also be addressed by the treating PT, and partic-
that are sequentially numbered. Randomisation was stratified ipants will be requested to complete a daily diary of their
to ensure balance of the treatment groups with respect to sex exercise adherence.
(male/female) and age (18–55/55–75). A blocked randomi-
sation was also used to make sure that three equal groups of Motor control and functional rehabilitation exercise programme
41 participants will be obtained (random blocks of 3, 6 or 9). Participants will receive the same advice and education as the
Given that it is impossible to blind the treating PT and partic- other groups as well as a motor control exercises programme
ipants, a single-­blind design will be used. To reduce potential (online supplemental file 2). Each session with the PT (six
contamination bias, the three programmes will be given at over a 12-­week period) will start with a pain neuromodulatory
different time periods. Further, participants will be instructed (motor control) technique in order to look at the influence of
not to discuss their group assignment, exercises performed different corrections to alleviate symptoms during upper limb
or advice received with other potential participants and with movements. A series of quick clinical tests will be conducted
the evaluator. To evaluate the effectiveness of blinding at the taking no more than 3 min. The tests will be performed in a
3-­month follow-­up, the evaluator will answer the following sequential format through three key areas: thoracic ‘finger
question: What intervention do you think the participant received?; on sternum technique’, scapular facilitation and ‘humeral
with one of the following answers: (1) education and advice, head’ procedures.29 30 If a technique reduces pain, that tech-
(2) strengthening, (3) motor control, or (4) no idea. If they nique will then be performed as exercises and incorporated
answer 1, 2 and 3, they will have to explain why they think the into the participant’s functional movement. In addition,
participant received this intervention. motor control exercises during arm elevation, progressed
Interventions through a standardised six-­phase retraining sequence, will be
Advice and education programme executed.26 31–33 Retraining phases will be graded according
During two education sessions of 30 min each, partic- to: (1) resistance applied to the shoulder; and (2) use or non-­
ipants will be given written information by a PT about the use of feedback. Once participants have reached pain-­free
shoulder (anatomy and function), basic pain science and execution, the programme will be progressed into re-­educa-
will be directed to watch a series of six educational videos on tion exercises according to the participants’ work, sports and
shoulder pain and function, persistent pain, physical activity, activities of daily living and incorporate a series of functional
stress, sleep and eating habits. For each video, they will have activities involving the whole body. Number of repetitions will
two questions to answer: (1) What was the most important vary from one to three sets of 10–30 repetitions. Participants
message? and (2) Was there anything you didn’t under- will be asked to complete the exercises every day. The neces-
stand in the video? The comprehensive written information sary equipment (dumbbells, elastic bands) will be provided
includes advice on: to the participants. Participants will be requested to complete
►► The shoulder and their condition. a daily diary of their exercise adherence.

4 Dubé M-­O, et al. BMJ Open 2020;10:e039976. doi:10.1136/bmjopen-2020-039976


Open access

Both exercise groups will be given information about pain superior iliac spine. Measures will be obtained with the
related to the execution of their exercise programme (online transducer perpendicularly, 1 cm behind to the anterolat-
supplemental file 3). eral aspect of the surface of the acromion. The thickness of
the SS tendon borders will be defined inferiorly as the first
Data collection hyperechoic region above the anechoic articular cartilage of
An evaluator blinded to group assignment will perform all the humeral head, and the hyperechoic superior border of
evaluations according to standardised procedures. the tendon before the anechoic subdeltoid bursa. IS tendon
Symptoms and functional limitations will be evaluated using thickness will be measured at the level of the posterior
the QuickDASH (generic questionnaire assessing any upper border of the acromion with the hand placed on the oppo-
limb disorders), the primary outcome, as well as two other vali- site shoulder. The thickness of the IS tendon borders will
dated self-­reported questionnaires: Western Ontario Rotator be defined inferiorly as the first hyperechoic region above
Cuff Index (WORC; specific to RCRSP) and the Short Form the anechoic articular cartilage of the humeral head, and
of Brief Pain Inventory (BPI-­SF). The QuickDASH is a self-­ the hyperechoic superior border of the tendon. These US
reported questionnaire that includes 11 items measuring tendon measures have been shown reliable (ICC >0.92).40
physical disability and symptoms of the upper extremity. It
presents excellent reliability, is responsive to change, has a Withdrawal of individual participants
minimal detectable change (MDC) and CID around 11%.34 All dropouts and their underlying reasons will be reported.
The WORC is a disease-­specific questionnaire developed to Principles underlying ‘intention-­ to-­
treat’ analysis will be
measure pain, function and health-­related quality of life of followed, meaning that every participant will be analysed
individuals suffering from RCRSP. It contains 21 items divided according to the randomised treatment assignment. There-
into five sections: physical symptoms, sports/recreation, fore, non-­ compliance, protocol deviation and withdrawal
work, lifestyle and emotions. It has demonstrated excellent will all be ignored in the primary analyses. Additionally, ‘per-­
reliability, is responsive to change for patients with RCRSP, protocol’ analysis (ie, the analysis will be restricted to partic-
has an MDC around 12% and a CID varying from 12% to ipants who adhered to the intervention as stipulated in the
13%.35 Finally, the BPI-­SF is a validated questionnaire used protocol) will also be performed. To ensure appropriate
to assess the intensity of pain and the interference of pain insight of mechanisms underlying changes in symptoms
on the patient’s life. It has shown to be reliable, internally and function, only participants who completed evaluation at
consistent over time and valid with several musculoskeletal week 12 will be considered for the US-­based outcomes. Any
populations including RCRSP.36 harm or unintended effects during the interventions will be
Pain-­related fear and catastrophising: The Tampa Scale of Kine- recorded. If a participant presents with an adverse event, the
siophobia (TSK) is a self-­ administered questionnaire that primary investigator will report it to the Ethics Committee.
measures beliefs and behaviours related with pain, specially
focusing on beliefs that pain is damaging and painful move-
ments should be avoided.37 The psychometric properties of Data integrity and analysis
the TSK have been confirmed for different pain disorders.38 All collected data will be accessible only to the research
The Pain Catastrophizing Scale is a self-­administered ques- team. All data will be kept for 5 years after the end of the
tionnaire measuring the range of catastrophic thoughts and study to ensure the completion of planned publications.
feelings (magnified threat, ruminating thoughts and feelings After this period, all data will be destroyed. A Data Moni-
of helplessness) associated with pain that individuals may toring Committee is not necessary as this trial is low risk. The
experience. High internal reliability has been reported in research team has opted not to undertake interim analysis.
patients with chronic pain with adequate validity and test–
retest reliability.39 Statistical analyses
US measurement of AHD and SS and IS tendonswill be assessed Descriptive statistics will be used for all outcome measures
with a 12 MHz linear array probe (Logic e9, GE Healthcare, at each measurement time to summarise results. Baseline
Milwaukee, Wisconsin, USA). US images of AHD will be demographic data will be compared (independent t-­tests and
obtained with the participants seated in a standardised posi- χ2 tests) to establish the comparability of groups. All data will
tion with the arm at rest and at 60° of active abduction. US be tested to check the distributional assumptions for infer-
measures will be obtained by placing the transducer on the ential statistical analyses. If data are normally distributed, a
anterior aspect of the lateral surface of acromion along the two-­way repeated measures analysis of variance (three inter-
longitudinal axis of the humerus in a frontal plane. The AHD ventions (control or strengthening or motor control) × 5
will be measured using the built-­in electronic calliper option times (0, 3, 6, 12 and 24 weeks)) will be used to analyse and
by manually locating the superior aspect of the humeral head compare the effects of the three programmes on primary
and the inferior aspect of acromion and then measuring outcome (QuickDASH) as well as secondary outcomes (three
the shortest linear distance between those two landmarks. interventions (control or strengthening or motor control)× 2
For each upper limb position, three measurements will be times (0 and 12 weeks) for the US-­based outcomes). Analyses
taken (intraclass correlation coefficient (ICC): 0.98; MDC: will be made using non-­parametric analysis of longitudinal
0.7 mm).40 Thickness of the SS tendon will be obtained with data package (R software) if parametric criteria are not met
the medial aspect of the wrist against the ipsilateral anterior since it is not possible to assume that the covariance matrix

Dubé M-­O, et al. BMJ Open 2020;10:e039976. doi:10.1136/bmjopen-2020-039976 5


Open access

is a compound-­symmetry matrix. For the multiple compari- Services Sociaux de la Capitale Nationale (CIUSSS-­CN)
sons, Bonferroni post hoc test will be used. Alpha level was (No 2019-1762).
set at 0.05.
Consent
Patient and public involvement Detailed information about the research and experi-
This research was done without patient involvement. Patients mental procedures will be provided to all participants
were not invited to comment on the study design and were before signature of the written informed consent. Partic-
not consulted to develop patient-­relevant outcomes. Patients ipants will be requested to sign a detailed informed
will not be invited to contribute to the writing or editing of consent before starting any experimental procedure
this document for readability or accuracy. (online supplemental file 4).

Confidentiality
All research team members will respect the data confi-
DISCUSSION dentiality of the patients, in agreement with the law.
It is essential to develop and identify effective interventions Patients’ names will be coded to keep their identity confi-
for the management of shoulder pain since it may become dential; however, a list of names and respective codes will
chronic and lead to adverse consequences such as decreased be stored in a locked and filing cabinet. All information
participation and quality of life, absenteeism at work, early collected during the study, including test results, will be
retirement, multiple medical consultations as well as high treated as confidential. The trial data set will be accessible
associated health costs. As stated earlier, up to 30% of indi- only to the research team and the Ethics Committee of
viduals with RCRSP still present pain and disability after reha- the CIUSSS-­CN for the purposes of management or audit
bilitation interventions such as rehabilitation exercises. A of research development. Publications related to these
recent study conducted by our research team showed that a data will respect all principles of confidentiality.
rehabilitation programme comprising mainly motor control
exercises led to fewer than 15% of individuals showing unsatis- Dissemination
factory results.26 In order to further decrease this percentage, Results of this protocol will be disseminated through
we have attempted to compare different optimized exercise international publication in peer-­ reviewed journals,
programmes. We have added exercises targeting the whole in addition to international conference presentations.
body, not only the shoulder, to our motor control programme Participants, clinicians and relevant research staff in the
because we believe it is essential to involve the whole body field will be informed about the results of the study.
since deficits in trunk or lower limb capacity may overload
the upper limb during activities of daily living. On the other Author affiliations
1
hand, multiple studies have shown promising results from Department of Rehabilitation, Faculty of Medicine, Université Laval, Quebec City,
Quebec, Canada
strengthening programmes primarily targeting shoulder 2
Center for Interdisciplinary Research in Rehabilitation and Social Integration,
abductors and external rotators.2 We believe that adding Quebec City, Quebec, Canada
strengthening exercises for other shoulder muscles such as 3
School of Rehabilitation, Faculty of Medicine, University of Montreal, Montreal,
scapular muscles could lead to even better results. Quebec, Canada
4
A true control group (wait-­and-­see approach) will not Maisonneuve-­Rosemont Hospital Research Centre, Montreal, Quebec, Canada
5
School of Health and Social Work, University of Hertfordshire, Hatfield, UK
be included as it would be difficult to maintain a high 6
Therapy Department, Central London Community Healthcare NHS Trust, London,
retention and avoid cointerventions during the mid-­term UK
and long-­term follow-­up. We also chose not to include a 7
Department of Physical Therapy & Rehabilitation Science, College of Health
placebo group, as it is hard to have a real placebo for this Sciences, Qatar University, Doha, Qatar
type of study and it is not really ethically fair for the partic-
Twitter Marc-­Olivier Dubé @marco_dube
ipants given that they will be followed for the 6 months
and that the exercises used in the programmes have been Contributors MOD contributed to conception, design and preparation of the
procedures, and data collection, and will conduct the recruitment, interventions,
shown to be superior to placebo.14 interpretation, data analyses and writing. FD and JSR contributed to study design,
Defining more efficient rehabilitation regimens for statistical analysis and interpretation of the data. JL contributed to conception,
common conditions such as RCRSP is important as it may design and preparation of the procedures. All authors commented on the study
lead to a reduction in associated costs. Therefore, the protocol and approved its final version.
present study will establish the effectiveness of these two Funding This work was supported by the Quebec Rehabilitation Research
programmes and determine if one is more effective than Network (REPAR). MOD received a Master’s Training Scholarship from the Fonds de
Recherche Québec-­Santé (FRQS). JSR and FD are supported by salary awards from
the other or more effective than education. the Canadian Institutes of Health Research (CIHR).
Competing interests None declared.
Patient consent for publication Obtained.
ETHICS Provenance and peer review Not commissioned; externally peer reviewed.
Ethics approval was obtained from the Sectorial Rehabili- This content has been supplied by the author(s). It has not been vetted by BMJ
tation and Social Integration Research Ethics Committee Publishing Group Limited (BMJ) and may not have been peer-­reviewed. Any
of the Centre Intégré Universitaire de Santé et de opinions or recommendations discussed are solely those of the author(s) and are

6 Dubé M-­O, et al. BMJ Open 2020;10:e039976. doi:10.1136/bmjopen-2020-039976


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not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any 18 Vaegter HB, Madsen AB, Handberg G, et al. Kinesiophobia is
reliance placed on the content. Where the content includes any translated material, associated with pain intensity but not pain sensitivity before and after
BMJ does not warrant the accuracy and reliability of the translations (including but exercise: an explorative analysis. Physiotherapy 2018;104:187–93.
19 Roy J-­S, Bouyer LJ, Langevin P, et al. Beyond the joint: the role of
not limited to local regulations, clinical guidelines, terminology, drug names and
central nervous system reorganizations in chronic musculoskeletal
drug dosages), and is not responsible for any error and/or omissions arising from disorders. J Orthop Sports Phys Ther 2017;47:817–21.
translation and adaptation or otherwise. 20 Ellingson LD, Stegner AJ, Schwabacher IJ, et al. Exercise
Open access This is an open access article distributed in accordance with the strengthens central nervous system modulation of pain in
Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which fibromyalgia. Brain Sci 2016;6:8.
21 Michener LA, Subasi Yesilyaprak SS, Seitz AL, et al. Supraspinatus
permits others to distribute, remix, adapt, build upon this work non-­commercially, tendon and subacromial space parameters measured on
and license their derivative works on different terms, provided the original work is ultrasonographic imaging in subacromial impingement syndrome.
properly cited, appropriate credit is given, any changes made indicated, and the use Knee Surg Sports Traumatol Arthrosc 2015;23:363–9.
is non-­commercial. See: http://​creativecommons.​org/​licenses/​by-​nc/​4.​0/. 22 Savoie A, Mercier C, Desmeules F, et al. Effects of a movement
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