PhysiOtherapist-led Exercise Versus Waiting-list Control for patiEnts Awaiting Rotator Cuff Repair Surgery: a Pilot Randomised Controlled Trial
Phase: NA
Conditions: Rotator Cuff Tears
Sponsor: University Hospitals of Derby and Burton NHS Foundation Trust

 
 
 
POWER_v1.0_08 Jun 2021 
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PhysiOtherapist-led exercise versus Waiting-list control for patiEnts awaiting Rotator cuff repair 
surgery: a pilot randomised controlled trial with nested qualitative study 
Acronym: POWER 
 
Version and Date of 
Protocol: 
 
v1.0_08 Jun 2021 
Sponsor:  
University Hospitals of Derby and Burton NHS Foundation Trust 
(UHDB) 
Chief Investigator: 
Chris Littlewood 
Local Study Reference: 
UHDB/2021/016 
IRAS Number: 
 
295809 
ISRCTN/ ClinicalTrials.gov 
number: 
 
NCT04974242 
Funder(s): 
National Institute for Health Research 
Post-Doctoral Fellowship Scheme 
Email: academy@nihr.ac.uk   
Tel: 0113 3466280 
 
This protocol has regard for the HRA guidance 
 
 
 
 

 
 
 
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Confidentiality Statement 
 
This document contains confidential information that must not be disclosed to anyone other than 
the Sponsor, the Investigator Team, host NHS Trust, regulatory authorities, and members of the 
Research Ethics Committee. 
 

 
 
 
POWER_v1.0_08 Jun 2021 
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SIGNATURE PAGE 
 
The undersigned confirm that the following protocol has been agreed and accepted and that the 
Chief Investigator agrees to conduct the study in compliance with the approved protocol and will 
adhere to the principles outlined in the Declaration of Helsinki, the Derby CTSU’s SOPs, and other 
regulatory requirement. 
I agree to ensure that the confidential information contained in this document will not be used for 
any other purpose other than the evaluation or conduct of the investigation without the prior 
written consent of the Sponsor. 
I also confirm that I will make the findings of the study publicly available through publication or 
other dissemination tools without any unnecessary delay and that an honest accurate and 
transparent account of the study will be given; and that any discrepancies from the study as planned 
in this protocol will be explained. 
 
Protocol v1.0_08 Jun 2021authorisation signatures: 
 
Chief Investigator: 
Signature: 
 
……………………………………………………….. 
 
Date: 08 / Jun / 2021 
 
Name (please 
print): 
Chris Littlewood 
……………………………………………………….. 
 
 
 

 
 
 
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KEY STUDY CONTACTS 
 
Chief Investigator: 
Prof. Chris Littlewood 
Faculty of Health, Psychology and Social Care 
Manchester Metropolitan University 
Brooks Building, 53 Bonsall Street, M15 6GX 
Email: c.littlewood@mmu.ac.uk    
Tel: 0161 247 5235 
Co-Investigator(s): 
Prof. Nadine Foster (n.foster@keele.ac.uk ) 
Dr Julia Wade (Julia.Wade@bristol.ac.uk ) 
Trial Manager/ Co-ordinator: 
Dan Davis (daniel.davis6@nhs.net) 
Derby Clinical Trials Support Unit 
Royal Derby Hospital 
Uttoxeter Road, Derby, DE22 3NE 
01332 724639 
Sponsor: 
Dr Teresa M. Grieve 
Assistant Director of Research & Development 
Director Derby Clinical Trials Support Unit 
Research & Development Department 
University Hospitals Derby & Burton NHS Foundation Trust 
University of Nottingham Medical School at Derby 
Royal Derby Hospital, Uttoxeter Road, Derby, DE22 3DT. 
Email:  uhdb.sponsor@nhs.net   
Tel. 01332 724710   
Funder(s): 
National Institute for Health Research 
Post-Doctoral Fellowship Scheme 
Email: academy@nihr.ac.uk    
Tel: 0113 3466280 
Clinical Trials Unit: 
Derby Clinical Trials Support Unit 
Royal Derby Hospital 
Uttoxeter Road, Derby, DE22 3NE 
Email: uhdb.DerbyCTSU@nhs.net  
Tel: 01332 724639 
Study Statistician: 
Jacqueline Beckhelling 
Derby Clinical Trials Support Unit 
Royal Derby Hospital 
Uttoxeter Road, Derby, DE22 3NE 
Email: jacqueline.beckhelling@nhs.net  
 

 
 
 
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STUDY SUMMARY 
 
Study Title: 
PhysiOtherapist-led exercise versus Waiting-list control for patiEnts 
awaiting Rotator cuff repair surgery: a pilot randomised controlled trial 
(POWER) 
Local Study Reference: 
UHDB/2021/016 
Study Design: 
Two-arm, parallel group, pilot randomised controlled trial (RCT) with 
integrated qualitative study 
Study Participants: 
Adults diagnosed with tears of the rotator cuff and awaiting elective 
surgical repair 
Planner Number of Sites: 
4 sites 
Planned Sample Size: 
76 
Treatment Duration: 
12 weeks 
Follow Up Duration: 
6 months 
Planned Start Date: 
1 September 2021 
Planned Recruitment End Date: 
28 February 2022 
Planned Study End Date: 
31 August 2022 
Research Question/ Aims: 
In adult patients diagnosed with tears of the rotator cuff and awaiting 
elective surgical repair, is it feasible to conduct a future, fully powered, 
multi-site RCT to test the hypothesis that physiotherapist-led exercise is 
superior to waiting-list control in terms of clinical and cost-effectiveness? 
 
FUNDING AND SUPPORT IN KIND 
 
Funder(s) 
Financial and Non-Financial Support Given 
National Institute for Health Research 
Post-Doctoral Fellowship Scheme 
Email: academy@nihr.ac.uk    
Tel: 0113 3466280 
Research grant: £533,072 
 

 
 
 
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ROLES & RESPONSIBILITIES 
Sponsor 
The Sponsor, UHDB, take on overall responsibility for appropriate arrangements being in place to set 
up, run and report the research project. The sponsor is not providing funds for this study but has 
taken on responsibility for ensuring finances are in place to support the research.  
 
Funder 
The study is funded by the National Institute for Health Research, Post-doctoral fellowship 
programme. 
 
Study Management Committees 
Trial Management Group 
The trial management group will meet regularly to oversee the day-to-day management of the trial, 
including all aspects of the conduct of the trial. Any problems with study conduct and participating 
centers will be raised and addressed during TMG meetings.  
 
Trial Steering Committee 
The trial steering committee will oversee and supervise the progress of the trial and ensure that it is 
being conducted according to the protocol and the applicable regulations. The TSC is an independent 
body that includes majority members who are not involved with the running of the trial.  
 
Protocol Contributors 
A number of protocol contributors have been involved in the development of this protocol, these 
include; the Chief Investigator (CL), Statistician (JB), Data Manager and Trial Manager, fellowship 
mentors (NF, JW). Protocol contributors are responsible for inputting into the design of the study, 
ensuring that it is designed transparently and efficiently.  

 
 
 
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Contents 
SIGNATURE PAGE .................................................................................................................................... 3 
KEY STUDY CONTACTS ............................................................................................................................ 4 
STUDY SUMMARY ................................................................................................................................... 5 
FUNDING AND SUPPORT IN KIND ........................................................................................................... 5 
ROLES & RESPONSIBILITIES ..................................................................................................................... 6 
LIST OF ABBREVIATIONS ......................................................................................................................... 9 
STUDY FLOW CHART ............................................................................................................................. 10 
1. 
BACKGROUND ............................................................................................................................... 11 
2. 
RATIONALE .................................................................................................................................... 11 
3. 
OBJECTIVES AND OUTCOME MEASURES/ ENDPOINTS ................................................................. 12 
3.1. 
Objectives.............................................................................................................................. 12 
3.2. 
Outcome ............................................................................................................................... 12 
4. 
STUDY DESIGN............................................................................................................................... 12 
5. 
STUDY SETTING ............................................................................................................................. 12 
6. 
ELIGIBILITY CRITERIA ..................................................................................................................... 12 
6.1. 
Inclusion Criteria ................................................................................................................... 12 
6.2. 
Exclusion Criteria ................................................................................................................... 12 
7. 
STUDY PROCEDURES ..................................................................................................................... 12 
7.1. 
Recruitment .......................................................................................................................... 12 
7.1.1. 
Patient Identification .................................................................................................... 12 
7.1.2. 
Screening ....................................................................................................................... 12 
7.2. 
Consent ................................................................................................................................. 13 
7.3. 
Randomisation ...................................................................................................................... 13 
7.4. 
Blinding ................................................................................................................................. 13 
7.5. 
Study Interventions ............................................................................................................... 14 
7.6. 
Study Assessments ................................................................................................................ 15 
7.7. 
Withdrawal Criteria ............................................................................................................... 18 
7.8. 
Integrated qualitative study .................................................................................................. 18 
7.8.1. 
Recruitment .................................................................................................................. 18 
7.8.2. 
Qualitative Data Collection ........................................................................................... 18 
7.8.3. 
Qualitative Data Analysis .............................................................................................. 18 
7.9. 
End of Study .......................................................................................................................... 19 
8. 
SAFETY REPORTING ....................................................................................................................... 20 
8.1. 
Definitions ............................................................................................................................. 20 
8.2. 
Operational Definitions for (S)AEs ........................................................................................ 20 
8.3. 
Recording and Reporting SAEs .............................................................................................. 20 
8.3.1. 
Assessment of AEs and SAEs ......................................................................................... 21 
8.4. 
Pregnancy reporting.............................................................................................................. 21 
8.5. 
Reporting Urgent Safety Measures ....................................................................................... 21 
9. 
DATA HANDLING ........................................................................................................................... 21 
9.1 
System and compliance ........................................................................................................ 21 
9.2 
Source Data ........................................................................................................................... 22 
9.3 
Workflow ............................................................................................................................... 22 
9.4 
 Data Access and Security ..................................................................................................... 22 
9.5 
Archiving ............................................................................................................................... 23 
10. 
STATISTICS AND DATA ANALYSIS .............................................................................................. 23 
10.1. 
Sample Size Calculation..................................................................................................... 23 
10.2. 
Planned Recruitment Rate ................................................................................................ 23 
10.3. 
Statistical Analysis ............................................................................................................. 23 

 
 
 
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10.3.1. 
Summary of Baseline Data and Flow of Patients .......................................................... 23 
10.3.2. 
Outcome Analysis.......................................................................................................... 24 
10.4. 
Subgroup Analyses ............................................................................................................ 24 
10.5. 
Adjusted analyses ............................................................................................................. 25 
10.6. 
Interim Analysis and Criteria for the Premature Termination of the Study ..................... 25 
10.7. 
Analysis Groups ................................................................................................................. 25 
10.8. 
Procedure(s) to Account for Missing or Spurious Data..................................................... 25 
11. 
MONITORING, AUDIT & INSPECTION ........................................................................................ 25 
12. 
ETHICAL AND REGULATORY CONSIDERATIONS ........................................................................ 25 
12.1. 
Assessment and Management of Risk .............................................................................. 25 
12.2. 
Peer review ....................................................................................................................... 25 
12.3. 
Public and Patient Involvement ........................................................................................ 25 
12.4. 
Research Ethics Committee (REC) & Regulatory Considerations...................................... 26 
12.5. 
Protocol Compliance/ Non-Compliance ........................................................................... 26 
12.6. 
Notification of Serious Breaches to GCP and/or the Protocol .......................................... 26 
12.7. 
Data Protection and Patient Confidentiality ..................................................................... 26 
12.8. 
Financial and Other Competing Interests for the Chief Investigator, Principal 
Investigators at Each Site and Committee Members for the Overall Study Management .............. 27 
12.9. 
Indemnity .......................................................................................................................... 27 
12.10. 
Amendments ..................................................................................................................... 27 
12.11. 
Access to Final Study Dataset ........................................................................................... 27 
13. 
DISSEMINATION POLICY ............................................................................................................ 27 
13.1. 
Dissemination Policy ......................................................................................................... 27 
14. 
REFERENCES .............................................................................................................................. 28 
15. 
APPENDICES .............................................................................................................................. 30 
15.1. 
Appendix 1 – The physiotherapist-led exercise programme ............................................ 30 
15.2. 
Appendix 1 - Amendment History..................................................................................... 32 
 
 

 
 
 
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LIST OF ABBREVIATIONS 
 
AE 
Adverse Event 
CI 
Chief Investigator 
CRF 
Case Report Form 
DMEC 
Data Monitoring and Ethics Committee 
GCP 
Good Clinical Practice 
ICF 
Informed Consent Form 
ISF 
Investigator Site File 
ISRCTN 
International Standard Randomised Controlled Trials  
NHS R&D 
National Health Service Research & Development 
PI 
Principal Investigator 
PIC 
Participant Identification Centre 
PIS 
Participant Information Sheet 
QA 
Quality Assurance 
QC 
Quality Control 
RCT 
Randomised Controlled Trial 
REC 
Research Ethics Committee 
SAE 
Serious Adverse Event 
SDV 
Source Data Verification 
SOP 
Standard Operating Procedure  
TMG 
Trial Management Group 
TSC 
Trial Steering Committee 
TMF 
Trial Master File 
 

 
 
 
POWER_v1.0_08 Jun 2021 
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STUDY FLOW CHART 
 
 
 
 
 
Adult patients diagnosed with rotator cuff tear awaiting elective surgical repair identified and provided with a cover letter and 
participant information sheet 
Completion of the electronic baseline questionnaire  
Online randomisation (n = 76) stratified by hospital site 
Physiotherapist-led exercise (n = 38). Structured and 
progressive physiotherapist-led exercise programme 
supported over an approximate 12-week period. The 
participant will continue on the waiting list unless they 
indicate that they wish to be removed.  
Waiting list control 
(n = 38). The patient remains on the waiting list as per 
usual care 
Follow-up via electronic questionnaire at 6 weeks, 3- and 6-months: Shoulder Pain and Disability Index (SPADI), EQ-5D-5L, days 
lost from work and driving, whether surgery has been performed or not, and, if not, whether the participant intends to undergo 
surgery, any adverse events, and healthcare resource use at 6-months only. Non-responders will be followed up via telephone 
or secure video platform 
Qualitative interviews with participants from both groups (up to 25 participants in total) after 6-month follow-up to explore 
reasons for participation, their experience of the trial, and treatment acceptability 
Follow up telephone call, meeting via secure video platform or in person with the local hospital site research staff, up to 10 
days later. If the potential participants are interested, confirmation of consent will be gained via audio-recording and confirmed 
in writing by the person responsible for gaining consent  
Decision whether a main trial is feasible with regards to pre-defined success criteria (in consultation with Trial Steering 
Committee) 

 
 
 
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STUDY PROTOCOL 
 
1. 
BACKGROUND 
Shoulder pain presents a significant personal, social and economic burden and impacts on work, 
ability to undertake leisure and household tasks and causes disturbed sleep (1). Tears of the rotator 
cuff are regarded as a significant cause of shoulder pain and rates of surgery to repair the torn 
rotator cuff have risen approximately 200% over recent years, from 1995 to 2011, across Europe and 
the USA (2–5). In the UK NHS, 8838 surgical repairs of the rotator cuff were undertaken in 
2018/2019 (6). Depending on complexity, the cost of surgical repair ranges from £3676 to £6419 (7) 
meaning that direct NHS treatment costs alone range from £32.5 to £56.7 million annually. 
 
Once a decision to undergo rotator cuff repair surgery has been made, most patients are placed on 
the elective surgery waiting list, and it can take weeks or months to receive the surgery. While the 
rates of surgery to repair the torn rotator cuff have risen over previous years, during the Covid-19 
pandemic, elective orthopaedic surgery has been affected dramatically, with many operations, 
including those to repair the rotator cuff, postponed with ongoing uncertainty about when ‘normal’ 
elective surgery might continue. This means that waiting times have increased significantly, causing 
a backlog of patients on waiting lists and creating a tremendous burden for patients and the NHS. It 
is also likely that the current waiting lists are not reflective of the full burden as some clinicians have 
opted not to place patients on the elective surgery waiting list at this time of great uncertainty. 
 
Two previous studies have evaluated the impact of physiotherapy on the need for surgery. One 
prospective cohort study in the USA, reported that 75% of patients with non-traumatic tears of the 
rotator cuff did not subsequently require surgery (8). A randomised controlled trial (RCT), in Sweden, 
evaluating the impact of physiotherapist-led exercise (9) on the need for subacromial decompression 
surgery for patients diagnosed with subacromial impingement syndrome, not rotator cuff tear, 
reported that 80% of participants did not subsequently require surgery. Cautiously extrapolating 
these data, if a programme of physiotherapist-led exercise (cost ranging from £115 to £204 per 
patient), delivered virtually while patients were on the surgical waiting list, resulted in 20% of 
patients not requiring rotator cuff repair surgery, for an outlay of £1 million to £1.8 million  (8 838 x 
£115 to £204), there would be considerable NHS treatment cost savings per year of £6.5 to £11.3 
million. If benefits to the individual patient and societal costs are added to this calculation, including 
work costs, this figure would rise considerably. Also, as the number of patients awaiting rotator cuff 
repair surgery continues to increase, this cost saving will increase further. 
 
2. 
RATIONALE 
While waiting for surgery, many patients continue to experience significant pain and disability, 
including difficulties with activities of daily living and self-care, difficulty sleeping (a particular 
problem for patients with shoulder pain), and some will continue to be unable to work and 
experience significant de-conditioning. Given current uncertainty about when elective surgery will 
re-start in many services, and how the backlog of patients might be managed, waiting times will 
simply increase. If treatment could be delivered to patients while on the waiting list with potential to 
reduce pain and disability, and also potentially reduce the need for surgery, there would be clear 
and significant patient benefit and also benefit to the NHS in terms of reducing the number of 
surgeries, meaning those patients with the greatest need for surgery will be able to get access to it 
more quickly. 
 
In this context, the POWER trial will address an important current NHS issue, is Covid-proof in 
design, and has potential for significant impact beyond the current pandemic. 
 
 

 
 
 
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3. 
OBJECTIVES AND OUTCOME MEASURES/ ENDPOINTS 
 
3.1. 
Objectives 
Research question: In adult patients diagnosed with tears of the rotator cuff and awaiting elective 
surgical repair, is it feasible to conduct a future, fully powered, multi-site RCT to test the hypothesis 
that physiotherapist-led exercise is superior to waiting-list control in terms of clinical and cost-
effectiveness? 
 
Objectives 
1) Estimate the numbers of eligible patients and rate of recruitment (Screened, Eligible, Approached, 
Randomised (SEAR)). 
2) Describe the reasons for not wanting to participate based on SEAR data. 
3) Report treatment fidelity with regards to the number of participants who receive physiotherapy, 
the number of appointments attended and self-report exercise adherence (intervention group only) 
4) Report the completion rate of outcome measures. 
5) Describe the number and nature of adverse events six-months following randomisation. 
6) Report the number and proportion of participants who report an intention to proceed to surgery 
or who have received surgery within six-months post randomisation. 
7) Barriers and facilitators to recruitment, retention and treatment acceptability (qualitative data). 
 
3.2. 
Outcome 
The primary outcome is to determine if the study is feasible based on the criteria in Section 10. 
 
4. 
STUDY DESIGN 
Pragmatic multi-centre, external pilot RCT with feasibility objectives using a parallel group design 
with 1:1 allocation ratio and integrated qualitative study. 
 
5. 
STUDY SETTING 
Orthopaedic and affiliated physiotherapy services at four NHS hospitals. Delivery of the intervention 
will be flexible including via secure video platform, for example NHS Attend Anywhere which is a 
secure web-based platform for patients with pre-arranged video consultation appointments, via 
telephone, or face-to-face, according to patient preference and safety. Remote delivery of a 
physiotherapy intervention for shoulder disorders has previously been reported as feasible and 
acceptable (10) and non-inferior to face-to-face provision (11). 
 
6. 
ELIGIBILITY CRITERIA 
6.1. 
Inclusion Criteria 
• 
Adult patients on the elective orthopaedic waiting list for surgical repair of the rotator cuff.  
 
6.2. 
Exclusion Criteria 
• 
Unable to provide informed consent. 
 
7. 
STUDY PROCEDURES 
7.1. 
Recruitment 
 
7.1.1. 
Patient Identification  
Potential participants will be identified from the elective surgical waiting lists by the local Principal 
Investigator (clinical) and local research staff at the hospital sites. 
 
7.1.2. 
Screening 
No further screening measures will be implemented. 
 

 
 
 
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7.2. 
Consent 
 
Once a potential participant is identified, a participant information sheet with cover letter (POWER 
RCT Participant Information Sheet) and consent form (POWER RCT Consent Form), will be provided. 
This will be followed up by a telephone call, meeting via secure video platform (according to local 
hospital site availability), or in person supported by a recruitment script (POWER Recruitment Script) 
from the local hospital research staff at the hospital sites, up to 10 days later. The study will be 
discussed and there will be an opportunity to ask questions. If the potential participant expresses an 
interest, confirmation of consent, in this non-CTIMP low-risk study, will be audio-recorded by the 
local hospital research staff asking the participant to confirm their name before reading each item of 
the consent form and asking them whether they consent or not. On completion of the consent 
discussion, the local research staff will sign and date the consent form, confirming that informed 
consent has been gained and a recording saved securely at the local hospital site, to confirm this. 
Once saved, the audio-recording would be immediately deleted from the recording device. A letter 
will also be sent to the participants’ GP confirming their involvement, if consent to do so is provided 
(POWER GP Letter). 
 
Informed consent will be obtained prior to the participant undergoing procedures that are 
specifically for the purposes of this study. The Principal Investigator (PI) retains overall responsibility 
for the informed consent of participants at their site and must ensure that any person delegated 
responsibility to participate in the informed consent process is duly authorised, trained and 
competent according to the REC approved protocol and applicable guidelines and regulations. 
 
7.3. 
Randomisation 
Upon confirmation of informed consent and completion of baseline assessment, individual 
participants will be randomly allocated via an online randomisation system set up by Derby Clinical 
Trials Support Unit to ensure allocation concealment. Randomisation will be 1:1 and stratified by 
hospital site. 
 
7.4. 
Blinding 
No measures to blind participants, clinicians, research team or oversight committees will be 
implemented. 
 
 

 
 
 
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7.5. 
Study Interventions 
Intervention: Structured and progressive physiotherapist-led exercise programme, delivered flexibly 
via secure video platform, for example NHS Attend Anywhere which is a secure web-based platform 
for patients with pre-arranged video consultation appointments, via telephone, or face-to-face, 
according to patient preference and safety.  Reflective of current guidance for exercise programmes 
for people with rotator cuff disorders, an individualised programme developed in relation to the 
participant’s specific goals will be prescribed by the physiotherapist and supported over 
approximately six contact sessions across a 12-week period. The exercise programme is based on the 
principle of self-dosing and is based on establishing the current functional capacity of the patient in 
relation to the most challenging shoulder movements. The development process and resultant 
programme of physiotherapist-led exercise has been reported (12) and is supported by a study-
specific exercise booklet (POWER exercise booklet) is provided to the patient, electronically or in 
paper form according to patient preference. Further detail is provided in Appendix 1.  
 
The exercise approach described here enables adaptation to the individual participant who, in the 
context of this POWER trial, are likely to present with quite different levels of exercise capacity at 
the outset. Following an initial consultation and exercise prescription, the patient will maintain 
responsibility for undertaking the exercise but will discuss with the physiotherapist, at individually 
negotiated and agreed time points over approximately six sessions across a 12-week time period, for 
follow-up self-management support and advice regarding exercise progression (13,14). Participants 
undertaking the physiotherapist-led exercise programme will continue on the waiting list for rotator 
cuff surgery unless they indicate that they wish to be removed. In this event, the surgical team will 
be notified by the local PI. 
 
Control: To continue on the waiting list for rotator cuff repair surgery, as per usual care. 

 
 
 
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7.6. 
Study Assessments 
To meet the study objectives, the following assessments at baseline and follow-up will be undertaken. The assessments will be via electronic questionnaires; 
baseline data will be inputted by local hospital research staff directly, and links to the follow-up questionnaires will be sent to the participants by text or 
email. Non-responders will be followed-up by local hospital research staff by telephone or secure video platform to enable minimal data collection. 
 
Baseline assessments 
Measure  
Description 
Patient descriptors 
 
Demographics 
Gender, date of birth, height, weight 
Duration of shoulder pain 
Patient self-report in months: 1 question 
Smoking status 
Patient self-report: 1 question (current tobacco smoker/ past tobacco smoker / current e-cigarette vaper / past e-
cigarette vaper/ never smoked or vaped) 
Diabetes 
Patient self-report: Yes/ No 
Employment 
Patient self-report: Current employment status: 1 question 
Previous physiotherapy for current 
shoulder problem 
Patient self-report: Yes/ No 
Preference 
for 
treatment 
intervention 
Patient self-report: 1 question with 3 options 
Clinical status 
 
Shoulder Pain and Disability  
Patient self-report: Shoulder Pain and Disability Index (SPADI) 13 items, 11 discrete responses per item 
Health related quality of life  
Patient self-report: EuroQol: EQ-5D-5L 
Diagnosis 
 
Size & location of rotator cuff tear (if 
available) 
Medical records: Size according to imaging (Ultrasound scan (USS) or MRI): 1 question with 5 options (small <1cm, 
medium ≥1 but <3cm, large ≥3 but <5cm, massive ≥5cm, not known).  
Location according to imaging (USS or MRI): 1 question with 5 options – more than one can apply (supraspinatus, 
infraspinatus, subscapularis, teres minor, not known) 
 
The SPADI is a patient self-report measure of shoulder pain and disability that has been validated for use over the telephone (15). The EQ-5D-5L is a generic 
measure of health related quality of life that provides a single index value for health status that can be used for the purpose of clinical and health economic 
evaluation (16). 
 
 

 
 
 
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Trial assessments 
Assessment 
Description 
Feasibility of recruiting patients 
Numbers of patients screened, number eligible, number approached, number randomised 
(SEAR)  
Barriers to recruitment 
Reasons for not wanting to participate based on SEAR data 
Follow-up rates 
Follow-up response rates to questionnaires at 6-weeks, three- and six-months post-
randomisation (including SPADI and EQ-5D-5L) 
Treatment fidelity 
Number of physiotherapy appointments attended and self-report exercise adherence 
(intervention group only) 
Barriers and facilitators to recruitment, retention and 
treatment acceptability 
Qualitative data (individual interviews at 6-months) 
 
Follow-up assessments 
Measure 
Description 
6 
weeks 
6 
weeks 
MDC 
3 
months 
3 months 
MDC 
6 
months 
6 months 
MDC 
Clinical status 
 
 
 
 
 
 
 
Shoulder Pain and Disability  
Via questionnaire: SPADI 13 items, 11 discrete responses 
per item 
✓ 
✓ 
 
✓ 
 
✓ 
 
✓ 
 
✓ 
 
Health related quality of life  
Via questionnaire: EuroQol: EQ-5D-5L 
✓ 
 
 
✓ 
 
✓ 
 
 
Exercise adherence 
Via questionnaire: To what extent do you agree with the 
following statement? 'I have been doing my exercises as 
often as prescribed.' (strongly agree/ agree/ not sure/ 
disagree/ strongly disagree) 
✓ 
 
 
✓ 
 
✓ 
 
 
Days lost from work (if 
applicable) 
Via questionnaire 
✓ 
 
✓ 
 
✓ 
 
Days lost from driving (if 
applicable) 
Via questionnaire 
✓ 
 
✓ 
 
✓ 
 

 
 
 
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Has surgery been performed 
yet? If not, is their intention 
still to proceed to surgery? 
Via questionnaire 
 
✓ 
 
✓ 
✓ 
✓ 
✓ 
✓ 
Adverse events 
Via questionnaire and clinician report 
✓ 
✓ 
✓ 
✓ 
✓ 
✓ 
Health Care Utilisation 
 
 
 
 
 
 
 
Health Care Resource Use 
Via questionnaire 
 
 
 
 
✓ 
 

 
 
 
POWER_v1.0_08 Jun 2021 
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7.7. 
Withdrawal Criteria 
 
Participants are free to withdraw from the study at any time during participant follow-up. The local 
site PI, study CI and Derby CTSU will make every effort to ensure that the specific wishes of any 
participant who wishes to withdraw consent for further involvement in the trial are defined and 
documented. Participants who wish to withdraw from the treatments will have the option to still 
receive follow-up questionnaires, if they are willing. 
 
7.8. 
Integrated qualitative study 
7.8.1. 
Recruitment 
Following the six-month follow-up point, a sample of patient participants will be purposively 
sampled from both treatment arms and interviewed to explore reasons for initial participation, their 
experience of the trial, and treatment acceptability, where relevant.  Where possible sampling will 
purposively include a range of patient experience/views as regards having received surgery, still 
awaiting surgery, and deciding surgery is no longer needed. 
 
Within the 6-month questionnaire, there will be an option to consent to contact for the purpose of 
discussing the qualitative study. If consent to contact is gained, a participant information sheet 
(POWER Qualitative Participant Information Sheet) and consent form (POWER Qualitative Consent 
Form), will be forwarded. The CI will subsequently contact the patient, via telephone, to discuss 
involvement in an individual qualitative interview. If the patient expresses interest, confirmation of 
consent will be recorded by the CI asking the participant to confirm their name before reading each 
item of the consent form and asking them whether they consent or not. On completion of the 
consent discussion, the CI will sign and date the consent form, confirming that informed consent has 
been gained and a recording saved on the secure electronic database developed by Derby CTSU to 
confirm this. 
 
On confirmation of informed consent, a mutually convenient time to undertake the telephone 
interview will be agreed. Interviews will be audio-recorded with consent from the participant. 
7.8.2. 
Qualitative Data Collection 
The interviews will be based on a semi-structured topic guide (POWER interview topic guide) 
developed in relation to the pre-specified aims (approximately 30-minute interview). It is expected 
that up to 25 patients will be sufficient to attain rich data. Interviews will be conducted, recorded 
and subject to targeted transcription by the CI. 
7.8.3. 
Qualitative Data Analysis  
Data will be analysed thematically as outlined by Braun and Clarke (17). Inductive analysis of 
transcripts will be undertaken to ensure that the context of an individual participant’s journey is 
preserved, while undertaking a broader thematic analysis to compare experiences across 
interviewees (17).  Analysis will compare and contrast data across different subgroups of patients 
(those receiving the physio intervention versus those on the waiting list, those having undergone 
surgery versus those still awaiting surgery, those believing that surgery is no longer required) to 
identify commonalities and contrasts.  Qualitative data findings will also be triangulated with 
findings from the SEAR data analysis (18) of numbers screened, eligible, approached and recruited to 
the study to explore reasons for initial participation, tensions around decisions to proceed to surgery 
if feeling better with the exercise programme, and concerns about the future if opting not to have 
surgery. Critical discussions amongst the research team and our PPI group, will then take place to 
verify, modify and refine the themes. 

 
 
 
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7.9. 
End of Study 
The end of study will be defined as when all data has been received and queries resolved. The 
Clinical Trials Manager will notify the Sponsor, participating sites and REC within 90 days of the end 
of study. The clinical study report will be written within 12 months of the end of study.  
 
 
 

 
 
 
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8. 
SAFETY REPORTING 
 
8.1. 
Definitions 
Term 
Definition 
Adverse Event (AE) 
Any untoward medical occurrence in a participant, including occurrences 
which are not necessarily caused by or related to study procedures. 
Related AE  
An untoward and unintended response in a participant to a study 
procedure. This means that a causal relationship between the study 
procedure and an AE is at least a reasonable possibility, i.e. the 
relationship cannot be ruled out. 
Serious Adverse 
Event (SAE) 
A serious adverse event is any untoward medical occurrence that: 
• results in death 
• is life-threatening 
• requires inpatient hospitalisation or prolongation of existing 
hospitalisation 
• results in persistent or significant disability/incapacity 
• consists of a congenital anomaly or birth defect 
Other ‘important medical events’ may also be considered serious if they 
jeopardise the participant or require an intervention to prevent one of 
the above consequences. 
NOTE: The term "life-threatening" in the definition of "serious" refers to 
an event in which the participant was at risk of death at the time of the 
event; it does not refer to an event which hypothetically might have 
caused death if it were more severe. 
Related SAE 
An adverse event that is both serious and, in the opinion of the reporting 
Investigator, believed with reasonable probability to be due to one of 
the study procedures. 
Related & 
Unexpected SAE  
A serious adverse event that; 
• 
is believed with reasonable probability to be due to one of the study 
procedures. 
• 
the nature and severity of which is not consistent with the 
information provided in the protocol i.e. it is not listed as an 
expected occurrence.  
 
8.2. 
Operational Definitions for (S)AEs 
 
For the purpose of this study, transient increases in shoulder pain associated with the programme of 
physiotherapist-led exercise are expected and will not be reported providing the participant is able 
to manage without the requirement for additional medication or consultation. Where participants 
report attendance at an appointment or consultation for pre-existing medical conditions or routine 
pre-operative or post-operative assessment or care, these will not be reported as adverse events. 
 
8.3. 
Recording and Reporting SAEs 
 
AEs and SAEs will be recorded from the time of randomisation until completion of the 6-month 
questionnaire or when the permitted time for completion of this questionnaire has ended.  
All (S)AEs occurring during the duration of the study will be self-reported by the participant or 
clinician (physiotherapist, surgeon, GP). All related and unexpected SAEs will be recorded by using 
the ‘non-CTIMP safety report to REC form’ from the HRA website. The completed form should be 
submitted to the Derby CTSU and REC within 15 days of the CI becoming aware of the event. Safety 
information will be reviewed during TMG and TSC meetings.  
 

 
 
 
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8.3.1. 
Assessment of AEs and SAEs 
 
8.3.1.1 
Severity 
Severity of the AE will be judged accordingly; 
• 
Mild: no interference with daily activities. 
• 
Moderate: moderate interference with daily activities. 
• 
Severe: considerable interference with daily activities (e.g. inability to work). 
NOTE: to avoid confusion or misunderstanding the term “severe” is used to describe the intensity of 
the event, which may be of relatively minor medical significance, and is NOT the same as “serious” 
which is described in the safety definitions.  
 
8.3.1.2 
Causality 
Clinical judgement should be used to determine the relationship between the study procedures and 
the occurrence of each AE;  
• 
Not related: There is no evidence of a causal relationship between the event and study 
procedures. 
• 
Related: There is evidence of a causal relationship between the event and study procedures 
i.e. a relationship to the study procedures cannot be completely ruled out. 
 
Assessment of causality will be made by the principal investigator, in consultation with the CI where 
required.  
 
8.3.1.3 
 
Expectedness 
The assessment of expectedness is only required if the event is deemed to be related to study 
procedures.  
• 
Expected: Event previously identified and described in the protocol. 
• 
Unexpected: Event not previously described in the protocol.  
The expectedness assessment will be made by the principal investigator, in consultation with the CI 
where required. 
 
8.4. 
Pregnancy reporting 
Pregnancy reporting is not required. 
 
8.5. 
Reporting Urgent Safety Measures 
If any urgent safety measure is taken the research team will inform the Derby CTSU within 24 
hours using the Derby CTSUs safety incident reporting form. The Derby CTSU will inform the 
REC and participating sites of the measures taken and the circumstances giving rise to those 
measures within 3 days on implementation of the urgent safety measure. 
 
9. 
DATA HANDLING 
 
The following section is a summary of data handling processes. A separate Data Management Plan 
(DMP) will be developed by the Derby CTSU and the CI and will include further detail on these 
processes. 
 
9.1 
System and compliance 
 
An electronic software platform will be used for trial data capture. Data capture will be via a web-
based, fully validated system, compliant with 21 CRF Part 11; Electronic records; Electronic 
signatures and EU Commission Directive 2005/28/EC with comprehensive audit trials. Derby CTSU 
will be responsible for database build and system validation. Data will be hosted externally according 
to General Data Protection Regulation guidance. 

 
 
 
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9.2 
Source Data 
 
Source data will consist of paper and electronic medical records depending on the data being 
collected. In some instances, the data is transcribed directly onto the eCRF and the eCRF will be 
considered source. The following table lists data collected in the study where the eCRF is not 
considered the source data: 
Data 
Source 
Informed Consent 
Paper consent form mailed to participant and 
audio recording 
Size & location of rotator cuff tear 
Medical records 
 
Participating sites will keep records of all participating patients and all original recordings of 
informed consent discussions. 
 
9.3 
Workflow 
 
The Derby CTSU Data Management team will maintain the EDC and the data will be hosted by the EDC 
supplier according to General Data Protection Regulation guidance. The trial database will be designed 
to capture the clinical data in accordance with the best principles of clinical data management and the 
relevant SOPs on Research Electronic System Specification, Selection, Validation and Implementation, 
Case Report Form and Database Selection, Development & Release and Data Security & Access Control 
developed by the Derby CTSU. 
 
Access to the trial database will be restricted by role-based permission to authorised trial personnel. 
Users will be suitably trained on the system prior to being granted access. Individual user accounts 
will be password protected and will not be shared between members of the trial team. 
 
Data will be entered into the eCRF by site staff and directly into the EDC system by participants for the 
purpose of collecting follow-up data. Post data entry, validation checks will be performed on the data 
to ensure accuracy and consistency according to the Data Validation Plan. All data queries generated 
as a result of these checks will be available for resolution by the site online. After data entry is 
complete, all data queries have been resolved, medical coding is complete and all forms have been 
signed by the PI, the database will be locked and released for statistical analysis. 
 
Derby CTSU will be responsible for study control (from design to study close-out), database build and 
system validation. All clinical data will be collected, stored, processed and archived in accordance with 
the Data Management Plan for this trial and in line with the relevant SOPs on Data Entry, Data Closeout 
Activities and Archiving developed by the Derby CTSU and any relevant legislation. 
 
9.4 
 Data Access and Security 
All documents will be stored safely in confidential conditions. With the exception of regulatory 
authorities, only staff as listed on the Delegation Log and the trial monitor will have access to source 
documents. The CI and study statistician will have access to the secure, password protected, study 
database for the purpose of reporting to the TMG and TSC and at the end of follow up for final data 
cleaning/checking and end-of-study analysis.  
 
On all clinical investigation-specific documents, other than the signed consent, the participant will be 
referred to by the clinical investigation participant number/code, not by name. Each participant will 
be assigned a study identity code number for use on study forms, other study documents and the 
electronic database. The investigator and trial team will ensure that the participant’s identity is 
protected at every stage of their participation within the trial, according to the Caldecott principles. If 

 
 
 
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any patient information needs to be sent to a third party the trial team will adhere to maintaining 
pseudo-anonymous participant parameters in correspondence. 
 
9.5 
Archiving 
At the end of the study, following completion of the end of study report, UHDB/ Derby CTSU will 
securely archive all centrally held study related documentation for a minimum of 10 years. At the 
end of the defined archive period arrangements for confidential destruction will be made. It is the 
responsibility of each PI to ensure that data and all essential documents relating to the study are 
retained securely for a minimum of 10 years after the end of study, and in accordance with national 
legislation. Derby CTSU will notify sites when study documentation held at sites may be archived, 
and then destroyed. All archived documents must continue to be available for inspection by 
appropriate authorities upon request.  
 
10. 
STATISTICS AND DATA ANALYSIS 
As this is a pilot RCT, the main analysis will focus on process outcomes, including consent rate, 
retention rate, and follow-up rates in line with the stated objectives. A detailed data analysis plan 
will be developed and reviewed by the TSC prior to any analysis being undertaken. 
 
At the end of the study, we will review the findings and in discussion with the TSC make a 
recommendation about proceeding to a future fully powered RCT. The following success criteria will 
be used to inform decision-making: 
 
Progression criteria
 
 
 
Red (Stop) 
Amber (Amend) 
Green (Go) 
Recruitment rate 1 
<20 
20 to <30 
30 or more 
Treatment fidelity 2 
<65 
65 to <80 
80 or more 
Follow-up 3 
<65 
65 to <80 
80 or more 
1. % of eligible patients 
2. % of participants randomised to physiotherapist-led exercise to have received initial assessment and exercise prescription within the 
study period 
3. % of SPADI questionnaires received at 6-months 
 
10.1. 
Sample Size Calculation 
To inform the development of a future, fully powered trial, and for the purpose of addressing the 
feasibility objectives, in keeping with recommendations for the sample size of an external pilot RCT, 
the target sample size is 76 (19). 
 
10.2. 
Planned Recruitment Rate 
Data from three sites that have expressed an interest in participating, suggest there are 
approximately 180 patients currently awaiting rotator cuff repair surgery at those sites. Assuming 
30% of patients approached are randomised, we will need to approach 254 patients in total to 
achieve the target sample size of 76. Hence, initially working with four sites, the study information 
pack will be provided to patients on the elective orthopaedic waiting list for surgical repair of the 
rotator cuff. In addition to this initial mailing, recruitment will be sequential over six-months and 
include patients who are subsequently added to the waiting-list. 
 
10.3. 
Statistical Analysis 
 
10.3.1. 
Summary of Baseline Data and Flow of Patients 
Descriptive statistics will be presented to summarize the distribution of baseline variables across 
each of the randomisation groups. Baseline variables, e.g. age, height, weight, will be reported using 
appropriate methods. 
 

 
 
 
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To meet objective one (estimate the numbers of eligible patients and rate of recruitment (Screened, 
Eligible, Approached, Randomised (SEAR)), a Consolidated Standards of Reporting Trials (CONSORT) 
flow diagram will be produced, showing the frequency of patients/ participants; 
• 
Number of patients screened for eligibility at each site and overall. 
• 
Number of patients found eligible as a proportion of those screened at each site and overall. 
• 
Number of patients approached (study information provided) as a proportion of those 
eligible at each site and overall. 
• 
Number of patients who consent to participate as a proportion of those approached at each 
site and overall. 
• 
Number of participants randomised, include number allocated to each group 
 
To meet objective two (describe the reasons for not wanting to participate based on SEAR data), the 
CONSORT diagram will include: 
• 
Number of patients found eligible who were subsequently not approached and the reasons 
for this (e.g. surgery scheduled imminently, no time to approach, no contact details) 
• 
Number of patients approached who subsequently did not want to participate and the 
reasons for this (e.g. surgery scheduled imminently, previous non-response to 
physiotherapy, not interested, not enough time, shoulder problem resolved). 
 
To meet objective three (report treatment fidelity with regards to the number of physiotherapy 
appointments attended and self-report exercise adherence (intervention group only), the number 
and proportion of patients randomised to the programme of physiotherapist-led exercise who 
participated in one or more treatment sessions will be reported, as well as the mean number of 
treatment sessions attended and SD.  Where participants in the intervention group received one or 
more treatment sessions, this will be reported via the CONSORT flow diagram as receiving the 
allocated intervention. 
 
For the purpose of understanding self-report exercise adherence, participants will be asked to 
respond to the question; to what extent do you agree with the following statement? 'I have been 
doing my exercises as often as prescribed.' (strongly agree/ agree/ not sure/ disagree/ strongly 
disagree) and the number of responses in each category will be reported as a proportion of all 
responses at each follow-up time point. 
 
To meet objective four (report the completion rate of outcome measures), the number and 
proportion of SPADI and EQ-5D-5L questionnaires completed at each follow-up time point, including 
via minimal data collection, will be reported. 
 
To meet objective five (describe the number and nature of adverse events six-months following 
randomisation), the number and nature of adverse events which occur will be reported overall and 
by study arm. 
 
10.3.2. 
Outcome Analysis 
Between-group analysis of total SPADI score will be undertaken using ANCOVA for the purpose of 
generating associated confidence intervals to evaluate any signal of effectiveness of the 
intervention, to inform planning of a future trial (20). Analysis will be according to the Intention-to-
Treat (ITT) principle and include any randomised participant, regardless of whether they received the 
study intervention. A secondary per protocol analysis will be conducted based on minimum fidelity 
criteria (one or more treatment sessions attended).  
 
10.4. 
Subgroup Analyses 
Not applicable. 
 

 
 
 
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10.5. 
Adjusted analyses 
Not applicable. 
 
10.6. 
Interim Analysis and Criteria for the Premature Termination of the Study 
 
No pre-specified interim analyses are planned.  
 
The Derby CTSU and/or Sponsor may suspend or prematurely terminate either the entire study, or 
the study at an individual site, for significant reasons that must be documented (e.g. an 
unacceptable risk to participants or serious repeated deviations from the protocol/ regulations). If 
this occurs the Derby CTSU/ Sponsor shall justify its decision in writing and will promptly inform any 
relevant parties (i.e. participants, investigators, participating sites, REC, regulatory bodies).  
 
10.7. 
Analysis Groups 
For the purpose of generating confidence intervals to facilitate evaluation of any signal of 
effectiveness, primary analysis will be according to the Intention To Treat (ITT) principle and include 
any randomised participant, regardless of whether they received the study intervention. 
 
10.8. 
Procedure(s) to Account for Missing or Spurious Data 
As this is a pilot RCT, no methods to account for missing data will be used but will be reported 
accordingly.  
 
11. 
MONITORING, AUDIT & INSPECTION 
Source documents and other documentation for this study will be made available to study monitors, 
the REC or regulatory authority inspectors. Authorised representatives of the Derby CTSU/ Sponsor 
may visit the participating sites to conduct audits/ inspections.  
 
12. 
ETHICAL AND REGULATORY CONSIDERATIONS 
 
12.1. 
Assessment and Management of Risk 
For patients who would be recruited to this study, standard care is to remain on the waiting list for 
surgery. However, a programme of physiotherapist-led exercise is usually prescribed for patients 
with rotator cuff tears prior to consideration of surgery. Thus, physiotherapist-led exercise usually 
features in the standard treatment pathway, meaning that the risk compared to standard care is 
similar. The intervention, physiotherapist-led exercise, will be delivered by qualified physiotherapists 
who are trained in the specific exercise programme and who prescribe exercise as part of their usual 
clinical practice. 
 
12.2. 
Peer review 
This study has been peer reviewed as part of the NIHR application to re-purpose this funding. 
Further review has been undertaken by members of the TSC. 
 
12.3. 
Public and Patient Involvement 
One patient, currently awaiting surgery to repair the rotator cuff, has been consulted about this 
research. The patient was very supportive of the idea given that his own experience has been to 
improve while waiting for surgery and has now opted to further delay surgery given this 
improvement. The patient will continue to advise regarding study design and contribute to trial 
management as part of the TMG. 
 
Further, the current TSC includes two patient members who have reviewed and are supportive of 
this study and will provide continued oversight for the duration of the study. 
 

 
 
 
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While developing the physiotherapist-led exercise programme, and associated materials including 
patient information sheets, patients were included in the development process and review of 
patient-facing material.  
 
12.4. 
Research Ethics Committee (REC) & Regulatory Considerations 
 
The study will be conducted in compliance with the approved protocol and the Declaration of 
Helsinki. The protocol and all related documentation (e.g. informed consent form, participant 
information sheet, questionnaires) have been reviewed and received approval by a Research Ethics 
Committee (REC). The investigator will not begin any participant activities until approval from the 
HRA and REC has been obtained and documented. All documentation and correspondence will be 
retained in the trial master file/investigator site file. Substantial amendments that require HRA and 
REC (where applicable) review will not be implemented until the HRA and REC grants a favourable 
opinion (with the exception of those necessary to reduce immediate risk to participants).  
 
It is the responsibility of the Derby CTSU to ensure that an annual progress report (APR) is submitted 
to the REC within 30 days of the anniversary date on which the favourable opinion was given, 
annually until the study is declared ended. The Derby CTSU is also responsible for notifying the REC 
of the end of study (see Section 6.9) within 90 days. Within one year of the end of study, the 
Sponsor will submit a final report with the results, including any publications/abstracts to the REC. 
 
Before any site can enroll a patient into the study confirmation of capacity must be sought from the 
site’s research and development (R&D) department. In addition for any amendment that will 
potentially affect the site’s permission, the research team must confirm with the site’s R&D 
department that permission is ongoing (Section 11.10). 
 
12.5. 
Protocol Compliance/ Non-Compliance  
The CI is responsible for ensuring that the study is conducted in accordance with the procedures 
described in this protocol. Prospective, planned deviations and/or waivers to the protocol are not 
acceptable, however accidental protocol deviations (non-compliances) may happen and as such 
these will be recorded. Non-compliances will be recorded in the CRF and/or a non-compliance log 
kept in the ISF.  All non-compliances will be reviewed and assessed by the PI (or appropriately 
delegated individual) to determine if they meet the criteria of a “serious breach” (Section 12.6). 
Non-compliances which are found to frequently recur are not acceptable, will require immediate 
action, and could potentially be classified as a serious breach. 
 
12.6. 
Notification of Serious Breaches to GCP and/or the Protocol 
A “serious breach” is a departure from the protocol, Sponsor procedures (i.e. SOPs), or regulatory 
requirements which is likely to effect to a significant degree – 
(a) The safety or physical or mental integrity of the subjects of the study; or 
(b) The scientific value of the study. 
If the PI (or delegate) is unsure if a non-compliance meets these criteria, they should consult the 
Sponsor for further guidance.  
 
If a serious breach is identified the investigator should notify the Derby CTSU immediately (i.e. within 
1 working day) using the ‘Non-CTIMP Notification of a Serious Breach’ form. The report will be 
reviewed by the Derby CTSU and CI, and where appropriate, the Derby CTSU will notify the REC 
within 7 calendar days of being made aware of the breach.  
 
12.7. 
Data Protection and Patient Confidentiality 
The study will be conducted in accordance with the Data Protection Act 2018. We will ensure that 
participant’s anonymity is maintained throughout the study and following completion of the study. 

 
 
 
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Participants will be identified on all study specific documents (except for the informed consent form 
and enrolment log) only by the participants study specific identifier (and initials if deemed necessary). 
This identifier will be recorded on documents, and the database. For the purpose of the electronic 
questionnaires, their IP address will also be stored in the database for functional reasons but will not 
be needed for analysis and therefore will never be extracted. The investigator site file will hold an 
enrolment log detailing the study specific identifier alongside the names of all participants enrolled in 
the study. All documents will be stored securely with access restricted to study staff and authorised 
personnel.  
 
Verbal consent and subsequent qualitative interviews will be recorded by the CI and saved securely 
on the electronic database developed by Derby CTSU. Only the CI and invited members of the research 
team will have access to the saved recordings. On completion of the qualitative interviews, the CI will 
upload the recording and then immediately delete the recording from the audio recorder. Audio-
recordings will be labelled with the participant identification number; identifiable patient details will 
not be used.  
 
Audio-recordings will be subject to targeted transcription by the CI and edited to protect the 
anonymity of respondent. At the end of the study, audio-recordings will be kept for at least 10 years 
before they will be destroyed. 
 
The CI will act as the custodian of the data generated in the study. 
 
12.8. 
Financial and Other Competing Interests for the Chief Investigator, Principal 
Investigators at Each Site and Committee Members for the Overall Study 
Management 
There are no conflicts of interest. 
 
12.9. 
Indemnity 
This study is sponsored by University Hospitals Derby and Burton NHS Foundation Trust who provide 
indemnity against negligent and non-negligent harm caused by the design and/or management of 
the study. For harm to participants arising from the conduct of the research indemnity is provided 
through the NHS schemes or professional indemnity of NHS staff. 
 
12.10. 
Amendments 
If changes to the study are required these will be discussed with the Sponsor, who is responsible for 
deciding if an amendment is required and if it should be deemed substantial or non-substantial. 
Substantial amendments will be submitted to the relevant regulatory bodies (REC, HRA) for review 
and approval. The amendments will only be implemented after approval and a favourable opinion 
has been obtained. Non-substantial amendments will be submitted to the HRA for their approval/ 
acknowledgment. Amendments will not be implemented until all relevant approvals are in place. 
 
12.11. 
Access to Final Study Dataset 
Request for the anonymised datasets generated during and/or analysed during the current study can 
be made by contacting the CI in the first instance. Only de-identified data are available for request in 
aggregated format or at the level of the individual participant. 
 
13. 
DISSEMINATION POLICY 
 
13.1. 
Dissemination Policy 
The primary aim of this study is to establish the feasibility of conducting a future fully powered 
randomised controlled trial and hence dissemination plans, outputs and anticipated impact need to 
be considered in this context. The results report will be published in an open-access peer reviewed 

 
 
 
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publication with the highest possible impact factor. The findings will also be disseminated to patient 
and clinician groups and at relevant conferences, particularly the British Elbow & Shoulder Society 
Conference, as well as other outlets including social media and blog posts.  
 
14. 
REFERENCES 
1.  
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cost-effectiveness of open and arthroscopic rotator cuff repair [the UK rotator cuff surgery 
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Ensor K, Kwon Y, DiBeneditto R, Zuckerman J, Rokito A. The rising incidence of rotator cuff 
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Paloneva J, Lepola V, Äärimaa V, Joukainen A, Ylinen J, Mattila VM. Increasing incidence of 
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Longo UG, Salvatore G, Rizzello G, Berton A, Ciuffreda M, Candela V, et al. The burden of 
rotator cuff surgery in Italy: a nationwide registry study. Arch Orthop Trauma Surg. 
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6.  
HES. Hospital Episode Statistics, Hospital Admitted Patient Care Activity 2018-19 [Internet]. 
2019 [cited 2020 May 18]. Available from: https://digital.nhs.uk/data-and-
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7.  
NHS Improvement. 2019/20 National Tariff Workbook [Internet]. National tariff payment 
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Kuhn JE, Dunn WR, An Q, Baumgarten KM, Bishop JY, Brophy RH, et al. Effectiveness of 
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Holmgren T, Bjornsson H, Oberg B, Adolfsson L, Johansson K. Effect of specific exercise 
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Malliaras P, Cridland K, Hopmans R, Ashton S, Littlewood C, Page R, et al. Internet and 
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Russell TG, Buttrum P, Wootton R, Jull GA. Internet-based outpatient telerehabilitation for 
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Littlewood C, Astbury C, Bush H, Gibson J, Lalande S, Miller C, et al. Development of a 
physiotherapist-led exercise programme for traumatic tears of the rotator cuff for the SPeEDy 
study. Physiotherapy [Internet]. 2020; Available from: 
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Hopewell S, Keene DJ, Maia Schlüssel M, Dritsaki M, Dutton S, Carr A, et al. Clinical and cost-
effectiveness of progressive exercise compared with best practice advice, with or without 
corticosteroid injection, for the treatment of rotator cuff disorders: Protocol for a 2x2 
factorial randomised controlled trial (the GRASP trial). BMJ Open. 2017;7(7).  
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Littlewood C, Malliaras P, Mawson S, May S, Walters S. Development of a self-managed 
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Roach K, Budiman-Mak E, Songsiridej N, Lertratanakul Y. Development of a Shoulder Pain and 

 
 
 
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Disability Index. Arthritis Care Res. 1991;4(4):143–9.  
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van Reenen M, Janssen B. EQ-5D-5L User Guide Basic information on how to use the EQ-5D-
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15. 
APPENDICES 
 
 
15.1. 
Appendix 1 – The physiotherapist-led exercise programme 
 
During the first meeting, the physiotherapist will ask the participant about treatment related goals 
linked to functional activities. For example, participants might have difficulty reaching to a shelf at 
home, lifting at work, or sports-related difficulties, including serving at tennis etc.  Once these have 
been identified, the physiotherapist will break down the identified functional activities into 
component parts. For example, if the participant complains of difficulty reaching to a shelf, 
predominantly an activity of forward-flexion of the shoulder, initial assessment of exercise capacity 
will commence in relation to forward-flexion of the shoulder. 
To highlight this, the assessment commences with testing of active-assisted forward flexion starting 
with the arm by the side and moving to 30⁰ (Figure 1). Given the lack of research evidence 
supporting an optimal number of repetitions and sets and considerable variation in clinical practice 
(21,22), a self-dosed approach will be taken where the participant is advised that the exercise should 
always be challenging to them. The participant could be challenged in relation to pain response, 
fatigue or perceived exertion, or a combination but this challenge should always be at a level that is 
acceptable to the individual participant. The level of acceptable response is likely to vary between 
participants but they will be re-assured that such challenge does not equate to damage and they 
should be guided by what is acceptable to them rather than with reference to generic guidance that 
might not be acceptable to them and hence would serve as a barrier to exercise adherence. So, for 
example, a participant might commence repeated active-assisted forward flexion with the arm by 
the side and moving to 30⁰. The first 20 repetitions might be perceived as challenging but 
acceptable, but repetitions beyond this become unacceptable. Then, the participant records the 
type of exercise performed and the number of sets and repetitions in the POWER exercise booklet. 
This record sets the target for the participant to meet and exceed during their next exercise session. 
Such an approach facilitates progressive exercise. Participants will be advised to aim for a minimum 
of one exercise session per day, a minimum of five days per week, and up to three different exercise 
series will be prescribed, e.g. forward-flexion, abduction (reaching out to the side away from the 
body), and reaching behind back. Given the self-dosed nature of this programme, no upper limit will 
be prescribed providing the response remains within an individually acceptable limit. For example, 
participants would be asked to re-consider their approach to self-dosing if it was felt the number of 
exercises undertaken was contributing to pain that impaired sleep. 
 
Figure 1 Active-assisted forward flexion starting 
with the arm by the side and moving to 30⁰ 
Figure 2 Active-assisted forward-flexion of the 
shoulder with the aim of reaching 90⁰ 
 
If stage one exercises are perceived as not challenging, the participant will be able to move on to 
stage two exercises. Multiple exercise prescriptions and progressions are detailed in relation to 
various functional difficulties. These prescriptions and progressions are detailed in POWER exercise 

 
 
 
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booklet with photographs and descriptive text in sufficient detail to enable replication, informed by 
the TIDieR checklist (23). In this example, stage two exercise would be active-assisted forward-
flexion of the shoulder with the aim of reaching 90⁰ (Figure 2). Following the same principles of 
progression, stage three would incorporate active-assisted flexion to 180⁰. Although we expect that 
many participants will have exercise capacity greater than these initial stages, this assessment 
process is important in the context of exercise prescription because it teaches the participants how 
to progress but also regress their own exercise. This means that if the response to exercise becomes 
unacceptable when exercising away from the physiotherapist, the participant has the understanding 
of how to regress the exercise to maintain acceptable levels. Similarly, the patient also has 
understanding of how to progress the exercise, as they feel able. Such progression is an important 
component of effective exercise prescription (21) 
Stages four, five and six, would include progression to active exercise; up to 30⁰ for stage four, up to 
90⁰ for stage five (Figure 3), and then up to 180⁰ for stage six (Figure 4). 
 
Figure 3 Active forward-flexion of the arm 
reaching to 90⁰ 
Figure 4 Active forward-flexion of the arm 
reaching to 180⁰ 
 
Stages seven, eight and nine, would include progression to resisted exercise; up to 30⁰ for stage 
seven, up to 90⁰ for stage eight (Figure 5), and then up to 180⁰ for stage nine (Figure 6). 
 
Figure 5 Resisted forward-flexion of the arm 
reaching to 90⁰ 
Figure 6 Resisted forward-flexion of the arm 
reaching to 180⁰ 
 
The final stage of the physiotherapist-led exercise programme will include functional restoration 
with exercise prescribed by the physiotherapist in relation to the specific functional difficulty rather 
than isolated movements. In this example, the participant would be encouraged to undertake 
repeated reaching to the shelf, initially with assistance, then without and then against resistance 
provided through an elastic training band or hand-weight. 
 
 

 
 
 
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15.2. 
Appendix 1 - Amendment History 
 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
 
 
 
 
 
 
Detail all protocol amendments. Protocol amendments must be submitted to the Derby CTSU & 
Sponsor for approval prior to submission to the REC.