Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001768886
Ethics application status
Approved
Date submitted
15/11/2021
Date registered
23/12/2021
Date last updated
29/11/2022
Date data sharing statement initially provided
23/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Shoulder HD Pilot Trial: a comparison of exercise interventions for rotator cuff tendinopathy
Scientific title
The Shoulder HD Pilot Trial: The feasibility, safety and efficacy of high load-volume exercise versus low load-volume exercise for rotator cuff tendinopathy
Secondary ID [1] 305765 0
None
Universal Trial Number (UTN)
U1111-1271-4120
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff tendinopathy 324267 0
Shoulder pain 324268 0
Rotator cuff tendinitis 324269 0
Rotator cuff related shoulder pain 324270 0
Sub-acromial shoulder pain 324271 0
Shoulder bursitis 324272 0
Condition category
Condition code
Musculoskeletal 321762 321762 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 321763 321763 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A 12 week exercise program will be delivered by a registered physiotherapist who has completed training in prescribing exercise for rotator cuff tendinopathy. Participants will attend 7 sessions with their physiotherapist, a minimum of 3 sessions will be face to face. Participants have the option to complete the remaining 4 sessions as face to face appointments or via telehealth if they prefer. Participants will be randomised into two different exercise programs.
Both groups will complete the same 3 shoulder exercises (shoulder press, lateral shoulder raise, bent over row). One group will complete high load-volume exercise and the other group will complete low load-volume exercise (see next section). Based on evidence from previous trials, including 2 large randomised trials published in 2021 (GRASP and SEXSI trials), it is unclear if one exercise program is superior to the other.

Arm 1 - High load-volume: This group will complete three shoulder strengthening exercises (1. Shoulder press, 2. Lateral shoulder raise, 3. Bent over row) with progression over time, three times per week over 12 weeks. In total participants will complete 36 sessions with 7 of these sessions being supervised by their treating physiotherapist as above. The rest of the sessions will be completed by the patient independently at home. Exercise sessions are expected to take approximately 20-30 minutes at most. The intensity (load) will be progressed over time in order to target the desired level of work based on an auto-regulatory approach (repetitions in reserve). The target repetitions in reserve starts at 3-5 and progresses to 1-2 by the final weeks. Participants will use dumbbell weights as resistance in order to meet the intended intensity, reps in reserve target. The number of sets and repetitions begins at 3 sets of 8 and progresses to 5 sets of 4 by week 12. The total volume (sets x reps) is 858 over the 12 weeks. Participants will be advised to take 2-3 minutes rest between sets. The treating physiotherapist will progress and regress the exercises in accordance with the patients level of pain, discomfort and level of fatigue. Participants and when supervised the treating physiotherapist will progress or regress the intensity (load) in order to achieve the target repetition in reserve for that session.


Information relevant to both the intervention and control groups
Education
Participants in both groups will receive education material based upon current evidence and guidelines in order to help them understand their shoulder pain and how to best manage it. This education material has been developed for this trial and has been updated from education materials previously used by our research group. The material will be available electronically and if preferred a printed version will be supplied.
Education material will be delivered via their treating physiotherapist and outlines the shoulder joint anatomy, the usual presenting symptoms of rotator cuff tendinopathy, the causes and contributing factors, how rotator cuff tendinopathy is diagnosed, whether a scan is necessary, the recommended guideline based treatments, the potential benefits and harms for treatments including surgery and exercise, guidelines for pain and exercise and how long it usually takes for rotator cuff tendinopathy to improve.

Intervention fidelity will be checked for each treating practitioner (minimum of one session) via audio or video recording.
Participants progress will be monitored via fortnightly pain questionnaire throughout the duration of the 12 week program and using functional questionnaires at 6, 12 and 26 weeks from the commencement of the intervention. Participants will also complete measurements for strength at baseline pre intervention commencement and again at 6, 12 and 26 weeks post intervention commencement.

Exercise adherence: Participants will record their completed exercise via an online form / exercise diary. Participants will be asked to wear an IMU activity tracking sensor on the wrist of their affected shoulder for as much of the 12 week intervention program as able. Data collected from this sensor will be analysed to determine velocity of movement, number of sets and repetitions for each exercise and general physical activity / sleep.

Details of the exercise program for both groups:
1. Administered by a registered physiotherapist who has completed training in exercise for rotator cuff tendinopathy
2. Exercise will be delivered via face to face sessions, with the option of several telehealth sessions if preferred (total 7 sessions with a minimum of 3 face to face). Education material will be provided in written format (paper or electronic) and will be reviewed by the treating physiotherapist during the treatment sessions.
3. Participants will attend 7 supervised physiotherapy sessions over 12 weeks. They will complete the remaining sessions at home independently.
4. Both groups will be advised to continue with their exercise program throughout the 12 week intervention if they have pain which they consider acceptable, manageable or bearable. They will be advised that some pain post exercise is considered normal, provided that it has returned to their normal baseline level within 24 hours. If participants experience progressing or worsening pain that become unbearable (>5/10) during their exercises they will be advised to reduce the range of movement, reduce the load or intensity if applicable or to modify the exercises.

All materials will be provided to the participants via electronic written form unless they prefer a paper / print version which will be made available if required. Participants will record the number of completed sets and repetitions in an online exercise diary web form, which will also be made available in a paper version if a participant prefers.

Physiotherapists delivering the treatment will not deliver the exercise program to both groups. They will be restricted in delivering the exercise program to either the intervention group or the control group but not both.
Intervention code [1] 322166 0
Treatment: Other
Intervention code [2] 322334 0
Rehabilitation
Comparator / control treatment
Arm 2 - Low load-volume: This group will complete the same 3 shoulder exercises (1. Shoulder press, 2. Lateral shoulder raise, 3. Bent over row). These exercises will be prescribed without any added resistance or weights (load). Participants will work against gravity only. Over the course of the 12 week program the volume (sets x reps) will be equivalent between the high load-volume group and the low load-volume group. Participants will start with 2 sets of 5 and progress to 3 sets of 20 by the 12th week. Total volume for the low load-volume group is 862 repetitions (within 4 repetitions of the high load-volume group, 858).

Participants in the low load-volume group will complete 4 sessions per week over the first 4 weeks, 3 sessions per week over the second 4 weeks and 2 sessions per week for the final 4 weeks of the 12 week intervention. In total the low load-volume group will complete 36 exercise sessions (the same as the high load-volume group). Of these 36 sessions, 7 sessions will be supervised during their scheduled physiotherapy appointments, the remaining sessions will be completed independently at home. This is the same number of supervised sessions as the intervention group.

Exercise sessions are expected to take approximately 20 minutes to complete. It is anticipated that the low load-volume group may complete their exercise sessions slightly faster than the high load-volume group as they are not likely to require as long a rest period between each exercise.

The primary difference between the high load-volume group and the low load-volume group will be the load intensity.

Both groups will receive the same educational material as described above.

Control group
Dose comparison

Outcomes
Primary outcome [1] 329512 0
This is a pilot and feasibility study, therefore the primary outcomes will be study processes and feasibility. All study data will be collected electronically via a REDCap study database. Paper versions will be provided if participants prefer and subsequently entered into the REDcap database.

1. Number of eligible participants and rate of recruitment will be reported. Rate of conversion will be calculated as the number of participants enrolled divided by the number of eligible participants. The number of enquiries and number of potentially eligible participants will be reported for the duration of the recruitment.
Timepoint [1] 329512 0
Recruitment rate will be reported for the total duration of the trial.
For example, the trial recruitment occurred over xx number of days with xx potentially eligible participants and xx confirmed participants enrolled in the study. Trial recruitment will be assessed at the conclusion of the trial.
Primary outcome [2] 329513 0
2. Adherence
Exercise program adherence will be recorded for each completed exercise session via online web form (REDCap database) or via a paper system if patients are unable to use the online form.
Adherence will be calculated as the percentage of prescribed sessions completed.
Timepoint [2] 329513 0
Completed exercise sessions will be recorded weekly at the time of each exercise session.
The primary timepoint for this outcome is 12 weeks post intervention commencement (i.e. completion of the 12 week exercise program)
Primary outcome [3] 329514 0
3. Adverse events
Adverse events will be defined by any unfavourable or unintended sign, symptom or diagnosis associated with the study which may or may not be related to the intervention (e.g. fall, injury or change in medical status). Adverse events will be recorded and categorised according to the following criteria:
• Rotator cuff tendinopathy adverse event: It is anticipated that participants experience a level of discomfort or soreness as part of the routine healing process in response to exercise. Participants will be provided advice regarding an acceptable level of symptoms. An adverse event will only be recorded if it results in seeking additional care (i.e. a consultation, or taking more medication than usual).
• A serious adverse event is defined as an event related or not to the intervention that results in death, life threatening complication, hospitalisation, surgery, permanent or temporary physical disability, congenital abnormalities, or any findings the CI and/or research team feel can lead to significant health hazards. Examples of serious events include but are not limited to surgery for tendon rupture or heart attack requiring hospitalisation.
Adverse events will be recorded by a yes / no response followed by an open-response questionnaire.
Timepoint [3] 329514 0
Adverse events will be recorded via patient questionnaire emailed to participants fortnightly from the time of intervention commencement to 2 weeks post completion of the intervention (i.e. adverse event questionnaire emailed at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks and 14 weeks post intervention commencement).
Adverse events will be categorised as mild, moderate, severe or serious in line with the Common Terminology Criteria for Adverse Events (CTCAE5.0)
Secondary outcome [1] 402823 0
Shoulder pain and function measured by the Shoulder Pain and Disability Index (SPADI)
Timepoint [1] 402823 0
0, 6, 12 and 26 weeks post intervention commencement
Secondary outcome [2] 402824 0
Overall pain intensity measured by a 100mm visual analogue scale
Timepoint [2] 402824 0
Fortnightly questionnaire
0, 2, 4, 6, 8, 10, 12 and 14 weeks post intervention commencement
Secondary outcome [3] 402825 0
Global rating of change measured using the Patient Global Impression of Change (PGIC) 7-point likert scale
Timepoint [3] 402825 0
0, 6, 12, 26 weeks post intervention commencement
Secondary outcome [4] 402826 0
Health related quality of life measured using the EuroQol 5D-5L
Timepoint [4] 402826 0
0, 6, 12, 26 weeks post intervention commencement
Secondary outcome [5] 402827 0
Physical activity levels measured using the International Physical Activity Questionnaire - short form
Timepoint [5] 402827 0
0, 6, 12, 26 weeks post intervention commencement
Secondary outcome [6] 402828 0
Sleep disturbance measured using the Insomnia Severity Index
Timepoint [6] 402828 0
0, 6, 12, and 26 weeks post intervention commencement
Secondary outcome [7] 402829 0
Fear of movement measured using the Tampa scale for kinesiophobia
Timepoint [7] 402829 0
0, 6, 12 and 26 weeks post intervention commencement
Secondary outcome [8] 402830 0
Shoulder strength and load/velocity strength profile
Measured via one repetition maximum (1RM) shoulder strength test and force velocity profiling for each shoulder exercise.

This is a composite measure. That is the force velocity profile is a graph plotted from the testing procedure for the 1RM shoulder strength tests.
Timepoint [8] 402830 0
0, 6, 12 and 26 weeks post intervention commencement
Secondary outcome [9] 402831 0
OMNI scale for perceived exertion
Timepoint [9] 402831 0
Measured at the end of each completed exercise set
Secondary outcome [10] 402832 0
Therapeutic alliance measured using the Working Alliance Inventory short revised form
Timepoint [10] 402832 0
12 weeks post intervention commencement
Secondary outcome [11] 402833 0
The use of health services and co-interventions will be measured using a patient questionnaire.
Timepoint [11] 402833 0
Use of health services and co-interventions will be recorded via patient questionnaire emailed to participants fortnightly from the time of intervention commencement to 2 weeks post completion of the intervention (i.e. questionnaire emailed at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks and 14 weeks post intervention commencement).
Secondary outcome [12] 403682 0
Work productivity and activity impairment questionnaire (v2.0)
Timepoint [12] 403682 0
0, 6, 12 and 26 weeks post intervention commencement
Secondary outcome [13] 403683 0
This is a primary outcome

Rate of retention. Reported as the percentage of participants who completed the exercise program. This will be calculated from data collected in the REDCap study database.
Timepoint [13] 403683 0
Reported at 6 and 12 weeks post intervention commencement
Secondary outcome [14] 403684 0
This is a primary outcome

Response rate to questionnaires. Reported as a percentage of completed questionnaires out of the total number of sent questionnaires. Collected via REDCap study database.
Timepoint [14] 403684 0
Reported at 6, 12 and 26 weeks post intervention commencement
This will also consider the response rate and completion of the fortnightly questionnaires (weeks 2, 4, 6, 8, 10, 12 and 14 post intervention commencement) and the completion rate of the weekly exercise diary.
Secondary outcome [15] 404392 0
Participant acceptability of interventions, barriers and enablers to adherence will be explored via qualitative interviews. Interviews will be conducted via zoom video meeting and audio recorded. Or where possible a face to face meeting with audio recording.
Timepoint [15] 404392 0
Interviews will be conducted within 2-4 weeks of completing the 12 week intervention.
Secondary outcome [16] 404393 0
Care provider acceptability of interventions, barriers and enablers to adherence will be explored via qualitative interviews. Interviews will be conducted via zoom video meeting and audio recorded. Or where possible a face to face meeting with audio recording.
Timepoint [16] 404393 0
Interviews will be conducted within 2-4 weeks of completing the 12 week intervention.

Eligibility
Key inclusion criteria
Inclusion criteria
• Primary complaint of shoulder pain on one or both sides
• Aged 18 years or older
• Shoulder pain for >6 weeks
• Worst shoulder pain over the last week >3/10 on a 0-10 point numerical rating scale
• Clinical diagnosis of rotator cuff tendinopathy based on established criteria including anterolateral shoulder pain AND pain with active or resisted shoulder abduction
• Absence of other non-traumatic musculoskeletal conditions affecting the shoulder based on established criteria (i.e. severe osteoarthritis, pain referred from the neck, instability, frozen shoulder)
• Not currently completing a prescribed exercise program for their shoulder pain over the past 6 weeks
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they satisfy any of these criteria:
• History of significant trauma (e.g. a fall) that resulted in onset of current shoulder pain
• History of shoulder fracture or traumatic dislocation
• A neurological disease affecting the shoulder (e.g. Parkinson’s Disease)
• Systemic pathology including inflammatory joint disease and neoplastic disorders
• Symptoms of complex regional pain syndrome
• Received an injection (corticosteroid, hydrodilatation or platelet rich plasma injection for their current shoulder pain within the last three months
• Previous shoulder surgery
• Evidence of severe osteoarthritis (OA) on shoulder radiograph

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research staff who are not involved in outcome assessment will randomise participants off-site and inform the allocated physiotherapist. Outcome assessors, trial statisticians and researchers entering data will be blind to treatment allocation. Participants will know they are receiving an exercise intervention, but we will make it clear that we do not know which will be more effective, and will not disclose details of the interventions or our hypothesis in verbal and written materials. Further, participants will not be treated concurrently and participants will be asked not to discuss their treatment group with outcome assessors.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation sequence (permuted blocks of variable size, stratified by trial site) will be created and imported into the REDCap randomisation tool by an independent administrator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a feasibility trial, the main analysis will focus on process outcomes. This will include the number of potentially eligible participants, recruitment and retention rates, response rates to questionnaires and exercise adherence (% of prescribed sessions completed). The following success criteria will be used to decide trial modification/whether to proceed to full trial: (i) Recruitment rates: Consent and randomisation of 20% or more of eligible patients. (ii) Intervention adherence: 80% or more of the number of sessions completed in each group; (iii) follow-up rates of internet questionnaire outcomes of 80% or more. This feasibility trial will not be powered to identify treatments effects related to pain and function, however, baseline and follow-up between group differences will be investigated to determine potential trends in the outcomes of interest and guide design of a full-scale trial.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/01/2022
Actual
21/01/2022
Date of last participant enrolment
Anticipated
18/02/2022
Actual
18/03/2022
Date of last data collection
Anticipated
7/12/2022
Actual
Sample size
Target
32
Accrual to date
Final
31
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 35921 0
3280 - Warrnambool
Recruitment postcode(s) [2] 35922 0
3550 - Bendigo
Recruitment postcode(s) [3] 35923 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 310123 0
Charities/Societies/Foundations
Name [1] 310123 0
Arthritis Australia
Country [1] 310123 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 311190 0
None
Name [1] 311190 0
Address [1] 311190 0
Country [1] 311190 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309811 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 309811 0
Ethics committee country [1] 309811 0
Australia
Date submitted for ethics approval [1] 309811 0
03/09/2021
Approval date [1] 309811 0
06/09/2021
Ethics approval number [1] 309811 0
30397

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 115470 0
A/Prof Peter Malliaras
Address 115470 0
Department of Physiotherapy
School of Primary and Allied Health Care
Building B
Monash University
Peninsula Campus
Frankston, Victoria, 3199
Country 115470 0
Australia
Phone 115470 0
+61 400206480
Fax 115470 0
Email 115470 0
[email protected]
Contact person for public queries
Name 115471 0
Josh Naunton
Address 115471 0
Department of Physiotherapy
School of Primary and Allied Health Care
Building B
Monash University
Peninsula Campus
Frankston, Victoria, 3199
Country 115471 0
Australia
Phone 115471 0
+61 407530123
Fax 115471 0
Email 115471 0
[email protected]
Contact person for scientific queries
Name 115472 0
Josh Naunton
Address 115472 0
Department of Physiotherapy
School of Primary and Allied Health Care
Building B
Monash University
Peninsula Campus
Frankston, Victoria, 3199
Country 115472 0
Australia
Phone 115472 0
+61 407530123
Fax 115472 0
Email 115472 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified outcome data - all of the individual participant data collected during the trial
When will data be available (start and end dates)?
Upon request at any time. Data will be made available from September 2022
No end date is determined
Available to whom?
Researchers
Available for what types of analyses?
Meta-analysis
Reproducing study results
How or where can data be obtained?
From the lead researcher(s)
Data will be made available by emailing Peter Malliaras or Josh Naunton
[email protected]
[email protected]

Data may be uploaded to a data repository


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.