Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000308594
Ethics application status
Approved
Date submitted
5/02/2024
Date registered
22/03/2024
Date last updated
28/07/2024
Date data sharing statement initially provided
22/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel evidence-based group exercise and education intervention for rotator cuff related shoulder pain: a pilot randomised controlled trial
Scientific title
A novel evidence-based group exercise and education intervention for adults with rotator cuff related shoulder pain: a pilot randomised controlled trial
Secondary ID [1] 309924 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff related shoulder pain 330492 0
Condition category
Condition code
Musculoskeletal 327340 327340 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 329819 329819 0 0
Physiotherapy
Public Health 329820 329820 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group exercise and education

Participants randomised to the group exercise/education group will attend six fortnightly 60-minute group exercise/education sessions over 12 weeks at a single physiotherapy clinic. Participants will complete a total of three exercise sessions per week, including the 6 supervised sessions, with the remaining sessions to be completed independently at home.

Prior to commencing the group exercise sessions, a single session of education (30 minutes) will be provided via a pre-recorded video sent to participants. The education session will include education regarding i) shoulder anatomy and causes of RCRSP and rotator cuff tendinopathy, ii) tissue changes are a normal part of healthy ageing, iii) factors that may worsen, or improve, shoulder pain and function, iv) monitoring pain during exercise and how much pain is acceptable, v) activity modification during activities of daily living and exercise, vi) prognosis, and vii) general physical activity recommendations. Prior to commencing group exercise classes, participants will attend a teleconference (Zoom) session where they will have an opportunity to ask questions. The video and teleconference session will be provided by a physiotherapist.

Exercise fidelity will be assessed by audio recording sessions.

There will be a maximum of four participants in each group. Group exercise will be supervised the same physiotherapist. The exercise program will be progressive and consist of shoulder exercises focusing on elevation, external rotation, pushing and pulling, using body weight, hand weights and resistance bands. Shoulder exercise will comprise of three sets of 15 repetitions and four seconds per cycle for isotonic exercise (two second concentric and two second eccentric phase) or six sets of 30 seconds if isometric exercise is commenced initially.

Participants will progress through pre-determined levels of difficulty based on achieving the prescribed dosage (sets, repetitions, time under tension). Exercise difficulty and load will be progressed, or regressed, so that fatigue is achieved after the prescribed number of repetitions.

The physiotherapist providing care will receive training from researchers (1 x 1.5 hour training session on site) in how to prescribe and monitor the exercises in a standardised way prior to the study commencing.

Adherence to home-based exercise will be monitored with an exercise diary, completed by participants.
Intervention code [1] 326938 0
Rehabilitation
Intervention code [2] 328130 0
Treatment: Other
Comparator / control treatment
Comparator 1: Usual care (reference comparator)

Participants randomised to the usual care group will receive six sessions of individual physiotherapy care over 12 weeks in a separate physiotherapy clinic. Care will be provided by qualified physiotherapists matched in years of experience to the physiotherapist providing group exercise/education.

Usual care is defined as any care that is within the scope of practice of a physiotherapist and as determined by the treating physiotherapist. No limitations will be placed on the number or length of appointments or the type of interventions provided. The type, duration and frequency of treatment will be recorded by interviewing treating physiotherapists.


Comparator 2: Active control

Participants randomised to the active control group will be provided with advice and education delivered using a website that has been developed for the trial (https://shouldercareaustralia.com/). Participants will receive access to the website when they are randomised to this group.

Participants will receive advice and education about rotator cuff related shoulder pain, activity modification, modifying general and work-related activity and pain medications as per recommended care.

The minimum time participants will be asked to spend reading and applying the education materials is 30 minutes per week. Adherence within the active control group will be encouraged through weekly emails to participants from researchers. Adherence will be monitored by recording the time each participant accessed the website for and webpages viewed, using a unique login code given to each participant.
Control group
Active

Outcomes
Primary outcome [1] 335992 0
Feasibility

Feasibility will be determined by calculating the compliance rate with the intervention (% of exercise and education sessions attended) in the group exercise/education group.
Timepoint [1] 335992 0
6 and 12 weeks after the commencement of the intervention
Primary outcome [2] 335993 0
Clinical outcome: Shoulder pain and function (composite outcome) will be measured with the shoulder pain and Disability Index (SPADI), a validated questionnaire that has been used extensively among people with rotator cuff related shoulder pain.
Timepoint [2] 335993 0
At baseline and at 6 and 12 weeks after the commencement of the intervention
Secondary outcome [1] 426390 0
Feasibility – recruitment (composite outcome)
Feasibility will be determined by i) the number of eligible participants who make contact, and ii) the rate of recruitment (the number of participants recruited per month). Eligibility and enrolment data will be determined by an audit of study-specific screening and enrolment logs.
Timepoint [1] 426390 0
At baseline and at 6 and 12 weeks after the commencement of the intervention
Secondary outcome [2] 426391 0
Feasibility – conversation and retention (composite outcome)
The conversion rate will be determined by calculating the proportion of participants providing consent from those who met the eligibility criteria. The rate of retention will be determined by the number of participants completing the 12 week pilot trial.
Timepoint [2] 426391 0
At baseline and at 6 and 12 weeks after the commencement of the intervention
Secondary outcome [3] 426430 0
Feasibility -response rate to questionnaires
The number of participants completing all questionnaires at 6 and 12 weeks after the commencement of the intervention will be calculated
Timepoint [3] 426430 0
At baseline and at 6 and 12 weeks after the commencement of the intervention
Secondary outcome [4] 426433 0
Adverse events

Adverse events from the interventions (group exercise, usual care or active control) will be assessed using a Qualtrics survey™.

Participants will be asked to document the type of adverse event (e.g. exacerbation of shoulder pain), the body location, the duration, and severity of the event (i.e., mild, moderate, or severe). An independent assessor will assess all adverse events as unrelated, probably related or definitely related, and only those considered to be probably or definitely related will be considered an adverse event. Serious adverse events will be defined as events that are life-threatening, require hospitalisation, or result in persistent or significant difficulty or incapacity. An open-response type format will also be available for participant responses. The rate of adverse events will be considered acceptable if less than 15% and none are considered serious.
Timepoint [4] 426433 0
At 6 and 12 weeks after the commencement of the intervention
Secondary outcome [5] 426435 0
Global rating of change

Participant's rating of change for each intervention will be measured with the Patient Global Impression of Change (PGIC) questionnaire.
Timepoint [5] 426435 0
At 6 and 12 weeks after the commencement of the intervention
Secondary outcome [6] 426436 0
Overall pain intensity

Participant’s perception of their overall shoulder pain intensity will be measured using a 100 mm visual analogue scale (VAS), participants will rate the worst pain during the last week (zero = no pain; 100 = worst pain possible).
Timepoint [6] 426436 0
At baseline and at 6 and 12 weeks after the commencement of the intervention
Secondary outcome [7] 426437 0
Health-related quality of life

Health-related quality of life will be measured with the EuroQol 5D-5L, a validated and reliable tool including five domains (mobility, selfcare, usual activities, pain/discomfort, and anxiety/depression).
Timepoint [7] 426437 0
At baseline and at 6 and 12 weeks after the commencement of the intervention
Secondary outcome [8] 432431 0
Kinesiophobia (fear of movement)

Kinesiophobia will be measured with the Tampa Scale for Kinesiophobia (TSK) that has been validated among people with musculoskeletal pain.
Timepoint [8] 432431 0
At baseline and at 6 and 12 weeks after the commencement of the intervention
Secondary outcome [9] 432432 0
Work productivity (economic evaluation)

Work productivity will be assessed with the Work Productivity and Activity Impairment Questionnaire (WPAI).
Timepoint [9] 432432 0
At baseline and at 6 and 12 weeks after the commencement of the intervention

Eligibility
Key inclusion criteria
Participants will be included if the following criteria are satisfied: (i) 18 years of age or older; (ii) primary complaint of anterolateral shoulder pain (with or without referral into the arm) for eight or more weeks; (iii) preserved passive shoulder range; (iv) shoulder pain related to movement or resisted muscle contraction (e.g. empty/full can tests).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with any of the following conditions will be excluded: (i) massive rotator cuff tendon tear of two or more tendons (based on clinical presentation or imaging if available); (ii) gross shoulder instability; (iii) significant shoulder trauma (e.g. previous fracture); (iv) previous shoulder surgery; (v) shoulder osteoarthritis (glenohumeral or acromioclavicular); (vi) hemiplegic shoulder; (vii) a complex myofascial neck/shoulder/arm pain condition; (viii) suspected cervical spine referred pain; or (ix) a systemic inflammatory condition (e.g. rheumatoid arthritis).

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)
A researcher who is not involved in the screening process and checking eligibility will undertake randomisation of participants into groups 1, 2 and 3.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised into three permuted blocks (groups 1, 2 or 3) in groups of four. The randomisation sequence will be created using computer software (i.e. computerised sequence generation). Stratification for sex or other characteristics will not be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/04/2024
Actual
10/05/2024
Date of last participant enrolment
Anticipated
17/07/2024
Actual
Date of last data collection
Anticipated
9/10/2024
Actual
Sample size
Target
36
Accrual to date
32
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 314106 0
Charities/Societies/Foundations
Name [1] 314106 0
Physiotherapy Research Foundation
Country [1] 314106 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 316023 0
None
Name [1] 316023 0
Address [1] 316023 0
Country [1] 316023 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313246 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 313246 0
Ethics committee country [1] 313246 0
Australia
Date submitted for ethics approval [1] 313246 0
21/09/2022
Approval date [1] 313246 0
03/10/2022
Ethics approval number [1] 313246 0
32126

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

Contacts
Principal investigator
Name 127466 0
Dr Luke Perraton
Address 127466 0
Department of Physiotherapy | School of Primary and Allied Health Care Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 127466 0
Australia
Phone 127466 0
+61418306533
Fax 127466 0
Email 127466 0
[email protected]
Contact person for public queries
Name 127467 0
Luke Perraton
Address 127467 0
Department of Physiotherapy | School of Primary and Allied Health Care Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 127467 0
Australia
Phone 127467 0
+61418306533
Fax 127467 0
Email 127467 0
[email protected]
Contact person for scientific queries
Name 127468 0
Luke Perraton
Address 127468 0
Department of Physiotherapy | School of Primary and Allied Health Care Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 127468 0
Australia
Phone 127468 0
+61418306533
Fax 127468 0
Email 127468 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?
All outcome data
When will data be available (start and end dates)?
Upon request at any time. Data will be made available from September 2024. No end date is determined.
Available to whom?
Researchers
Available for what types of analyses?
Meta-analysis
How or where can data be obtained?
From the lead researcher. Data will be made available by emailing the lead researcher ([email protected])


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.