Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001648112
Ethics application status
Approved
Date submitted
15/11/2019
Date registered
26/11/2019
Date last updated
3/06/2021
Date data sharing statement initially provided
26/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Telerehabilitation and internet-based management of rotator cuff related pain: a pilot and feasibility randomised controlled trial
Scientific title
Telerehabilitation and internet-based management of rotator cuff related pain: a pilot and feasibility randomised controlled trial
Secondary ID [1] 299820 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Related Pain 315200 0
Condition category
Condition code
Musculoskeletal 313519 313519 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be delivered via a tailored online website for participants.
The intervention groups include:
*Group (ii): Detailed education, advice and exercises + “virtual physiotherapist” (performance of exercises is entered into a website and it provides guidance for modification)
*Group (iii): Detailed education, advice and exercises + “virtual physiotherapist” + weekly telerehabilitation session via Zoom with physiotherapist.

We hypothesize the addition of a weekly telerehabilitation session for Group (iii) will improve the personalization and personability of the program while still using an online platform. We anticipate this will improve adherence to the program and result in superior results of primary and secondary outcomes in group (iii) compared to group (i) and group (ii).

The online website has been specifically designed for this trial. It is built to encourage self-navigation throughout the website. The online website was built by an IT expert in conjunction with a physiotherapy shoulder expert.
It will include the education material, which is a document around rotator cuff related pain including anatomy, physiology, contributing factors, treatment and advice including activity modification and recommended care. This is provided in both written and video format.
It also includes the exercise intervention, which is provided in both written and video exercises. There will be two exercises: shoulder elevation in standing; and shoulder external rotation in side-lying. Three sets of 15 repetitions of each exercise will be performed. The exercise will be individualised based on pain (pain should be minimal during the exercise, i.e. less than 5/10 on a 10-point numerical rating scale), and capacity (they should feel they are not able to perform more than 2 additional repetitions at the end of each set of 15). Participants are encouraged to modify the exercises (either make easier or more difficult) as per their self-perceived levels of pain. If they find the exercise too easy, they are prompted to increase the exercise intensity by adding external load in increments of 1kg. Each day they should ensure that they can perform the exercise with acceptable pain (<5/10). If this is not the case they will be advised to regress, i.e. reduce the weight, or revert to an isometric holding exercise (holding a weight statically). If there is still unacceptable pain (5/10 or above) they will be advised to rest for that day.

Participants are required to complete their exercises daily, unless their pain symptoms guide them to rest for the day and try again the following day. Participants in group (ii) and group (iii) are expected to enter what exercises they completed (and any modifications) into a daily recording page within the website. This will track adherence to the program and allow the monitoring of progression of exercise and participation throughout the trial.

All participants will be required to complete an online survey at baseline, at six weeks and at twelve weeks at the conclusion of the study. Participants will be required to complete an initial baseline Zoom session, and participants in group three will be required to complete a weekly telerehabilitation session. This weekly telerehabilitation session will be completed via Zoom, an online videoconference platform. It will be set up at an agreed upon time between the physiotherapist and the participant. The aim of the session is to assess exercise technique, suggest progressions if indicated and answer any participant questions. It is expected to take between 10-30 minutes per week.

Participants will be provided with education at baseline and required to complete a questionnaire regarding this education to measure knowledge improvement. The education intervention has been developed with input from multidisciplinary expert shoulder clinicians.
Intervention code [1] 316080 0
Rehabilitation
Comparator / control treatment
The control group is described as *Group (i): Basic education for rotator cuff related pain. They will utilise the online website, but have restricted access to only basic shoulder pain education, comparatively to the detailed education of Group (ii) and Group (iii). They are not required to enter their progress into the online server.
All participants will be required to complete an online survey at baseline, at six weeks and at twelve weeks at the conclusion of the study. Participants will be required to complete an initial baseline Zoom session.
Control group
Active

Outcomes
Primary outcome [1] 321971 0
Pain and function: Measured with the shoulder Pain and Disability Index (SPADI), a validated questionnaire that has been used extensively among people with rotator cuff tendinopathy.
Timepoint [1] 321971 0
0, 6, 12 weeks.
Secondary outcome [1] 376863 0
The Global Rating of Change Score (GRoC); a frequently used outcome measure that has been used to independently score self-perceived improvement in a patient's overall symptoms and function.
Timepoint [1] 376863 0
0,6, 12 weeks.
Secondary outcome [2] 376864 0
Health-related quality of life: Measured with the EuroQol 5D-5L, a validated and reliable tool, including five domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression).
Timepoint [2] 376864 0
0, 6, 12 weeks
Secondary outcome [3] 376865 0
Kinesiophobia (fear of movement): Measured with the Tampa Scale for Kinesiophobia (TSK) that has been validated among people with musculoskeletal pain
Timepoint [3] 376865 0
0, 6, 12 weeks
Secondary outcome [4] 376866 0
The General Self-Efficacy Scale is a scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life.
Timepoint [4] 376866 0
0, 6, 12 weeks
Secondary outcome [5] 376869 0
Work Productivity and Activity Impairment Questionnaire: the effect of your health problems on your ability to
work and perform regular activities
Timepoint [5] 376869 0
0, 6, 12 weeks
Secondary outcome [6] 376870 0
Use of other healthcare services: a self-report of the use of other healthcare services while completing the program
Timepoint [6] 376870 0
6, 12 weeks

Eligibility
Key inclusion criteria
Participants will be eligible for inclusion if they answer yes to the following questions;
*Do you have pain when lifting your arm above your head?
*Is your pain mostly at the front and side of your shoulder?
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they answer yes to any of the following questions: (i) is your shoulder pain made worse by neck movement? (ii) has your shoulder pain been diagnosed as a frozen shoulder or instability by a health professional? (iii) have you already undertaken more than 12 weeks of exercise but have not had any imaging? (if they answer yes to this question they will be recommended to visit their doctor who may instigate imaging or specialist referral and per current guidelines); (iv) have you been told you have inflammatory arthritis by a health professional? (v) have you previously had shoulder surgery on your currently painful shoulder?

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)
Participants will be unaware of their randomization to one of three groups. This will be done by random sequential computer software after screening for eligibility.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple sequence randomisation created by computer software.
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
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 whether to proceed to a full-scale trial: (i) Recruitment rates: Consent and randomisation of 20% or more of eligible
patients. (ii) Intervention adherence: 70% or more of the number of sessions completed in each group; (iii) follow-up rates of internet questionnaire outcomes of 70% or more. This feasibility trial will not be powered to identify treatments effects, 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
Completed
Date of first participant enrolment
Anticipated
8/01/2020
Actual
2/03/2020
Date of last participant enrolment
Anticipated
22/01/2020
Actual
20/03/2020
Date of last data collection
Anticipated
15/04/2020
Actual
19/06/2020
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 28465 0
3199 - Frankston

Funding & Sponsors
Funding source category [1] 304281 0
Charities/Societies/Foundations
Name [1] 304281 0
Arthritis Australia
Country [1] 304281 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Peninsula Campus
Moorooduc Highway
Frankston VIC 3199
Country
Australia
Secondary sponsor category [1] 304524 0
None
Name [1] 304524 0
Address [1] 304524 0
Country [1] 304524 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304738 0
Monash Human Research Ethics Committee
Ethics committee address [1] 304738 0
Ethics committee country [1] 304738 0
Australia
Date submitted for ethics approval [1] 304738 0
12/11/2019
Approval date [1] 304738 0
15/11/2019
Ethics approval number [1] 304738 0
22364

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

Contacts
Principal investigator
Name 98038 0
A/Prof Peter Malliaras
Address 98038 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 98038 0
Australia
Phone 98038 0
+61399044502
Fax 98038 0
Email 98038 0
[email protected]
Contact person for public queries
Name 98039 0
Peter Malliaras
Address 98039 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 98039 0
Australia
Phone 98039 0
+61399044502
Fax 98039 0
Email 98039 0
[email protected]
Contact person for scientific queries
Name 98040 0
Peter Malliaras
Address 98040 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 98040 0
Australia
Phone 98040 0
+61399044502
Fax 98040 0
Email 98040 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.