Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000353493
Ethics application status
Approved
Date submitted
13/02/2025
Date registered
23/04/2025
Date last updated
23/04/2025
Date data sharing statement initially provided
23/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Remote Alexa-based care versus telehealth (via zoom) and active control for rotator cuff tendinopathy: a pilot and feasibility randomised controlled trial
Scientific title
Remote Alexa-based care versus telehealth (via zoom) and active control for rotator cuff tendinopathy: a pilot and feasibility randomised controlled trial
Secondary ID [1] 313960 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff tendinopathy 336679 0
Rotator cuff related shoulder pain 336680 0
Condition category
Condition code
Musculoskeletal 333180 333180 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 333181 333181 0 0
Physiotherapy
Public Health 333182 333182 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group (iii) Digital voice assisted (DVA) care will complete a simple exercise regime along with educational videos delivered via Alexa voice and video, which is interactive and individualized, with asynchronous physiotherapist support.

The intervention period for this study will last 12 weeks.

The education components involves education and advice regarding the pathology, modification of actives of daily living, and encouragement to stay active. This will be delivered across the first week of the program in 3 x 5-10 minutes videos. The videos will be available at any time during the intervention, and participants will be prompted to return to the videos if they have an increase in pain or is unable to complete the exercise program.

The exercise regime comprises of three exercises - one push, one pull, and one elevation exercise. Three sets of 8-12 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 8-12). If they are able to complete more, then they should increase the exercise intensity and there will is prompts to suggest how to do that. 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, ie 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 will be encouraged to complete their exercise regime at least three times per week. We estimate each session with take approximately 10-15 minutes.

Adherence will be evaluated as percent of prescribed sessions completed (via email questionnaire at 6 weeks and 12 weeks. Adherence will be categorised as: (i) poor: 75%.

At the end of each session participants will be prompted to volunteer any issues they are having or to request contact from their assigned physiotherapist via a phone call or email. Transcripts of interactions between Alexa and the user will also be reviewed asynchronously (on a weekly basis) by a physiotherapist who will be able to contact the participant via email or phone to resolve any issues. If the participants has been not interacted with the Alexa device for a week (the physiotherapist will email or call to enquire if there are any issues).
Intervention code [1] 330552 0
Rehabilitation
Comparator / control treatment
Group (i) Active control (activity modification & medication advice) via an electronic leaflet including text and infographics created in collaboration with Monash University designers and has been tested in a prior trial (ACTRN12621001650886) and adapted based on patient feedback. This will be emailed to participants in this group at the start of the intervention period.

The leaflet will include information regarding shoulder anatomy, the meaning of pain, acceptable pain during shoulder exercises and other activities, signs and symptoms of rotator cuff tendinopathy, advice about managing pain, advice about modifying activities that may be painful or provocative, treatments offered including exercise and advice, injections and wait and see, benefits and harms of these treatments, factors that are thought to cause rotator cuff tendinopathy, advice about returning to shoulder activities that may have been stopped or modified, and advice about dealing with flare ups. Participants will need to engage with the leaflet for 15-30 minutes.

Group (ii) Synchronous based care (delivered via video conferencing) including simple exercises and education to address patient beliefs delivered via 6 x 1 hour group video conferencing sessions over the 12-week period. This session will include 20 minutes of education and discussion time, and 40 minutes of exercise prescription and completion. This group will complete the same exercises as Group iii and be provided with the same educational content. There will be 3 participants to 1 physiotherapist. Attendance at each session will be recorded.

The same physiotherapist will monitor Group iii and provide synchronous based care to Group ii. The physiotherapist providing care will receive training from researchers (2 x 1.5 hour training session on site) in how to prescribe and monitor the exercises in Group ii.
Control group
Active

Outcomes
Primary outcome [1] 340737 0
Feasibility - Study processes: (i) the number of eligible participants who make contact and the rate of recruitment; (ii) rate of retention; and (iii) response rates to questionnaire outcomes. This will be assessed as a composite outcome.
Timepoint [1] 340737 0
(i) Baseline (ii) Following the 12-week intervention period (iii) Baseline, 6 and 12 weeks after the commencement of the intervention, and 12, 24 and 52 weeks following the intervention period.
Primary outcome [2] 340738 0
Feasibility - Adherence: % of prescribed sessions completed. Adherence will be categorised as: (i) poor: 75%.
Timepoint [2] 340738 0
6 and 12 weeks after the commencement of the intervention.
Primary outcome [3] 340741 0
Feasibility - Adverse events.
Timepoint [3] 340741 0
6 and 12 weeks after the commencement of the intervention, and 12, 24 and 52 weeks following the intervention period.
Secondary outcome [1] 444971 0
Economic evaluation - Medical Benefits Schedule (MBS) and Pharmaceutical Benefits Schedule (PBS) participant data. This will be assessed as a composite outcome.
Timepoint [1] 444971 0
52 weeks following the intervention period.
Secondary outcome [2] 444972 0
Economic evaluation - Work productivity
Timepoint [2] 444972 0
12, 24 and 52 weeks following the intervention period.
Secondary outcome [3] 444973 0
Economic evaluation - Health care use
Timepoint [3] 444973 0
12, 24 and 52 weeks following the intervention period.
Secondary outcome [4] 444974 0
Primary clinical outcome - Pain and function. This will be assessed as a composite outcome.
Timepoint [4] 444974 0
Baseline, 12 weeks after the commencement of the intervention, and 24 and 52 weeks following the intervention period.
Secondary outcome [5] 444975 0
Global rating of change
Timepoint [5] 444975 0
12 weeks after the commencement of the intervention, and 24 and 52 weeks following the intervention period.
Secondary outcome [6] 444976 0
Overall pain intensity
Timepoint [6] 444976 0
Baseline, 12 weeks after the commencement of the intervention, and 24 and 52 weeks following the intervention period.
Secondary outcome [7] 444977 0
Health-related quality of life
Timepoint [7] 444977 0
Baseline, 12 weeks after the commencement of the intervention, and 24 and 52 weeks following the intervention period.
Secondary outcome [8] 444978 0
Kinesiophobia (fear of movement)
Timepoint [8] 444978 0
Baseline, 12 weeks after the commencement of the intervention, and 24 and 52 weeks following the intervention period.
Secondary outcome [9] 444979 0
Experiences with the internet interventions and telerehabilitation support
Timepoint [9] 444979 0
6 and 12 weeks after the commencement of the intervention

Eligibility
Key inclusion criteria
Participants will be included if they are 18-75 years of age and answer yes to the following questions; (i) is your shoulder pain your primary complaint? (ii) is your shoulder pain worse when lifting your arm above your head?; (iii) are you able to raise your arm to the level of your shoulder or higher?
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 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 (or on both sides if you have shoulder pain on both sides)? Participants will also be excluded if they answer no to the following question (i) do you have access to a home wi-fi network?

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 i, ii and iii.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The telehealth via video conferencing (group ii) is a group intervention with three participants to every therapist. Therefore, participants will be randomized in groups of nine (3 to each intervention group). 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
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318458 0
Charities/Societies/Foundations
Name [1] 318458 0
Physiotherapy Research Foundation
Country [1] 318458 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 320855 0
None
Name [1] 320855 0
Address [1] 320855 0
Country [1] 320855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317073 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 317073 0
Ethics committee country [1] 317073 0
Australia
Date submitted for ethics approval [1] 317073 0
14/12/2023
Approval date [1] 317073 0
29/02/2024
Ethics approval number [1] 317073 0
37946

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

Contacts
Principal investigator
Name 139910 0
Dr Peter Nicklen
Address 139910 0
Department of Physiotherapy | School of Primary and Allied Health Care Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 139910 0
Australia
Phone 139910 0
+61 403367344
Fax 139910 0
Email 139910 0
[email protected]
Contact person for public queries
Name 139911 0
Peter Nicklen
Address 139911 0
Department of Physiotherapy | School of Primary and Allied Health Care Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 139911 0
Australia
Phone 139911 0
+61 403367344
Fax 139911 0
Email 139911 0
[email protected]
Contact person for scientific queries
Name 139912 0
Peter Nicklen
Address 139912 0
Department of Physiotherapy | School of Primary and Allied Health Care Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 139912 0
Australia
Phone 139912 0
+61 403367344
Fax 139912 0
Email 139912 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: From the lead researcher. Data will be made available by emailing the lead researcher ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.