Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000248965
Ethics application status
Approved
Date submitted
17/02/2020
Date registered
26/02/2020
Date last updated
6/05/2021
Date data sharing statement initially provided
26/02/2020
Date results provided
6/05/2021
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] 300581 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator Cuff Tendinopathy 316317 0
Condition category
Condition code
Musculoskeletal 314583 314583 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are three groups in total
(i) standard advice and exercise via online printable pamphlet (comparator);
(ii) A combination of online printable pamphlet and video, plus a "virtual physiotherapist" whereby participants enter their exercise and symptoms into the website and it tailors their exercise;
(iii) A combination of online printable pamphlet, video and "virtual physiotherapist"
plus a weekly telerehabilitation session with a physiotherapist.

Education will be identical in all groups, only the delivery mode will differ. The education pamphlet and information has been custom designed for this study. Education will include the causes, pain mechanisms, exercise treatments and their efficacy and mechanisms, and other treatments and their efficacy. Emphasis will be placed on addressing knowledge gaps and barriers and enablers to recommended care. For example, challenging participants’ understanding of the relevance of tendon structure and imaging, expectations from exercise interventions, and pain and exercise self-efficacy. In each group participants will have free access to the pamphlet (group 1), pamphlet and videos (group 2/3) to watch as many times as they desire we advise that they watch the videos at least 1-2 times to comprehend the advice and instructions). The pamphlet is designed in landscape A4 pages and there is a series of 3-7 minute videos totalling approximately minutes. The inidvidualised exercise feedback in groups 2/3 is provided via an online computer algorithm in response to the level of pain and fatigue the participants reports after each set of exercise.

Exercise intervention: This will be identical in groups 2/3 (group 1 does not undertake exercise), only the delivery mode will differ. The deliver of exercise will be soley online for group 2, whereas group 3 will receive the online information and thsi will be supplemented by the weekly telerehabilitation session where the exercise instructions will be reiterated. The intervention will only include 2 exercise: 1) shoulder elevation (from 10-150 degrees because extremes are usually provocative); and 2) external rotation (full range). Elevation can be performed into shoulder abduction, scaption or flexion, depending on acceptable pain response (pain that is 'minimal' or less than 5/10 with activity and any increase in pain after exercise settles to pre-exercise levels relatively quickly ie within 12-24 hours). If pain during exercise is beyond 5/10 participants are advised to reduce weight, repetitions or range of motion until pain response is acceptable, or revert to isometric hold exercise until pain with through range exercise is acceptable. Exercise will be performed three times per week over 12 weeks (3 sets of 15 repetitions and 4 seconds per cycle for isotonic exercise [2 second concentric and 2 second eccentric phase] or 6 sets of 30 seconds if isometric exercise is commenced initially). Exercise progression will be based on 1) achieving the prescribed dosage (sets, repetitions, time under tension) if this is not possible initially due to pain response or fatigue; 2) Then progressing load using a hand-held weight so that fatigue is achieved after 14-16 repetitions (otherwise they will be encouraged to use a heavier or lighter weight). Participants will be provided with education about how to progress and regress exercise based on acceptable pain response. Participants will be advised to increase exercise exetrnal load if pain during exercise is acceptable and muscular fatigue is not experienced after the allocated repetitions. Regression (reduced load) will occur if pain is beyond what has been defined as acceptable. If the participant is not using a weight they regression will involve reducing the repetitions or range of motion, or reverting to an isometric hold exercise.

To maximise adherence with the exercise, participants in groups 2/3 will receive weekly emails (via Mailchimp) that are designe to remind and encourage them. There is also a link to contact the trial staff if they have any issues. Another adherence strategies is a log if exercise online for groups 2/3. As they complete each set they log how many repetitions they were able to do and their symptoms.

The exercise and education components have been designed by board certified physiotherapists based on expert consensus and available evidence. They will be delivered completely remotely, without any clinician input or guidance, aside from the weekly telerehabilitation session in group 3.

Weekly telerehabilitation: In Group 3, participants will also receive a weekly group telerehabilitation session with a physiotherapist, via a custom telerehabilitation platform (NeoRehab). There will be 3-4 participants in each group. This first 2 sessions will take 60 minutes, then 30 minutes for the remaining weeks. The session will be undertaken
at a time that suits all the members of the group. During these sessions participants will be asked whether they have had any issues completing their exercise, whether they need assistance with modification of their activity. The education content will be reviewed in each telerehab session with particular focus on aspects that the participants would like to review.
Intervention code [1] 316888 0
Rehabilitation
Intervention code [2] 316935 0
Treatment: Other
Comparator / control treatment
Group 1 described above is the comparator group
Control group
Active

Outcomes
Primary outcome [1] 322910 0
Study processes: This is a composite outcome for study feasibility. The following outcomes will be used to determine feasibility (yes, no, modification required) for a substantive randomised controlled trial: (1) the number of eligible participants who make contact and the rate of recruitment; (2) acceptable exercise adherence (% of prescribed exercise completed); (3) rate of retention; (4) response rates to questionnaire outcomes; and (5) incidence of adverse events (measured via a study sepcific questionnaire)
Timepoint [1] 322910 0
12 weeks for retention and response rate to questionnaires
Primary outcome [2] 322911 0
Adherence: Via a custom questionnaire at 6 and 12 weeks (1 email and 2 phone-call reminders within a week for non-responders) and is defined as the percentage of prescribed exercise sessions completed per week.
Timepoint [2] 322911 0
4, 8 and 12 weeks (email questionnaires)
Primary outcome [3] 322912 0
Adverse events: This is a composite outcome: An adverse event is defined as any unfavourable or unintended diagnosis, sign, symptom, or disease associated with the study which may or may not be related to the intervention (e.g. tendon rupture, fall, injury, or change in medical status).
• Tendinopathy-related adverse events: Tendon pain and swelling is anticipated in people with Achilles tendinopathy, and discomfort with treatment is expected as part of the routine healing process. A tendon related adverse event will be defined by the participant’s inability to participate in the physical therapy intervention for at least 7 consecutive days due to tendon pain or swelling.
• A serious adverse event is defined as an event related or not related to the intervention that results in death, life-threatening complication, hospitalization, 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 adverse events include but are not limited to surgery for tendon rupture, heart attack requiring overnight hospitalization
The frequency (number of participants and number of cases), cause and type (e.g. tendon rupture) of adverse events over the last four weeks will be recorded by making a yes/no response and then using an open-response questionnaire.
Timepoint [3] 322912 0
4, 8 and 12 weeks (email questionnaires)
Secondary outcome [1] 380217 0
Data for economic evaluation: This is a composite secondary outcome. The use of health services and co-interventions will be measured using a patient questionnaire. Work productivity will be assessed with the Work Productivity and Activity Impairment Questionnaire (WPAI). Health care use and productivity will be assessed questionnaire at 4, 8 and 12 weeks. Ability to collect these outcomes will determine feasibility of an economic evaluation in the main trial.
Timepoint [1] 380217 0
4, 8 and 12 weeks (email questionnaires)
Secondary outcome [2] 380218 0
Pain and function: This is a composite secondary outcome combining pain and function domains. Measured with the shoulder Pain and Disability Index (SPADI), a validated questionnaire that has been used extensively among people with rotator cuff tendinopathy.
Timepoint [2] 380218 0
0, 6 and 12 weeks (emails questionnaire)
Secondary outcome [3] 380219 0
Global rating of change: Measured using the Patient Global Impression of Change (PGIC) 7-point Likert scale. Participants are asked to rate how their shoulder pain has changed since receiving the intervention.
Timepoint [3] 380219 0
6 and 12 weeks (email questionnaire)
Secondary outcome [4] 380220 0
Overall pain intensity: Measured using the 100 mm visual analogue scale (VAS), participants will rate the worst pain during the last week (zero = no pain; 100 = worst pain possible)
Timepoint [4] 380220 0
0, 6 and 12 weeks (emails questionnaire)
Secondary outcome [5] 380221 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 [5] 380221 0
0, 6 and 12 weeks (emails questionnaire)
Secondary outcome [6] 380222 0
Kinesiophobia (fear of movement): Measured with the Tampa Scale for Kinesiophobia (TSK) that has been validated among people with musculoskeletal pain.
Timepoint [6] 380222 0
0, 6 and 12 weeks (emails questionnaire)
Secondary outcome [7] 380223 0
Catastrophising: The Pain Catastrophising Scale is a validated questionnaire used to measure pain catastrophisation..
Timepoint [7] 380223 0
0, 6 and 12 weeks (emails questionnaire)
Secondary outcome [8] 380224 0
Pain self efficacy: Assessed with the pain self-efficacy questionnaire (PSEQ). The PSEQ measures how confident a patient is in undertaking a range of activities despite their pain.
Timepoint [8] 380224 0
0, 6 and 12 weeks (email questionnaire)

Eligibility
Key inclusion criteria
Participants will be included if they are over the age of 18 and answer apporopriately (indicated in brackets) to the following screening questions; Has your shoulder problem been diagnosed as 'frozen shoulder' or 'adhesive capsulitis' (NO); Has your shoulder problem been diagnosed as 'osteoarthritis', 'arthritis' or a problem with the 'labrum' (NO); Has your shoulder problem been diagnosed as 'instability' (NO); Is your shoulder pain a result of a shoulder dislocation (NO); Are you 18 years old or older (YES); Have you had your current shoulder pain for 8 weeks or longer (YES); Is your shoulder pain MAINLY around the area as shown in the photos below? (YES); Is your shoulder pain made worse by neck movement (NO); Is your shoulder pain brought on by moving your arm above your head (YES); Are you able to lift your arm to the height shown in the photo below (YES).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: Participants will be excluded if they answer yes to the following questions: Have you had ever had surgery for the shoulder that is currently painful or the most painful (if both sides hurt); Did your current shoulder pain result from trauma such as a fall; Do you have swelling and pain in multiple joints; Have you ever had a fever associated with your shoulder pain; Have you had recent unexplained weight loss; Do you have constant pins and needles or numbness in ANY of your hands, feet, or groin region; Do you have bowel / bladder problems, such as weakness or retention; Have you had a sudden change in your bowel habits, such as severe constipation; I am severely depressed; (x) I am taking recreational drugs; I am taking/have taken corticosteroids; I have/have had angina or heart problems; since my shoulder problem started I have had a sudden onset of severe, steady and worsening abdominal and upper back pain; I have had cancer at some time in the past; I am on Warfarin or another 'blood thinner'; I have recently had ANY OF dizziness, blurred vision, slurred speech, difficulty swallowing, falls or unsteadiness; I have recently had seizures.

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)
We will utilise a Zelen randomisation process. All consenting participants will initially be allocated to group 1. They will then all be screened via a telerehabilitation to call check their eligibility. After this, a random selection of people will be invited via an email to have the additional interventions in group 2 or 3. A researcher who is not involved in the telerehabilitation calls checking eligibility will undertake randomisation into groups 2 and 3.

The reason for using a Zelen design is that there is a real risk that group 1 will have high attrition rates if they are aware they have received an inferior intervention.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A researcher who is not involved in the telerehabilitation calls checking eligibility will undertake randomisation into groups 2 and 3. The randomisation sequence will be created using computer software (i.e. computerised sequence generation).
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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2020
Actual
16/03/2020
Date of last participant enrolment
Anticipated
16/03/2020
Actual
30/03/2020
Date of last data collection
Anticipated
15/06/2020
Actual
30/06/2020
Sample size
Target
36
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 305002 0
Charities/Societies/Foundations
Name [1] 305002 0
Arthritis Australia
Country [1] 305002 0
Australia
Funding source category [2] 305003 0
Charities/Societies/Foundations
Name [2] 305003 0
Australian Physiotherapy Association
Country [2] 305003 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 305359 0
None
Name [1] 305359 0
Address [1] 305359 0
Country [1] 305359 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305399 0
Monash University Human Ethics Committee
Ethics committee address [1] 305399 0
Ethics committee country [1] 305399 0
Australia
Date submitted for ethics approval [1] 305399 0
30/10/2019
Approval date [1] 305399 0
15/11/2019
Ethics approval number [1] 305399 0
22364

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

Contacts
Principal investigator
Name 100246 0
A/Prof Peter Malliaras
Address 100246 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 100246 0
Australia
Phone 100246 0
+61400206480
Fax 100246 0
Email 100246 0
[email protected]
Contact person for public queries
Name 100247 0
Peter Malliaras
Address 100247 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 100247 0
Australia
Phone 100247 0
+61400206480
Fax 100247 0
Email 100247 0
[email protected]
Contact person for scientific queries
Name 100248 0
Peter Malliaras
Address 100248 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 100248 0
Australia
Phone 100248 0
+61400206480
Fax 100248 0
Email 100248 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 July 2020. 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
SourceTitleYear of PublicationDOI
EmbaseInternet and Telerehabilitation-Delivered Management of Rotator Cuff-Related Shoulder Pain (INTEL Trial): Randomized Controlled Pilot and Feasibility Trial.2020https://dx.doi.org/10.2196/24311
N.B. These documents automatically identified may not have been verified by the study sponsor.