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Trial registered on ANZCTR


Registration number
ACTRN12619001358134
Ethics application status
Approved
Date submitted
18/09/2019
Date registered
3/10/2019
Date last updated
3/10/2019
Date data sharing statement initially provided
3/10/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Internet-based management of rotator cuff disease: a pilot and feasibility randomised controlled trial
Scientific title
Internet-based management of rotator cuff disease: a pilot and feasibility randomised controlled trial
Secondary ID [1] 299403 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rotator cuff tendinopathy 314468 0
Condition category
Condition code
Musculoskeletal 312801 312801 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
(i) standard advice and exercise via online pamphlet;
(ii) pamphlet in (i) + video delivery;
(iii) pamphlet in (i) & videos in (ii) and individualised daily feedback. Participants will enter their pain and fatigue following each set of exercise and will receive individualised feedback about whether they should progress or regress exercise based on this.

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 A4 pages and there is a series of <6 minute videos totally 20-30 minutes. The inidvidualised daily feedback in group 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 for all groups, only the delivery mode will differ. The intervention will include shoulder elevation (from 10-150 degrees because extremes are usually provocative) and 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 once per day 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 (elevation) or a theraband (external rotation) so that fatigue is achieved after 14-16 repetitions (otherwise they will be encouraged to use a heavier or lighter weight or theraband). Participants will be provided with education about how to progress and regress exercise based on acceptable pain response. Particioants 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.

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.
Intervention code [1] 315595 0
Rehabilitation
Comparator / control treatment
Group 1 is the comparator group
Control group
Active

Outcomes
Primary outcome [1] 321419 0
Study processes: 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.
Timepoint [1] 321419 0
12 weeks for retention and response rate to questionnaires
Primary outcome [2] 321520 0
Adherence: Via a 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] 321520 0
6 and 12 weeks
Primary outcome [3] 321521 0
Adverse events: The frequency (number of participants and number of cases), type (e.g. muscle soreness) and severity (mild, moderate or severe) via a questionnaire at 6 and 12 weeks Known/possible adverse events include muscle soreness or increased pain following exercise interventions. Adverse events will be self-reported via study-specific online questionnaire.
Timepoint [3] 321521 0
6 and 12 weeks
Secondary outcome [1] 374918 0
Economic evaluation (via monthly text/email questionnaire)
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 6 and 12 weeks. Ability to collect these outcomes will determine feasibility of an economic evaluation in the main trial.
Timepoint [1] 374918 0
12 weeks
Secondary outcome [2] 375213 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 [2] 375213 0
6 and 12 weeks
Secondary outcome [3] 375214 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] 375214 0
6 and 12 weeks
Secondary outcome [4] 375215 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 [4] 375215 0
6 and 12 weeks
Secondary outcome [5] 375216 0
Kinesiophobia (fear of movement): Measured with the Tampa Scale for Kinesiophobia (TSK) that has been validated among people with musculoskeletal pain.
Timepoint [5] 375216 0
6 and 12 weeks
Secondary outcome [6] 375217 0
Experiences with the internet interventions and telerehabilitation support: At the end of the intervention period (12 weeks), acceptability of interventions and barriers and enablers to adherence will be explored via qualitative interviews of a subsample of consenting and representative participants.
Timepoint [6] 375217 0
Beyond 12 weeks

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; (i) is your shoulder pain MAINLY around the areas shown in the photos below [anterolateral shoulder/upper arm) (YES); (ii) is your shoulder pain made worse by neck movement (NO); (iii) Is the shoulder pain made worse by moving your arm above your head (YES); (ix) Are you able to lift you arm to the height indicated in the photo (90 degrees flexion) (YES)
Minimum age
18 Years
Maximum age
No limit
Gender
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 (i) Have you had a recent trauma involving the shoulder such as a fall?; (ii) Do you have swelling and pain in multiple joints?; (iii) Have you ever had a fever associated with your shoulder pain?; (iv) Have you had recent unexplained weight loss?; (v) Do you have constant pins and needles or numbness in ANY of your hands, feet, or groin region?; (vi) Do you have bowel / bladder problems, such as weakness or retention?; (vii) Have you had a sudden change in your bowel habits, such as severe constipation?; (viii) Are you unable to move your arm at all due to pain?. (ix) I am severely depressed; (x) I am taking recreational drugs; (xi) I am taking/have taken corticosteroids; (xii) I have/have had angina or heart problems; (xiii) since my shoulder problem started I have had a sudden onset of severe, steady and worsening abdominal and upper back pain; (xiv) I have had cancer at some time in the past; (xv) I am on Warfarin or another 'blood thinner'; (xvi) I have recently had ANY OF dizziness, blurred vision, slurred speech, difficulty swallowing, falls or unsteadiness; (xvii) 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)
Participants will be randomly assigned sequentially to one of the three trial arms. Allocation concealement will occur via central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
he allocation sequence will be generated by custom built computer software embedded in the website completely independently from any of the researchers.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering 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
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 303842 0
Charities/Societies/Foundations
Name [1] 303842 0
Australian Physiotherapy Association
Address [1] 303842 0
1/1175 Toorak Rd, Camberwell VIC 3124
Country [1] 303842 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Road
Clayton
Victoria 3800
Australia
Country
Australia
Secondary sponsor category [1] 303974 0
None
Name [1] 303974 0
N/A
Address [1] 303974 0
N/A
Country [1] 303974 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304355 0
Monash University Human Ethics Committee
Ethics committee address [1] 304355 0
Wellington Road
Clayton
Victoria 3800
Australia
Ethics committee country [1] 304355 0
Australia
Date submitted for ethics approval [1] 304355 0
20/11/2018
Approval date [1] 304355 0
28/08/2019
Ethics approval number [1] 304355 0
17917

Summary
Brief summary
A recent Australia-wide survey found that many general practitioners recommend unnecessary imaging and surgical referrals for a common type of shoulder pain (rotator cuff tendinopathy). We hypothesise that educating patients with rotator cuff tendinopathy directly about their condition and recommended care has the potential to reduce nappropriate imaging and surgery, increase adherence to recommended care and ultimately improve healthcare outcomes. The proposed study is a three-arm, parallel group, pilot and feasibility randomised controlled trial. Participants will be randomised to one of three trial arms; Group (i) standard advice and exercise via online pamphlet; group (ii) pamphlet in (i) + video delivery; group (iii) pamphlet in (i) & videos in (ii) and individualised daily feedback.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96662 0
A/Prof Peter Malliaras
Address 96662 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 96662 0
Australia
Phone 96662 0
+61400206480
Fax 96662 0
Email 96662 0
peter.malliaras@monash.edu
Contact person for public queries
Name 96663 0
A/Prof Peter Malliaras
Address 96663 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 96663 0
Australia
Phone 96663 0
+61400206480
Fax 96663 0
Email 96663 0
peter.malliaras@monash.edu
Contact person for scientific queries
Name 96664 0
A/Prof Peter Malliaras
Address 96664 0
Department of Physiotherapy | School of Primary and Allied Health Care
Building B | Monash University | Peninsula Campus | Victoria, 3199 Australia
Country 96664 0
Australia
Phone 96664 0
+61400206480
Fax 96664 0
Email 96664 0
peter.malliaras@monash.edu

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 February 2020. No end date is determined.
Available to whom?
Researchers
Available for what types of analyses?
Meta-analyses
How or where can data be obtained?
From the lead researcher. Data will be made available by emailing the lead researcher (peter.malliaras@monash.edu)
What supporting documents are/will be available?
No other documents available
Summary results
No Results