Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001650886
Ethics application status
Approved
Date submitted
2/11/2021
Date registered
1/12/2021
Date last updated
27/10/2024
Date data sharing statement initially provided
1/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of ADVice Versus exercISE via telehealth on shoulder pain and disability in adults with rotator cuff tendinopathy: a randomised controlled trial (the ADVISE trial)
Scientific title
Effect of ADVice Versus exercISE via telehealth on shoulder pain and disability in adults with rotator cuff tendinopathy: a randomised controlled trial (the ADVISE trial)
Secondary ID [1] 305708 0
NA
Universal Trial Number (UTN)
U1111-1271-0540
Trial acronym
ADVISE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
rotator cuff tendinopathy 324176 0
Condition category
Condition code
Musculoskeletal 321650 321650 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ARM 2: 1 telehealth session of exercise and education
ARM 3: 6 telehealth sessions of exercise and education

Education component:
Why: to improve understanding of rotator cuff tendinopathy and how to manage it, and also to reduce common fears and misconceptions about pain and activity.
What: Comprehensive education about the rotator cuff muscles, 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, indications for a scan, 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, advice about dealing with flare ups, advice about managing associated mental health issues.
Who will provide: a registered physiotherapist
How: delivered via group telehealth. For ARM 2 and 3 there will be three participants in the group and 1 physiotherapist. Each group will receive an identical 60 minute telehealth session at baseline. ARM 3 will also receive a further five 30 minute telehealth sessions over 12 weeks (week 2,4,6,9,12).
Where: All sessions will be delivered via telehealth (Zoom). Participants will be advised to be at home or a suitable environment that is quiet and where they can have access to the equipment they may need (described below).
When and how much: ARM 2 will have a single 60 minute session where all the education is delivered. ARM 3 will have the identical session where all the education is delivered. In the subsequent 5 X 30 minute telehealth sessions the physiotherapist will engage the participants in the group regarding how they are going implementing the education and advice. For example, asking questions like: 'have you been able to modify your activity?' 'please describe what you modified?' 'any issues or questions regarding the education?' 'are you clear and comfortable about the advice about acceptable pain limits provided?'
Tailoring: at the baseline 60 minute session that both groups will have, there will be limited opportunity for tailoring. The physiotherapist may answer questions the participants have about how to apply the advice (e.g. activity modification) to themselves. In the subsequent 5 x 30 minute sessions in ARM 3 there will be opportunity for the physiotherapist to tailor advice about activity modification and resumption.
Fidelity: we will check fidelity of approx. 10-15% of classes delivered by each physiotherapist. This will be via recording the telehealth session as a video. Any modifications that we identify will be discussed within 7 days of the class with the physiotherapist. The outcome of this will be to feedback to the physiotherapist to follow the protocol where appropriate, or to adapt the protocol if positive adaptation are observed. Any adaptation to the protocol will be communicated with all physiotherapists immediately and be recorded and documented in the trial outputs.

Exercise component:
Why: Exercise is a recommended intervention for rotator cuff tendinopathy aimed to improving strength and shoulder function.
What: 5 shoulder movements including elevation, external rotation, pushing, pulling and pressing. Each movement has up to four levels of difficulty, level 1 to 4.
Materials: There will be videos of each exercise on a trial website that the participants can access. There will also be photos of each exercise and descriptions within an electronic leaflet (participants will receive the leaflet in electronic format but have the option to print it if they prefer). The exercise leaflet will contain all the advice and education about how to progress and regress the exercise, the target pain levels and intensity levels, and how often to do the exercise (all described below). All the materials are custom made/designed specifically for the study and will be provided to participants via email.
Who will provide: a registered physiotherapist.
How: delivered via group telehealth. Each group will receive an identical 60 minute telehealth session at baseline (this is the same 60 minute session described above for delivery of education - time will be allocated to exercise and education). In this session participants will be able to trial 1 exercise for each of the movements. ARM 3 will also receive a further five 30 minute telehealth sessions over 12 weeks (week 2,4,6,9,12 - the same sessions described above - time will be allocated to exercise and education). Exercise will be progressed and tailored to the participants in this arm during these sessions.
Where: All sessions will be delivered via telehealth (Zoom). Participants will be advised to be at home or a suitable environment that is quiet and where they can have access to the equipment they may need (described below).
When and how much:
Acceptable pain: Participants will be advised to ensure they have acceptable pain during exercise which is pain that is 4/10 or less on a numerical rating scale where 0=no pain and 10=maximum possible pain. If they do not prefer this style of pain rating they will be asked to ensure pain feels minimal to moderate or acceptable them.
Frequency: 3x/week for 30-minutes per session. If it so happens that the participants in ARM 3 have a 30 minute follow up telehealth session in a given week then this will count as one of their three sessions for that week.
Duration: 12 weeks
Sets and repetitions: 3 sets of eight to 12 repetitions of each exercise in each shoulder movement described above.
Advice about commencing: it is anticipated that these exercise will be new to many participants so we will advise they commence with 1-2 shoulder movements initially and build up to doing 5 as they feel comfortable over 3-4 weeks. They can choose the shoulder movements they feel most comfortable to them to start with
Intensity: the target is an exercise intensity of 6, 7 or 8 out of 10 on the OMNI resistance exercise scale by the end of the 3 sets of 12 repetitions.
Progression: if the target intensity is not being reached, the advice will be to increase external load. A prerequisite for doing this will be acceptable pain. Some participants may have modified / reduced the number of sets/repetitions or range of motion of an exercise initially due to pain or feeling unable to do more. If this is the case achieving the goal sets, repetitions and range of motion should be the first priority.
Regression: if the intensity on the OMNI scale is 9/10 or more, or the pain is more than acceptable, then the advice will be to reduce external load, or try reducing sets, repetitions or range of motion.
Equipment: all participants will be sent a packet of different strength resistance bands. They also have the preference of performing the exercise with dumbbells or other equipment they have around the home (e.g. bags of rice, empty milk cartons filled with water).
Tailoring: At the subsequent 5 x 30 minute telehealth sessions (week 2,4,6,9,12), the physiotherapist will observe the participants undertaking their exercise and make suggestions about progression and regression as appropriate.

Physiotherapist training: physiotherapists will be trained to delivery the interventions. This will consist of Zoom training sessions (1.5 hours x 2), reading the trial materials and an online quiz after the 2 training sessions. There will be regular fidelity evaluations as outlined above to ensure that ARM 2 and ARM 3 telehealth interventions are delivered with high fidelity.

Monitoring adherence: adherence will be assessed via: session attendance log and a questionnaire outcome every 6 weeks (described in detail under outcomes measures).
Intervention code [1] 322095 0
Rehabilitation
Intervention code [2] 322096 0
Behaviour
Intervention code [3] 322269 0
Treatment: Other
Comparator / control treatment
ARM 1: Advice only

Delivered via an online but printable electronic leaflet. There will be not contact with a physiotherapist in this group. The education leaflet in the control group is identical to that delivered for the intervention groups.
Control group
Active

Outcomes
Primary outcome [1] 329437 0
Shoulder pain and disability index (SPADI)
Timepoint [1] 329437 0
3 months post-intervention commencement
Secondary outcome [1] 402612 0
Shoulder pain and disability index
Timepoint [1] 402612 0
6 weeks and 12 months post-intervention commencement
Secondary outcome [2] 402613 0
Shoulder pain and disability index pain subscale
Timepoint [2] 402613 0
6 weeks, 3 and 12 months post-intervention commencement
Secondary outcome [3] 402614 0
Shoulder pain and disability index disability subscale
Timepoint [3] 402614 0
6 weeks, 3 and 12 months post-intervention commencement
Secondary outcome [4] 402616 0
Global Rating of Change (GROC), 15 point Likert scale replaced the 11 point Likert scale.
Timepoint [4] 402616 0
6 weeks, 3 and 12 months post-intervention commencement
Secondary outcome [5] 402617 0
Health-related quality of life: EuroQol 5D-5L
Timepoint [5] 402617 0
6 week, 3 and 12 months post-intervention commencement
Secondary outcome [6] 402619 0
Sleep disturbance: Insomnia Severity Index.
Timepoint [6] 402619 0
6 weeks, 3 and 12 months post-intervention commencement
Secondary outcome [7] 402620 0
Self-Efficacy Beliefs Questionnaire
Timepoint [7] 402620 0
6 weeks, 3 and 12 months post-intervention commencement
Secondary outcome [8] 402621 0
Kinesiophobia - Tampa kinesiophobia Scale
Timepoint [8] 402621 0
6 weeks, 3 and 12 months post-intervention commencement
Secondary outcome [9] 402622 0
Rotator cuff related pain knowledge questionnaire

(Phillips, R., Perraton, L., Cridland, K., Maloney, S., Harris, I.A. and Malliaras, P., 2021. Patient knowledge of rotator cuff related shoulder pain condition and treatment and validation of a patient-reported knowledge questionnaire. Musculoskeletal Care.)
Timepoint [9] 402622 0
6 weeks, 3 and 12 months post-intervention commencement
Secondary outcome [10] 402624 0
Telehealth Usability Questionnaire (for ARMS 2 and 3). Assesses the usefulness, ease, quality, reliability and satisfaction with telehealth use.
Timepoint [10] 402624 0
6 weeks and 3 months post-intervention commencement
Secondary outcome [11] 402625 0
Healthcare use: Participants will be asked to answer yes or no to whether they have used any health services or co-interventions over the last 6 weeks. If they answer yes there will be follow-up questions about health professional services they had and how many, medications they used (what type and how many) and any other treatments
Timepoint [11] 402625 0
6, 12, 18, 26, 32, 38, 44, 52 weeks post-intervention commencement
Secondary outcome [12] 402626 0
Self-reported exercise adherence (frequency). This will be assessed by asking patients the average number of weekly exercise sessions they completed over the last 6 weeks.
Timepoint [12] 402626 0
6 weeks and 3 months post-intervention commencement
Secondary outcome [13] 402627 0
Productivity (including absenteeism and presentism) will be measured using the ‘iMTA Productivity Cost Questionnaire’
Timepoint [13] 402627 0
6, 12, 18, 26, 32, 38, 44, 52 weeks post-intervention commencement
Secondary outcome [14] 402628 0
Adverse events. 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). Participants will be asked how many adverse events they had over the last 6 weeks, how long each lasted for, and to describe the adverse event and any treatment they had for it in open text responses.
Timepoint [14] 402628 0
6, 12, 18, 26, 32, 38, 44, 52 weeks post-intervention commencement
Secondary outcome [15] 403350 0
Self-reported exercise adherence (intensity). This will be assessed by asking patients the average intensity of exercise during their exercise sessions (on the OMNI scale) over the last 6 weeks.
Timepoint [15] 403350 0
6 weeks and 3 months post-intervention commencement

Eligibility
Key inclusion criteria
Inclusion criteria will include;
• age of 18 years and above;
• shoulder pain for > 6 weeks on one or both sides;
• pain is attributable to rotator cuff related shoulder pain based on the diagnostic criteria set out in the British Elbow and Shoulder Society (BESS) guidelines;
• not currently receiving physiotherapy treatment;
• able to understand spoken and written English.
• minimum shoulder pain and disability index (SPADI) score of 30.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria will include (note, these apply to the most painful shoulder side if both sides are symptomatic);
• History of significant trauma (i.e. dislocation, fracture)
• History of shoulder surgery
• Neurological disorder affecting the shoulder
• Other shoulder pathology (i.e. frozen shoulder, inflammatory arthritis, GHJ instability)
• Suspicion of red flags based on the BESS criteria
• They have received a steroid injection in the last 3 months

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)
Once a group of nine is screened and deemed eligible, they will complete baseline assessment and then be randomised by this independent researcher (3 randomised into each treatment arm). They will then be allocated to a treatment as soon as possible. There may be a delay of up to a week for group 2/3 participants (until we determine their preference for times and also allocate a physiotherapist).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Eligible participants will be randomly assigned to one of the three treatment arms using computer generated blocks of nine. This process will be undertaken remotely by an independent researcher to ensure allocation concealment. This researcher will have not contact with the participants or researchers who are screening participants.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Between group differences in outcomes will be compared at 6 weeks, 12 weeks and 12-months (intention-to-treat principles). Continuously scored outcome measures for each time point will be analysed jointly using linear mixed models with adjustments for covariates including baseline scores, treatment group and time. Random intercepts will be included in the model at the physiotherapist level and we will investigate interaction terms. Ordinal scaled data will be analysed using non-parametric tests and modelled with proportional odds regression adjusted for repeated assessment of subjects. Dichotomous scaled outcome measures will be compared using relative risk, risk difference, and number needed to treat (NNT) using generalised estimating equations. Sensitivity to missing data will be assessed using multiple imputation models incorporating predictive baseline and post-baseline variables. Assumptions of models will be assessed using standard diagnostic plots and methods.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/02/2022
Actual
14/02/2022
Date of last participant enrolment
Anticipated
20/03/2023
Actual
20/03/2023
Date of last data collection
Anticipated
20/03/2024
Actual
21/03/2023
Sample size
Target
333
Accrual to date
Final
346
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310067 0
Commercial sector/Industry
Name [1] 310067 0
HCF
Country [1] 310067 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Wellington Rd, Clayton VIC 3800
Country
Australia
Secondary sponsor category [1] 311126 0
None
Name [1] 311126 0
Address [1] 311126 0
Country [1] 311126 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309759 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 309759 0
Ethics committee country [1] 309759 0
Australia
Date submitted for ethics approval [1] 309759 0
09/09/2021
Approval date [1] 309759 0
02/11/2021
Ethics approval number [1] 309759 0
29486

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

Contacts
Principal investigator
Name 115290 0
A/Prof Peter Malliaras
Address 115290 0
Department of Physiotherapy, Monash University, Peninsula Campus, Moorooduc Hwy, Frankston VIC 3199
Country 115290 0
Australia
Phone 115290 0
+61 0400206480
Fax 115290 0
Email 115290 0
[email protected]
Contact person for public queries
Name 115291 0
Peter Malliaras
Address 115291 0
Department of Physiotherapy, Monash University, Peninsula Campus, Moorooduc Hwy, Frankston VIC 3199
Country 115291 0
Australia
Phone 115291 0
+61 0400206480
Fax 115291 0
Email 115291 0
[email protected]
Contact person for scientific queries
Name 115292 0
Peter Malliaras
Address 115292 0
Department of Physiotherapy, Monash University, Peninsula Campus, Moorooduc Hwy, Frankston VIC 3199
Country 115292 0
Australia
Phone 115292 0
+61 0400206480
Fax 115292 0
Email 115292 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?
Anonymised outcome data (all of the individual participant data collected during the trial) will be shared upon request from other researchers/systematic reviewers
When will data be available (start and end dates)?
After completion of the trial and data analysis in 2023. No end date.
Available to whom?
Researchers and systematic reviewers
Available for what types of analyses?
Systematic reviews and meta-analyses
How or where can data be obtained?
By contacting the contact person: Peter Malliaras. [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.