Skip to content

Telerehabilitation and internet-based management of rotator cuff related pain: a pilot and feasibility randomised controlled trial

Telerehabilitation and internet-based management of rotator cuff related pain: a pilot and feasibility randomised controlled trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000248965
Enrollment
36
Registered
2020-02-26
Start date
2020-03-16
Completion date
2020-03-30
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 related pain directly about their condition and recommended care has the potential to reduce inappropriate 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 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.

Interventions

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, o

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.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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).

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026