None listed
Conditions
Brief summary
Shoulder pain affects 15-27% of adults and is the 3rd most common musculoskeletal complaint seen by general practitioners in Australia. Rotator cuff (RC) tendinopathy is the most common cause of shoulder pain and people affected have impairments in work and self-care activities, with 40% having ongoing disability beyond 12 months. Clinical practice guidelines and consensus statements suggest 12 weeks of first line management (activity modification, medication advice, clinician guided exercise) for RC tendinopathy prior to considering imaging or surgical referral. In contrast, our team and others have shown high rates of non-guideline indicated (‘low-value’) imaging (up to 80%) and surgical referral (about 20%). Video conferencing-delivered care is cost effective, convenient, and able to reach people in rural and remote regions. However, video conferencing rely on synchronous contact with a health professional, which is both time and labour intensive, and costly. Providing first line care directly to patients in their homes is now possible via digital voice assistant (DVA) or voice-controlled intelligent personal assistants (VIPAs) like Amazon Alexa (“Alexa”). Our group pioneered this technology for delivering exercise interventions for elderly people. We have now developed an Alexa program that delivers high-quality first-line exercise and education to people with RC tendinopathy. Our program includes behaviour change strategies as well as asynchronous interaction with a health professional via the user’s voice responses. The proposed study aims to test the feasibility of a randomized trial comparing DVA care (via Alexa) to telehealth (via Zoom video conferencing) and active control. If successful, this will lead to a full-scale randomized trial in Australian primary care that has the potential to develop evidence for a high quality and efficient internet-delivered intervention that could benefit millions of Australians who suffer with shoulder pain.
Interventions
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
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).
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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?
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?
Outcome results
None listed