An observational study in Shoulder Pain and Subacromial Pain Syndrome, sponsored by Joint Academy. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-21.
Sponsored by Joint Academy · Observational
The overall aim of this project is to describe changes in pain and perceived shoulder dysfunction in patients with subacromial shoulder pain, following 3 months of digitally delivered first-line treatment containing exercise and patient education with support of a licensed physical therapist.
The intervention, a digital first-line treatment for subacromial shoulder pain is a part of the public healthcare system in Sweden and all residents in the country can access the treatment. The treatment program is based on the existing evidence for treating subacromial shoulder pain and is inspired by specific exercises that have been documented to reduce the need for surgery in the patient group. The program focuses on strengthening the rotator cuff and the muscles stabilizing the scapula. The intervention procedure is similar to previous digital treatments by the same digital care provider and is thoroughly described in previous studies.
Musculoskeletal conditions are identified by the Global Burden of Disease Study as a leading cause of global morbidity. Estimates of the need for rehabilitation services show that at least one in every three people in the world needs rehabilitation at some point in their life course. As disability becomes an increasingly large component of disease burden and health expenditure, greater research and development investment is needed to identify new, more effective intervention strategies.
Traditional face-to-face interventions present barriers, such as limited access and lack of flexibility, which may limit the patients' adherence with the interventions. Digital delivery of the management program may be one way of overcoming such barriers. Telerehabilitation has been successfully implemented and compared to conventional treatments, where adherence to digital treatment has been shown to be associated with an improvement in function and pain in a variety of musculoskeletal(MSK) conditions. The evidence for digital delivered rehabilitation for shoulder pain indicates that it may be a promising way of delivering treatment for the patient group but is still at an early stage and more research is needed.
The overall aim of this project is to describe changes in pain and perceived shoulder dysfunction in patients with subacromial shoulder pain, following 3 months of digitally delivered first-line treatment containing exercise and patient education. A further aim is to compare changes in outcomes between patients with different demographics, and health- and treatment related factors.
The study will be an observational, registry-based longitudinal study with consecutively recruited participants. Socio-demographic data will be collected at baseline including variables such as age, sex, weight, height, highest level of education reached and current job status. All data will be collected through digitally delivered questionnaires in the app at baseline and 3 months besides pain levels, which will be reported weekly until treatment week 6. All outcomes will be self-assessed through the digital program interface. The study will be presented in accordance to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines.
707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.
This study's enrollment of 682 is above the median of 82 across 130 observational studies indexed under Shoulder Pain.
Browse Shoulder Pain studies →Joint Academy is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients eligible for the digital first-line treatment program for subacromial shoulder pain with given informed consent will be included in the study. General marketing through different media channels, the company website and word of mouth will be used to recruit patients for the treatment. Patients will not be required to have a doctor or physical therapist referral to enter the treatment. Patients without a prior diagnosis will be assessed and diagnosed by a physical therapist per phone or video call.
Exclusion Criteria:
Patients excluded from the program will be welcomed back into the treatment after a physical visit if medical professional conclude that they are eligible for physical therapy.
The Joint Academy® (www.jointacademy.com) program for people with subacromial shoulder pain consist of two daily distributed and progressively adaptable exercises there are delivered through the app as videos with subtitles. Patient education is provided 2-3 times per week as short lessons in the app with a quiz following the text to ensure that the information is properly understood by the patients. An individual physical therapist is assigned to each patient with compulsory telephone or video consultations at the start of the treatment, at 6 weeks and at 3 months. An asynchronous chat function with the physical therapist is available during the treatment period as well as a peer support chat.
Pain Numeric Rating Scale (NRS)
Shoulder pain will be assessed using NRS with the instructions "Mark on the scale your average pain from your shoulder in the past week", followed by a 0-10 scale where 0 is described as "No pain" and 10 described as "Unbearable". Higher scores means worse outcome.
Time frame: Weekly changes and baseline to 3 month follow-up
Shoulder Pain and Disability Index (SPADI)
The self administered Shoulder Pain and Disability Index (SPADI) will be collected at baseline and at 3 months to assess shoulder function. The questionnaire contains 13 items and the score is expressed as percentage where 0 is the best score and 100 the worst score. A higher score means more disability.
Time frame: Baseline and follow-up after 3 months
Plan to share: No
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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