Digitally Delivered Exercise and Education Treatment for Shoulder Pain: 3 Months Follow-up

Completed

• Conditions: Subacromial Pain Syndrome; Shoulder Pain

• Registration Number: NCT05402514
• Lead Sponsor: Joint Academy

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-10-05
• Study First Submitted: 2022-05-30
• Study First Submitted QC: 2022-05-30
• Study First Posted: 2022-06-02
• Primary Completion: 2022-06-24
• Study Completion: 2022-06-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-20
• Last Update Posted: 2023-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 682

Inclusion Criteria

• Subacute or long term subacromial pain

Exclusion Criteria

• acute pain caused by trauma within the past 3 months that has not yet been physically examined
• signs of acute infection
• suspected undiagnosed malignancy
• radiculopathy from the neck
• shortness of breath or chest pain combined with shoulder pain

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Numeric Rating Scale (NRS)	Weekly changes and baseline to 3 month follow-up	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.

Secondary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	Baseline and follow-up after 3 months	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.

Trial Locations

Locations (1)

Joint Academy; 🇸🇪 Malmö, Skåne, Sweden