Clinical trial NCT05402514: Digitally Delivered Exercise and Education Treatment for Shoulder Pain: 3 Months Follow-up
Official title: Digitally Delivered Exercise and Education Treatment for Shoulder Pain: 3 Months Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Shoulder Pain
Subacromial Pain Syndrome
Keywords: Shoulder pain
Rehabilitation
Physical Therapy Modalities
Telerehabilitation
Exercise therapy
Patient education as Topic
Lead sponsor: Joint Academy
Sponsor class: INDUSTRY
Collaborators: name: Lund University
First posted: 2022-06-02
Enrollment: 682
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Numeric Rating Scale (NRS)
timeFrame: Weekly changes and baseline to 3 month follow-up
Secondary outcomes:
measure: Shoulder Pain and Disability Index (SPADI)
timeFrame: Baseline and follow-up after 3 months
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Joint Academy
state: Skåne
Study officials:
affiliation: Arthro Therapeutics /Joint Academy
name: Leif E Dahlberg, Professor
role: STUDY_DIRECTOR
References:
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