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

November 20, 2023 updated by: Joint Academy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

682

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Malmö, Skåne, Sweden
        • Joint Academy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Numeric Rating Scale (NRS)
Time Frame: 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.
Weekly changes and baseline to 3 month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Pain and Disability Index (SPADI)
Time Frame: 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.
Baseline and follow-up after 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joint Academy

Collaborators

Lund University

Investigators

  • Study Director: Leif E Dahlberg, Professor, Arthro Therapeutics /Joint Academy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2021

Primary Completion (Actual)

June 24, 2022

Study Completion (Actual)

June 24, 2022

Study Registration Dates

First Submitted

May 30, 2022

First Submitted That Met QC Criteria

May 30, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Shoulder3months

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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