Web Application Based on Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial

Hospital Universitario Fundación Alcorcón1 site in 1 country154 target enrollmentApril 7, 2023

ConditionsRotator Cuff Impingement Syndrome Rotator Cuff Tendinitis Rotator Cuff Related Shoulder Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rotator Cuff Impingement Syndrome
Sponsor: Hospital Universitario Fundación Alcorcón
Enrollment: 154
Locations: 1
Primary Endpoint: Change in Shoulder Pain and Disability Index (SPADI)
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of this randomized controlled trial is to evaluate the benefits from adding multimedia animations to a paper-based therapeutic exercise program in subjects with rotator cuff related shoulder pain. The main question[s] it aims to answer are:

Does subjects improve more regarding shoulder disability and pain?
Are the subjects more satisfied with the treatment received?
Do the subjects adhere more to the exercise program?
Do the subjects have greater expectations with the treatment received? Participants will perform a therapeutic exercise program within 6 months. Researchers will compare the addition of web-app animations to the classical paper-based information.

Registry

clinicaltrials.gov

Start Date

April 7, 2023

End Date

December 1, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hospital Universitario Fundación Alcorcón

Responsible Party

Principal Investigator

Irene Pérez Porta

Principal Investigator

Hospital Universitario Fundación Alcorcón

Eligibility Criteria

Inclusion Criteria

•Presence of rotator cuff related shoulder pain, diagnosed as unilateral shoulder pain, located in the anterior and/or lateral deltoid region, which is reproduced by active elevation and/or lying on ipsilateral side, and with at least one the following orthopaedic tests: Neer, Hawkins-Kennedy and/or empty can.
•Pain lasting from at least 3-months.
•Pain intensity at rest, during movement, and sleeping ≥ 3/10 points on a numeric pain rating scale.
•To have a mobile phone, tablet or computer with internet connection.
•To understand written and spoken Spanish language.

Exclusion Criteria

•History of major trauma or surgery on the shoulder, elbow, or cervical spine.
•Signs of other shoulder pathologies such as instability, frozen shoulder, calcific tendonitis, severe arthrosis, or neuralgic amyotrophy.
•Presence of full-thickness rotator cuff tears on ultrasound imaging.
•Signs and/or symptoms of neck-related shoulder pain and/or radiculopathy or radicular pain.
•Systemic diseases such as cancer, rheumatic disorders, sclerosis multiple, neurological disorders, etc.
•Severe psychiatric disorders.

Outcomes

Primary Outcomes

Change in Shoulder Pain and Disability Index (SPADI)

Time Frame: Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week

The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)

Secondary Outcomes

Change in Patient's expectations of improvement(Change from baseline to 3-week, and change from baseline to 6-week)
Patient's satisfaction(6-week, and 12-week)
Patient's perceived usefulness of multimedia animations(12-week)
Patient's adherence(3-week, 6-week, 12-week, and 24-week)
Change in Pain intensity(Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week)
Patient's perceived usability of multimedia animations(12-week)
Patient's satisfaction with the multimedia animations(12-week)
Patient's impression of improvement(6-week, 12-week, and 24-week)