NCT05770908CompletedNot Applicable
Web Application Based on Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
Hospital Universitario Fundación Alcorcón2 sites in 1 country154 target enrollmentStarted: April 7, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 154
- Locations
- 2
- Primary Endpoint
- Change in Shoulder Pain and Disability Index (SPADI)
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The investigators involved in the recruitment, and data analysis will be masked of participant's allocation group.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Irene Pérez Porta
Principal Investigator
Hospital Universitario Fundación Alcorcón
Study Sites (2)
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