Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain
- Conditions
- Rotator Cuff Impingement SyndromeRotator Cuff TendinitisRotator Cuff Related Shoulder Pain
- Registration Number
- NCT05770908
- Lead Sponsor
- Hospital Universitario Fundación Alcorcón
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 154
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in Shoulder Pain and Disability Index (SPADI) 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 Outcome Measures
Name Time Method Change in Patient's expectations of improvement Change from baseline to 3-week, and change from baseline to 6-week Patient's expectations of improvement measured with a numeric rating scale, which ranges from 0 (no expectation of improvement) to 10 (full recovery expectation).
Patient's satisfaction 6-week, and 12-week Patient's satisfaction with received treatment measured with a numeric rating scale, which ranges from zero (not at all satisfied with the treatment received) to 10 (fully satisfied with the treatment received)
Patient's perceived usefulness of multimedia animations 12-week Patient's perceived usefulness of multimedia animations measured with a 5-point Likert-type scale, which ranges from 1 (strongly disagree) to 5 (strongly agree).
Patient's adherence 3-week, 6-week, 12-week, and 24-week Patient's home adherence to the prescribed exercises measured with self-registered calendars, as the percentage of days performing the exercise at home over the maximum days available between the first physical therapy session and the last follow-up.
Change in Pain intensity Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week Mean pain intensity during last week (at rest, with movement, and at night) measured with a numeric pain rating scale, which ranges from zero (no pain) to 10 (worst pain imaginable).
Patient's perceived usability of multimedia animations 12-week Patient's perceptions on the usability of the multimedia animations measured with the System Usability Scale (SUS), which is composed of 10 items that are rated in a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree), with an overall rating ranging from 0% of perceived usability to 100% of perceived usability.
Patient's satisfaction with the multimedia animations 12-week Patient's satisfaction with the multimedia animations measured with a 5-point Likert-type scale, which ranges from 1 (strongly disagree) to 5 (strongly agree).
Patient's impression of improvement 6-week, 12-week, and 24-week Patient's impression of improvement measured with the Patient Global Impression of Improvement (PGI-I) scale. The PGI-I is an seven-point ordinal scale ranging from 1 (much worse), through 3 (no change), to 6 (very much better).
Trial Locations
- Locations (1)
Hospital Universitario Fundacion Alcorcon
🇪🇸Alcorcón, Madrid, Spain
Hospital Universitario Fundacion Alcorcon🇪🇸Alcorcón, Madrid, Spain