Clinical trial NCT05770908: Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain
Official title: Web Application Based on Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Impingement Syndrome
Rotator Cuff Tendinitis
Rotator Cuff Related Shoulder Pain
Keywords: Rotator Cuff Related Shoulder Pain
Therapeutic Exercise
Web-based video
Lead sponsor: Hospital Universitario Fundación Alcorcón
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: European Union
First posted: 2023-03-16
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in Shoulder Pain and Disability Index (SPADI)
timeFrame: Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week
Secondary outcomes:
measure: Change in Pain intensity
timeFrame: Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week
measure: Change in Patient's expectations of improvement
timeFrame: Change from baseline to 3-week, and change from baseline to 6-week
measure: Patient's satisfaction
timeFrame: 6-week, and 12-week
measure: Patient's impression of improvement
timeFrame: 6-week, 12-week, and 24-week
measure: Patient's perceived usability of multimedia animations
timeFrame: 12-week
measure: Patient's perceived usefulness of multimedia animations
timeFrame: 12-week
measure: Patient's satisfaction with the multimedia animations
timeFrame: 12-week
measure: Patient's adherence
timeFrame: 3-week, 6-week, 12-week, and 24-week
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundacion Alcorcon
state: Madrid
Study officials:
References: