Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

Study Overview
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Brief Summary
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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 perform better the trained exercises? 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.

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

Conditions
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Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Related Shoulder Pain

Intervention / Treatment
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* Other: Therapeutic exercise program
* Other: Multimedia animation information
* Other: Paper-based information


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multimedia animation videos plus paper-based therapeutic exercise program<br> | Other: Therapeutic exercise program<br>* Therapeutic exercise program based on increasing resistance with elastic bands or weights. The programmes are composed of combinations of the following exercises: Scaption with elastic band. External rotation at 0º of abduction with elastic band. Internal rotation at 0º of abduction with elastic band. Shoulder protraction in supine position with weights. Low row with elastic band. Horizontal adduction stretching.<br>Other: Multimedia animation information<br>* Multimedia animation videos (including audio) showing the performance of the prescribed exercises.<br>Other: Paper-based information<br>* Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance.<br>|
| Active Comparator: Paper-based therapeutic exercise program<br> | Other: Therapeutic exercise program<br>* Therapeutic exercise program based on increasing resistance with elastic bands or weights. The programmes are composed of combinations of the following exercises: Scaption with elastic band. External rotation at 0º of abduction with elastic band. Internal rotation at 0º of abduction with elastic band. Shoulder protraction in supine position with weights. Low row with elastic band. Horizontal adduction stretching.<br>Other: Paper-based information<br>* Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Shoulder Pain and Disability Index (SPADI) | The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability) | Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain intensity | 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). | Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week | 
| Change in Patient's expectations of improvement | Patient's expectations of improvement measured with a numeric rating scale, which ranges from 0 (no expectation of improvement) to 10 (full recovery expectation). | Change from baseline to 3-week, and change from baseline to 6-week | 
| Patient's satisfaction | 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) | 6-week | 
| Patient's satisfaction | 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) | 12-week | 
| Patient's impression of improvement | 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). | 6-week | 
| Patient's impression of improvement | 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). | 12-week | 
| Patient's impression of improvement | 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). | 24-week | 
| Patient's ability to adequately perform the prescribed exercises | Patient's ability to adequately perform the prescribed exercises will be evaluated only in 20 subjects (ten from each group). It will be measured recording videotapes of the patient's performing the exercises, that will be rated by two independent investigators as good/bad performance, five times per exercise (three exercises overall). | 6-week | 
| Patient's adherence | 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. | 3-week | 
| Patient's adherence | 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. | 6-week | 
| Patient's adherence | 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. | 12-week | 
| Patient's adherence | 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. | 24-week | 
| Patient's satisfaction with the multimedia animations | 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). | 12-week | 
| Patient's perceived usability of multimedia animations | 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. | 12-week | 
| Patient's perceived usefulness of multimedia animations | 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). | 12-week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotator Cuff Related Shoulder Pain, Therapeutic Exercise, Web-based video