Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Related Shoulder Pain
Conditions
Keywords
Rotator Cuff Related Shoulder Pain, Therapeutic Exercise, Web-based video
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.
Interventions
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.
OTHERMultimedia animation information
Multimedia animation videos (including audio) showing the performance of the prescribed exercises.
OTHERPaper-based information
Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance.
Sponsors
Instituto de Salud Carlos III
European Union
Hospital Universitario Fundación Alcorcón
Study design
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
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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). |
| 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 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 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 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. |
| 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. |
Countries
Spain
Outcome results
None listed