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| Name | Class |
|---|---|
| Instituto de Salud Carlos III | OTHER_GOV |
| European Union | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimedia animation videos plus paper-based therapeutic exercise program | Experimental |
| |
| Paper-based therapeutic exercise program | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic exercise program | Other | Therapeutic exercise program based on increasing resistance with elastic bands or weights. The programmes are composed of combinations of the following exercises:
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Fundacion Alcorcon | Alcorcón | Madrid | 28922 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39038866 | Derived | Perez-Porta I, Florez-Garcia MT, Garcia-Perez F, Fernandez-Matias R, Perez-Manzanero MA, Araujo-Narvaez AM, Urraca-Gesto MA, Fernandez-Lagarejos C, Plaza-Manzano G, Perez-Fernandez E, Velasco-Arribas M. Effects of a web application based on multimedia animations to support therapeutic exercise for rotator cuff-related shoulder pain: protocol for an open-label randomised controlled trial. BMJ Open. 2024 Jul 22;14(7):e085381. doi: 10.1136/bmjopen-2024-085381. |
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The investigators involved in the recruitment, and data analysis will be masked of participant's allocation group.
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| Multimedia animation information | Other | Multimedia animation videos (including audio) showing the performance of the prescribed exercises. |
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| Paper-based information | Other | Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance. |
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| 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, and 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, 12-week, and 24-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 |
| 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 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, 6-week, 12-week, and 24-week |
| ID | Term |
|---|---|
| D019534 | Shoulder Impingement Syndrome |
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070599 | Shoulder Injuries |
| D014947 | Wounds and Injuries |
| D012421 | Rupture |
| D013708 | Tendon Injuries |
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