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Financial support for the project has been discontinued.
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| Name | Class |
|---|---|
| Hospital Universitario de Fuenlabrada | OTHER |
| Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre | UNKNOWN |
| Hospital Universitario La Paz | OTHER |
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The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with full-thickness rotator cuff tears, after a physical therapy treatment based on therapeutic exercise and education.
A multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic exercise plus education | Experimental | The treatment will consist of a progressive resistance exercise program along with education. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic resistance exercise | Other | Therapeutic exercise program based on individualized progressive resistance exercises performed during 3 months at home, with a frequency of 1-3 sessions per week at the hospital. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder disability | Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability). | Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. |
| Measure | Description | Time Frame |
|---|---|---|
| Shoulder pain intensity | Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain). | Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. |
| Need for surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain catastrophizing | Pain catastrophizing measured with the Pain Catastrophizing Scale, which ranges from 0 (minimum degree of catastrophizing) to 100 (maximum degree of catastrophizing). | Baseline |
| Patient's expectations |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Univeristario Fundación Alcorcón | Madrid | Spain |
IPD data will be shared with other researcher upon reasonable request.
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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| Hospital Universitario Ramon y Cajal |
| OTHER |
| Hospital Universitario La Princesa | UNKNOWN |
| Hospital General Universitario Gregorio Marañon | OTHER |
| Hospital Universitario Principe de Asturias | OTHER |
The study will be a non-controlled multicenter clinical trial with the main aim of developing a multivariable prediction model of the improvements after a physical therapy treatment based on exercise and education.
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| Education | Other | Education applied during all the therapeutic process, focusing on diverting the patient's attention away from the structural lesion, explaining the relationship between pain/disability and tissue injury, explaining the meaning of pain during exercises, and explaining the objectives of the implemented treatments. |
|
Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO). |
| 3-month, 6-month, and 1-year. |
Patient's expectations of improvement with therapeutic exercise measured with the Musculoskeletal Outcomes Data Evaluation and Management System, which ranges from 0 (minimum degree of expectations) to 100 (maximum degree of expectations).
| Baseline |
| D001519 |
| Behavior |