Rotator Cuff Injuries
Conditions
Keywords
Physical therapy, Rotator cuff, Full-thickness tear, Exercise, Education, Prediction model
Brief summary
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.
Detailed description
A multivariable prediction model for the improvement in shoulder pain and disability will be developed based on the following predictors: * Body mass index \[kg/m2, Fractional polynomials FP2\]. * Smoking \[Years, linear relationship\]. * Employment status \[3 categories\]. * Maximum education degree \[4 categories\]. * Previous performance of physical exercise \[2 categories\]. * Baseline disability (measured with the Shoulder Pain and Disability Index) \[Fractional polynomials FP2\]. * Baseline pain intensity (measured with a numeric pain rating scale) \[Fractional polynomials FP2\]. * Pain duration \[Weeks, linear relationship\] * Pain catastrophizing (measured with the Pain Catastrophizing Scale) \[Linear relationship\]. * Patient's expectations (measured with the Musculoskeletal Outcomes Data Evaluation and Management System) \[Linear relationship\].
Interventions
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.
OTHEREducation
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.
Sponsors
Hospital Universitario de Fuenlabrada
Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre
Hospital Universitario La Paz
Hospital Universitario Ramon y Cajal
Hospital Universitario La Princesa
Hospital General Universitario Gregorio Marañon
Hospital Universitario Principe de Asturias
Hospital Universitario Fundación Alcorcón
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Full-thickness supraspinatus rotator cuff tear diagnosed by ultrasound imaging or magnetic resonance imaging. * Pain during resisted abduction and/or external rotation. * Pain intensity equal or greater to 3 points on a numeric pain rating scale, or a degree of disability equal or greater to 15% on the Shoulder Pain and Disability Index. * Pain lasting for at least 3 months. * Adequate comprehension of written and spoken Spanish
Exclusion criteria
* Loss of passive external rotation at 0º of shoulder abduction equal or greater to 50% compared to contralateral side. * Suspected neck-related shoulder pain. * Suspected visceral-related shoulder pain. * Sings or symptoms of shoulder instability, including dislocations and/or subluxation within the last year. * Humerus and/or scapular fractures within the last year. * Previous rotator cuff repair surgery within the last year. * Presence of cancer, fibromyalgia, neurological and/or other systemic diseases. * Cognitive impairment that makes it impossible to perform therapeutic exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder disability | Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. | Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder pain intensity | Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. | Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain). |
| Need for surgery | 3-month, 6-month, and 1-year. | Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain catastrophizing | Baseline | Pain catastrophizing measured with the Pain Catastrophizing Scale, which ranges from 0 (minimum degree of catastrophizing) to 100 (maximum degree of catastrophizing). |
| Patient's expectations | Baseline | 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). |
Countries
Spain
Outcome results
None listed