Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment

Hospital Universitario Fundación Alcorcón386 enrolled

Overview

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: * 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) \[Linear relationship\].

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

386

Conditions

Rotator Cuff Injuries

Interventions

Therapeutic resistance exerciseOTHER

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.

EducationOTHER

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.

Eligibility

Sex: ALLMin age: 30 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Univeristario Fundación Alcorcón

Madrid, Spain

Outcomes

Primary Outcomes

Shoulder disability

Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability).

Time frame: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.

Secondary Outcomes

Shoulder pain intensity

Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).

Time frame: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.

Need for surgery

Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).

Time frame: 3-month, 6-month, and 1-year.

Data from ClinicalTrials.gov

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