Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment (PROTO)

Hospital Universitario Fundación Alcorcón

Status

Suspended

Conditions

Rotator Cuff Injuries

Treatments

Other: Therapeutic resistance exercise

Other: Education

Study type

Interventional

Funder types

Other

Identifiers

NCT05913050

23/66

Details and patient eligibility

About

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.

Full 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].

Enrollment

386 estimated patients

Sex

All

Ages

30+ years old

Volunteers

No Healthy Volunteers

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.