NCT05913050

Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment

Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment (the PROTO Study): a Multivariable Prediction Model Development Study

• Status: Suspended
• Phase: N/A
• Study type: Interventional
• Enrollment: 386 (estimated)
• Sponsor: Hospital Universitario Fundación Alcorcón · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Not accepted

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) \[Linear relationship\].

Conditions

• Rotator Cuff Injuries

Interventions

Type	Name	Description
OTHER	Therapeutic resistance exercise	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.
OTHER	Education	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.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-09-18
• Completion: 2026-09-18
• First posted: 2023-06-22
• Last updated: 2025-05-25

Locations

1 site across 1 country: Spain