Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment

Not Applicable

Suspended

• Conditions: Rotator Cuff Injuries

• Registration Number: NCT05913050
• Lead Sponsor: Hospital Universitario Fundación Alcorcón

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) \[Linear relationship\].

Study Timeline

• Study First Submitted: 2023-06-09
• Study First Submitted QC: 2023-06-16
• Study First Posted: 2023-06-22
• Study Start: 2024-05-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-09-18
• Study Completion: 2026-09-18

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 386

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Hospital Univeristario Fundación Alcorcón; 🇪🇸 Madrid, Spain