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

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

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.

Study Overview

• Status: Suspended
• Conditions: Rotator Cuff Injuries
• Intervention / Treatment: Other: Education; Other: Therapeutic resistance exercise

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 Type: Interventional
• Enrollment (Estimated): 386
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Univeristario Fundación Alcorcón

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Therapeutic exercise plus education; The treatment will consist of a progressive resistance exercise program along with education.

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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder disability	Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability).	Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for surgery	Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).	3-month, 6-month, and 1-year.
Shoulder pain intensity	Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).	Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's expectations	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).	Baseline
Pain catastrophizing	Pain catastrophizing measured with the Pain Catastrophizing Scale, which ranges from 0 (minimum degree of catastrophizing) to 100 (maximum degree of catastrophizing).	Baseline

Collaborators and Investigators

• Sponsor: Hospital Universitario Fundación Alcorcón
• Collaborators: Hospital General Universitario Gregorio Marañon; Hospital Universitario Ramon y Cajal; Hospital Universitario La Paz; Hospital Universitario de Fuenlabrada; Hospital Universitario Principe de Asturias; Hospital Universitario La Princesa; Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026

Study Registration Dates

• First Submitted: June 9, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 25, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Exercise; Physical therapy; Education; Prediction model; Rotator cuff; Full-thickness tear
• Additional Relevant MeSH Terms: Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: 23/66

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD data will be shared with other researcher upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No