Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment

Rotator Cuff Injuries Clinical Trial

— PROTO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05913050
• Other study ID #: 23/66
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 18, 2026

Study information

• Verified date: May 2024
• Source: Hospital Universitario Fundación Alcorcón
• Contact: Rubén Fernández Matías, MSc
• Phone: 916219727
• Email: ruben.fernanmat[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 386
• Est. completion date: September 18, 2026
• Est. primary completion date: September 18, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Univeristario Fundación Alcorcón	Madrid

Sponsors (8)

Lead Sponsor	Collaborator
Hospital Universitario Fundación Alcorcón	Hospital General Universitario Gregorio Marañon, Hospital Universitario de Fuenlabrada, Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre, Hospital Universitario La Paz, Hospital Universitario La Princesa, Hospital Universitario Principe de Asturias, Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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.
Secondary	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.