Clinical trial NCT05913050: Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment
Official title: Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment (the PROTO Study): a Multivariable Prediction Model Development Study
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Rotator Cuff Injuries
Keywords: Physical therapy
Rotator cuff
Full-thickness tear
Exercise
Education
Prediction model
Lead sponsor: Hospital Universitario Fundación Alcorcón
Sponsor class: OTHER
Collaborators: name: Hospital Universitario de Fuenlabrada
name: Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre
name: Hospital Universitario La Paz
name: Hospital Universitario Ramon y Cajal
name: Hospital Universitario La Princesa
name: Hospital General Universitario Gregorio Marañon
name: Hospital Universitario Principe de Asturias
First posted: 2023-06-22
Enrollment: 386
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study will be a non-controlled multicenter clinical trial with the main aim of developing a multivariable prediction model of the improvements after a physical therapy treatment based on exercise and education.
Primary purpose: TREATMENT

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) \[Linear relationship\].

Eligibility criteria: 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.

Primary outcomes:
measure: Shoulder disability
timeFrame: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Secondary outcomes:
measure: Shoulder pain intensity
timeFrame: Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
measure: Need for surgery
timeFrame: 3-month, 6-month, and 1-year.
Other outcomes:
measure: Pain catastrophizing
timeFrame: Baseline
measure: Patient's expectations
timeFrame: Baseline
Locations:
city: Madrid
country: Spain
facility: Hospital Univeristario Fundación Alcorcón
Study officials:
References: