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

Primary Purpose

Rotator Cuff Injuries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Therapeutic resistance exercise
Education
Sponsored by
Hospital Universitario Fundación Alcorcón
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rotator Cuff Injuries focused on measuring Physical therapy, Rotator cuff, Full-thickness tear, Exercise, Education, Prediction model

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Therapeutic exercise plus education

    Arm Description

    The treatment will consist of a progressive resistance exercise program along with education.

    Outcomes

    Primary Outcome Measures

    Shoulder disability
    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

    Shoulder pain intensity
    Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).
    Need for surgery
    Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).

    Full Information

    First Posted
    June 9, 2023
    Last Updated
    October 13, 2023
    Sponsor
    Hospital Universitario Fundación Alcorcón
    Collaborators
    Hospital Universitario de Fuenlabrada, Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Hospital Universitario La Princesa, Hospital General Universitario Gregorio Marañon, Hospital Universitario Principe de Asturias
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05913050
    Brief Title
    Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment
    Acronym
    PROTO
    Official Title
    Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment (the PROTO Study): a Multivariable Prediction Model Development Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 18, 2023 (Anticipated)
    Primary Completion Date
    September 18, 2026 (Anticipated)
    Study Completion Date
    September 18, 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hospital Universitario Fundación Alcorcón
    Collaborators
    Hospital Universitario de Fuenlabrada, Hospital Universitario Infanta Leonor - Vallecas / Hospital Virgen de la Torre, Hospital Universitario La Paz, Hospital Universitario Ramon y Cajal, Hospital Universitario La Princesa, Hospital General Universitario Gregorio Marañon, Hospital Universitario Principe de Asturias

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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].

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rotator Cuff Injuries
    Keywords
    Physical therapy, Rotator cuff, Full-thickness tear, Exercise, Education, Prediction model

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    386 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapeutic exercise plus education
    Arm Type
    Experimental
    Arm Description
    The treatment will consist of a progressive resistance exercise program along with education.
    Intervention Type
    Other
    Intervention Name(s)
    Therapeutic resistance exercise
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Education
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Shoulder disability
    Description
    Shoulder disability measured with the Shoulder Pain and Disability Index, which ranges from 0 (no disability) to 100 (maximum degree of disability).
    Time Frame
    Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
    Secondary Outcome Measure Information:
    Title
    Shoulder pain intensity
    Description
    Shoulder pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).
    Time Frame
    Change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
    Title
    Need for surgery
    Description
    Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).
    Time Frame
    3-month, 6-month, and 1-year.
    Other Pre-specified Outcome Measures:
    Title
    Pain catastrophizing
    Description
    Pain catastrophizing measured with the Pain Catastrophizing Scale, which ranges from 0 (minimum degree of catastrophizing) to 100 (maximum degree of catastrophizing).
    Time Frame
    Baseline
    Title
    Patient's expectations
    Description
    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).
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rubén Fernández Matías, MSc
    Phone
    916219727
    Email
    ruben.fernanmat@gmail.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    IPD data will be shared with other researcher upon reasonable request.

    Learn more about this trial

    Predicting ROtator Cuff Tears Outcomes After Physical Therapy Treatment

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