PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment

Study Overview
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Brief Summary
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The aim of this multicenter non-controlled study is to develop a multivariable prediction model of pain/disability improvements in patients with meniscal tears, after a physical therapy treatment based on therapeutic exercise and education.

Detailed Description
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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 Knee Injury and Ostoarthritis Outcome Score) [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].

Official Title
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PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment (the PRIME Study): a Multivariable Prediction Model Development Study

Conditions
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Meniscus Tear

Intervention / Treatment
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* Other: Therapeutic resistance exercise
* Other: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Degenerative meniscal tears (medial and/or lateral), diagnosed by magnetic resonance imaging. Traumatic meniscal tears (medial and/or lateral), diagnosed by magnetic resonance imaging, originated 6 months ago or more. Pain intensity equal or greater to 3 points in a numeric pain rating scale, or a degree of disability in the KOOS questionnaire greater or equal to 15%. Pain lasting 3 months ore more. Adequate comprehension of written and spoken Spanish Exclusion Criteria: Knee ligament injuries at the moment of recruitment. Presence of hip or ankle pathology that makes it impossible to peform knee therapeutic exercises. History of fracture in the lower limb within the last year. History of surgery in the lower lim within the last year. Presence of cancer, fibromyalgia, neurological and/or other systemic diseases. Cognitive impairment that makes it impossible to perform therapeutic exercise.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic exercise plus education<br>The treatment will consist of a progressive resistance exercise program along with education. | Other: Therapeutic resistance exercise<br>* 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.<br>Other: Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee disability | Knee disability measured with the Knee Injury and Osteoarthritis Outcome Score, which ranges from 0 (no disability) to 100 (maximum degree of disability). | Baseline, 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 |
| --- | --- | --- |
| Knee pain intensity | Knee pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain). | Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Education, Physical therapy, Therapeutic resistance exercise, Prediction model