PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment
- Conditions
- Meniscus Tear
- Interventions
- Other: Therapeutic resistance exerciseOther: Education
- Registration Number
- NCT05909865
- Lead Sponsor
- Hospital Universitario Fundación Alcorcón
- Brief Summary
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
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) \[Linear relationship\].
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 386
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Therapeutic exercise plus education Education The treatment will consist of a progressive resistance exercise program along with education. Therapeutic exercise plus education Therapeutic resistance exercise The treatment will consist of a progressive resistance exercise program along with education.
- Primary Outcome Measures
Name Time Method Knee disability Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. Knee disability measured with the Knee Injury and Osteoarthritis Outcome Score, which ranges from 0 (no disability) to 100 (maximum degree of disability).
- Secondary Outcome Measures
Name Time Method Knee pain intensity Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. Knee pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain).
Need for surgery 3-month, 6-month, and 1-year. Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO).
Trial Locations
- Locations (1)
Hospital Universitario Fundación Alcorcón
🇪🇸Madrid, Spain