Meniscus Tear
Conditions
Keywords
Physical therapy, Therapeutic resistance exercise, Education, Prediction model
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) \[Linear relationship\].
Interventions
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.
OTHEREducation
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.
Sponsors
Hospital Universitario La Paz
Hospital Universitario Ramon y Cajal
Hospital Universitario La Princesa
Hospital General Universitario Gregorio Marañon
Hospital Universitario Principe de Asturias
Hospital Universitario de Fuenlabrada
Hospital Universitario Infanta Leonor - Vallecas/H. Virgen de la Torre
Hospital Universitario Fundación Alcorcón
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain Catastrophizing | Baseline | Pain catastrophizing measured with the Pain Catastrophizing Scale, which ranges from 0 (minimum degree of catastrophizing) to 100 (maximum degree of catastrophizing). |
| Patient's expectations | Baseline | 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). |
Countries
Spain
Outcome results
None listed