PRIME: PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment
Study Details
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 meniscal tears, after a physical therapy treatment based on therapeutic exercise and education.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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].
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Therapeutic exercise plus education The treatment will consist of a progressive resistance exercise program along with education. |
Other: Therapeutic resistance exercise
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.
Other: Education
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.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 Outcome Measures
- 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).
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Hospital Universitario Fundación Alcorcón
- 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
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 23/67