PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment (PRIME)

Hospital Universitario Fundación Alcorcón

Status

Suspended

Conditions

Meniscus Tear

Treatments

Other: Education

Other: Therapeutic resistance exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT05909865

23/67

Details and patient eligibility

About

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.

Full 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].

Enrollment

386 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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.