PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment
NCT ID: NCT05909865
Last Updated: 2025-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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SUSPENDED
NA
386 participants
INTERVENTIONAL
2024-05-01
2025-05-20
Brief Summary
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Detailed Description
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* 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) \[Linear relationship\].
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Therapeutic exercise plus education
The treatment will consist of a progressive resistance exercise program along with education.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
40 Years
ALL
No
Sponsors
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Hospital Universitario La Paz
OTHER
Hospital Universitario Ramon y Cajal
OTHER
Hospital Universitario La Princesa
UNKNOWN
Hospital General Universitario Gregorio Marañon
OTHER
Hospital Universitario Principe de Asturias
OTHER
Hospital Universitario de Fuenlabrada
OTHER
Hospital Universitario Infanta Leonor - Vallecas/H. Virgen de la Torre
UNKNOWN
Hospital Universitario Fundación Alcorcón
OTHER
Responsible Party
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Rubén Fernández Matías
Principal Investigator
Locations
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Hospital Universitario Fundación Alcorcón
Madrid, , Spain
Countries
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Other Identifiers
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23/67
Identifier Type: -
Identifier Source: org_study_id
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