PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment

NCT ID: NCT05909865

Last Updated: 2025-05-25

Study Results

Results pending

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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Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

386 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-01

Study Completion Date

2025-05-20

Brief Summary

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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

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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) \[Linear relationship\].

Conditions

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Meniscus Tear

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Therapeutic exercise plus education

The treatment will consist of a progressive resistance exercise program along with education.

Group Type EXPERIMENTAL

Therapeutic resistance exercise

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario La Paz

OTHER

Sponsor Role collaborator

Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role collaborator

Hospital Universitario La Princesa

UNKNOWN

Sponsor Role collaborator

Hospital General Universitario Gregorio Marañon

OTHER

Sponsor Role collaborator

Hospital Universitario Principe de Asturias

OTHER

Sponsor Role collaborator

Hospital Universitario de Fuenlabrada

OTHER

Sponsor Role collaborator

Hospital Universitario Infanta Leonor - Vallecas/H. Virgen de la Torre

UNKNOWN

Sponsor Role collaborator

Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role lead

Responsible Party

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Rubén Fernández Matías

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Fundación Alcorcón

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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23/67

Identifier Type: -

Identifier Source: org_study_id

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