PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment

NCT05909865 | Suspended

• 1 other identifier: 23/67
• Study Type: interventional
• Target: 386
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniscus Tear

Keywords

Physical therapy; Therapeutic resistance exercise; Education; Prediction model

Outcome Measures

Primary Outcomes (1)

• Knee disability

  Knee disability measured with the Knee Injury and Osteoarthritis Outcome Score, which ranges from 0 (no disability) to 100 (maximum degree of disability).

  Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.

Secondary Outcomes (2)

• Knee pain intensity

  Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.

• Need for surgery

  3-month, 6-month, and 1-year.

Other Outcomes (2)

• Pain Catastrophizing

  Baseline

• Patient's expectations

  Baseline

Study Arms (1)

Therapeutic exercise plus education

EXPERIMENTAL

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

Other: Therapeutic resistance exercise; Other: Education

Interventions

Therapeutic resistance exercise 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.

Therapeutic exercise plus education

Education 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.

Therapeutic exercise plus education

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Fundación Alcorcón: lead
• Hospital Universitario La Paz: collaborator
• Hospital Universitario Ramon y Cajal: collaborator
• Hospital Universitario La Princesa: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Hospital Universitario Principe de Asturias: collaborator
• Hospital Universitario de Fuenlabrada: collaborator
• Hospital Universitario Infanta Leonor - Vallecas/H. Virgen de la Torre: collaborator

Study Sites (1)

Hospital Universitario Fundación Alcorcón

Madrid, Spain

Location

MeSH Terms

Interventions

Educational Status

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: May 1, 2024
• Primary Completion: May 20, 2025
• Study Completion: May 20, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)