Meniscus Tear Clinical Trial
— PRIMEOfficial title:
PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment (the PRIME Study): a Multivariable Prediction Model Development Study
NCT number | NCT05909865 |
Other study ID # | 23/67 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2024 |
Est. completion date | September 18, 2026 |
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.
Status | Recruiting |
Enrollment | 386 |
Est. completion date | September 18, 2026 |
Est. primary completion date | September 18, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario Fundación Alcorcón | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Fundación Alcorcón | Hospital General Universitario Gregorio Marañon, Hospital Universitario de Fuenlabrada, Hospital Universitario Infanta Leonor - Vallecas/H. Virgen de la Torre, Hospital Universitario La Paz, Hospital Universitario La Princesa, Hospital Universitario Principe de Asturias, Hospital Universitario Ramon y Cajal |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain Catastrophizing | Pain catastrophizing measured with the Pain Catastrophizing Scale, which ranges from 0 (minimum degree of catastrophizing) to 100 (maximum degree of catastrophizing). | Baseline | |
Other | Patient's expectations | 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). | Baseline | |
Primary | 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 | Knee pain intensity | Knee pain intensity measured with a numeric pain rating scale, which ranges from 0 (no pain) to 10 (worst imaginable pain). | Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year. | |
Secondary | Need for surgery | Need for surgery for the rotator cuff tear registered as a dichotomous variable (YES/NO). | 3-month, 6-month, and 1-year. |
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