NCT05909865暂停不适用
PRedIcting MEniscal Tears Outcomes After Physical Therapy Treatment (the PRIME Study): a Multivariable Prediction Model Development Study
Hospital Universitario Fundación Alcorcón1 个研究点 分布在 1 个国家目标入组 386 人开始时间: 2024年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 386
- 试验地点
- 1
- 主要终点
- Knee disability
研究概览
简要总结
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.
详细描述
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].
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Knee disability
时间窗: Baseline, change from baseline to 3-month, change from baseline to 6-month, and change from baseline to 1-year.
Knee disability measured with the Knee Injury and Osteoarthritis Outcome Score, which ranges from 0 (no disability) to 100 (maximum degree of disability).
次要结局
- 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.)
研究者
Rubén Fernández Matías
Principal Investigator
Hospital Universitario Fundación Alcorcón
研究点 (1)
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