Baseline Predictors of Six-Month Clinical Response to Radial Pressure Wave Therapy in Patients With Knee Osteoarthritis: Secondary Analysis of a Randomized Double-Blind Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Achievement of minimal clinically important difference (MCID) in pain intensity measured by the Numerical Pain Rating Scale (NPRS)
研究概览
简要总结
This observational study aims to identify baseline factors that predict clinical response at six months in patients with knee osteoarthritis treated with radial pressure wave therapy (rESWT). The study is a secondary analysis of data obtained from a randomized double-blind clinical trial conducted in 2024 at a tertiary care hospital in Mexico.
Knee osteoarthritis is a common condition that causes pain, stiffness, and reduced physical function. Radial pressure wave therapy is a non-invasive treatment that has shown benefits in improving symptoms; however, not all patients respond equally.
This study will analyze patient characteristics at baseline, such as age, body mass index, pain severity, and functional status, to determine which factors are associated with meaningful improvement in pain and function after treatment. The results may help clinicians better identify which patients are more likely to benefit from this therapy and improve personalized treatment decisions.
详细描述
Background: Knee osteoarthritis (OA) is a leading cause of pain and disability worldwide. It is characterized by progressive joint degeneration, resulting in pain, stiffness, and functional limitations. Radial pressure wave therapy (rESWT) is a non-invasive treatment that has demonstrated effectiveness in reducing pain and improving function in patients with knee OA. However, there is significant variability in patient response, and the factors that predict treatment success are not well established.
Objective: The aim of this study is to identify baseline predictors of clinical response at six months in patients with knee OA treated with rESWT.
Methods: This study is a secondary analysis of a randomized double-blind clinical trial conducted in 2024 at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde". The original trial evaluated the effectiveness of three standardized rESWT protocols in patients with knee OA. The present study is designed as an observational cohort analysis including patients with complete baseline and follow-up data.
Baseline variables include demographic characteristics (age, sex), clinical factors (body mass index, baseline pain intensity, functional status), and radiographic severity. The primary outcome is the achievement of the minimal clinically important difference (MCID) in the WOMAC score at six months. Secondary outcomes include MCID in pain intensity measured by the Numerical Pain Rating Scale (NPRS) and changes in WOMAC and NPRS scores over time.
Statistical analyses will be conducted to identify independent predictors of clinical response and to explore the interaction between baseline characteristics and treatment protocols.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical and radiographic diagnosis of knee osteoarthritis
- •Participation in the original randomized double-blind clinical trial evaluating radial pressure wave therapy (rESWT) in 2024
- •Availability of complete baseline data
- •Availability of follow-up data up to 6 months
排除标准
- •Incomplete baseline or follow-up data
- •Withdrawal from the original trial before completion
- •Missing outcome measurements required for analysis
- •Presence of conditions that could interfere with outcome assessment or data validity
研究组 & 干预措施
Patients with knee osteoarthritis treated with radial pressure wave therapy
Adult patients with clinically and radiographically diagnosed knee osteoarthritis who participated in a randomized double-blind clinical trial evaluating radial pressure wave therapy (rESWT) in 2024. This cohort includes participants with complete baseline and follow-up data up to six months and is used to identify baseline predictors of clinical response.
干预措施: Radial Pressure Wave Therapy (Procedure)
结局指标
主要结局
Achievement of minimal clinically important difference (MCID) in pain intensity measured by the Numerical Pain Rating Scale (NPRS)
时间窗: 6 months after baseline
The proportion of patients achieving the minimal clinically important difference (MCID) in pain intensity measured using the Numerical Pain Rating Scale (NPRS), a validated 0 to 10 scale where higher scores indicate greater pain.
次要结局
- Achievement of minimal clinically important difference (MCID) in pain intensity measured by the Numerical Pain Rating Scale (NPRS)(6 months after baseline)
- Change in WOMAC score over time(Baseline, 2 months, 4 months, and 6 months)
- Change in pain intensity measured by the Numerical Pain Rating Scale (NPRS) over time(Baseline, 2 months, 4 months, and 6 months)
研究者
Armando Tonatiuh Avila Garcia
Chief Department of Physical Medicine and Rehabilitation
Hospital Civil de Guadalajara