Home-Based Strategies for Knee Osteoarthritis: Comparative Effectiveness of Exercise and Topical Therapy in a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Numeric Pain Rating Scale (NPRS)
研究概览
简要总结
Knee osteoarthritis (KOA) is a common chronic joint condition leading to pain, functional limitations, and reduced quality of life. This randomized controlled trial aims to evaluate and compare the effectiveness of a structured home-based exercise program versus topical diclofenac sodium therapy in improving pain, functional outcomes, and health-related quality of life among adults with early-stage KOA. The results are intended to provide evidence on the optimal components of home-based conservative management strategies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
single
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 40-70 years
- •Diagnosed with Kellgren-Lawrence grade I-II knee osteoarthritis
- •Ability to provide written informed consent
排除标准
- •Advanced KOA (Kellgren-Lawrence grade IV) requiring arthroplasty
- •Prior knee surgery within the past year
- •Intra-articular injections within the last 3 months
- •Neurological, rheumatological, or systemic conditions affecting mobility
- •Inability to comply with study procedures
研究组 & 干预措施
Home Exercise Group
Each subject in the home exercise group will receive a video-based protocol of exercises for knee osteoarthritis to perform at home.
干预措施: Home Exercise Group (Other)
Topical Therapy Group
Each subject in the topical therapy group will apply topical gel to anterior, medial, and lateral aspects of the knee at home.
干预措施: Topical Therapy Group (Other)
结局指标
主要结局
Numeric Pain Rating Scale (NPRS)
时间窗: Six-week
Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as \>2.
Numeric Pain Rating Scale (NPRS)
时间窗: Baseline
Pain intensity will be measured using an 11-point numeric pain rating scale, with 0 indicating no pain and 10 indicating the worst pain conceivable. Patients will be asked to rate their knee pain's severity with a number between 0 and 10 using this scale. The minimum clinically important difference (MCID) of this validated pain scale is accepted as \>2.
次要结局
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Six-week)
- 12-Item Short Form Survey (SF-12)(Six- week)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Baseline)
- 12-Item Short Form Survey (SF-12)(Baseline)
研究者
Sezen Karaborklu Argut
Dr., assistant professor
Istanbul University - Cerrahpasa