Specific and Non-Specific Effects of Acupuncture: A Double-Blinded, Randomized, Controlled Trial in Patients With Osteoarthritis of the Knee
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 125
- 主要终点
- Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
研究概览
简要总结
The aim of this study was to evalute three different acupuncture techniques, including one sham control, in its effect on osteoarthitis of the knee
详细描述
Background: Acupuncture is one of the most frequently used complementary therapeutic approaches in the treatment of osteoarthritis of the knee. Due to methodological shortcomings of previous randomized controlled studies, controversy persists whether the observed effects are specific to acupuncture or non-specific consequences of needling.
Objective
To compare classical Chinese acupuncture, semi-standardized modern acupuncture and non-specific needling by means of a double-blinded repeated measures cross-over design.
Intervention: Within three weeks all patients receive three treatment modalities in a random order in a double-blind study design.
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above age 35
- •knee osteoarthritis grade II or III according to the Kellgren classification.
排除标准
- •orthopedic deformations of the knee,
- •malignant disease
- •auto-immune disorders
- •surgery including arthroscopy during the past 12 months
- •pain medication with steroids
- •physical therapy or acupuncture within the last for weeks
- •no or a pain medication in continuous dosage
结局指标
主要结局
Main outcome measures: Improvement in knee flexibility according to the neutral-zero method, defining a success as improvement by 10 degrees or more.
次要结局
- Secondary parameter: improvement in pain according to the reduced WOMAC score by 50 percent or more.