Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement - Single-center, Pragmatic, Randomized, Assessor Blinded, Pilot Study-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline in Korean version of Western Ontario and McMaster Universities Arthritis Index
研究概览
简要总结
Efficacy and Safety of Acupuncture Treatment as an Adjunctive Therapy After Knee Replacement
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
single blinded, outcome assessor blinded
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a diagnosis of osteoarthritis and listed for an unilateral total knee replacement.
- •Subject has a normal cognitive function
- •Subject is willing and able to give informed consent for participation in the study.
排除标准
- •Those who have undergone total knee arthroplasty due to gout
- •Those who have had total knee arthroplasty due to trauma
- •Those who have had total knee arthroplasty due to autoimmune related diseases such as rheumatoid arthritis
- •Those who are participating in other clinical trials
- •Those who have a history of participating in other clinical trials within one month
- •Those who are difficult to write a research consent form
- •Those who are judged to be inappropriate for the clinical study by the researchers.
研究组 & 干预措施
Acupuncture + Usual care
Acupuncture with Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet
干预措施: Acupuncture and Usual care (Other)
Usual care
Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet
干预措施: Usual care (Drug)
结局指标
主要结局
Change from baseline in Korean version of Western Ontario and McMaster Universities Arthritis Index
时间窗: Screening, day 11, day 21
K-WOMAC is widely used in the evaluation of Hip and Knee Osteoarthritis. It is a self-administered questionnaire consisting of 24 items divided into 3 subscales
次要结局
- Change from baseline in Physical Condition related with mobility at every visit(Screening, day 11, day 84)
- Change from baseline in Timed Up and Go Test at every visit(Screening, day 11, day 84)
- Change from baseline in Alternative-Step Test at every visit(Screening, day 11, day 84)
- Change from baseline in Range of motion(Screening, baseline, day 5, 11, 28, 84)
- Change from baseline in Physical Condition related with endurance at every visit(Screening, day 11, day 84)
- Change from baseline in Numeric rating scale(Screening, baseline, day 5, 11, 21, 28, 84)
研究者
Yun-Kyung Song
Sponsor-principle investigator
Gachon University Gil Oriental Medical Hospital