Clinical Trial to Evaluate and Compare the Efficacy and Safety of Individualized and Standardized Acupuncture for Knee Osteoarthritis Patients: Randomized, Single-blind, Controlled Study
试验速览
- 阶段
- 不适用
- 发起方
- Eun Jung Kim
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- WOMAC (Western Ontario and McMaster Universities) Scale change
研究概览
简要总结
The purpose of this study is to verify the efficacy and safety of acupuncture treatments (Individualized, Standardized acupuncture) for patients with knee osteoarthritis (OA).
详细描述
The investigators targeted the patients with knee OA. After treatment in 4 groups - individualized acupuncture treatment, standardized acupuncture treatment, sham-needle treatment, and waiting groups - the investigators will compare the effects of pain relieving and daily performing improvement. So the investigators will confirm the efficacy of acupuncture, and further the best treatment method. In addition, the investigators are going to evaluate the safety of abnormal reaction during the treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 20 years of age, but below 80 years of age
- •Knee pain from OA in one or both knees in the last 3 months or more
- •Presence of knee OA diagnosed by an orthopedist based on American College of Rheumatology classification criteria
- •Knee pain from OA in one or both knees rated > 4 cm on a 10 cm Visual Analog Scale (VAS)
- •An understanding of the objectives and methods of the clinical trial, and willingness in completing the consent form.
- •Those who are reliable and willing to cooperate in this test, and obey the restrictions for the next 3 months
排除标准
- •Trauma to or surgery on the knee(s) within 6 months prior to enrollment, causing pain or functional problems
- •A history of prolotherapy, injection of hyaluronic acid or cortisone within the last 3 months
- •A physical or laboratory finding indicating infection, presence of an autoimmune disease, or inflammatory arthritis
- •Serious organic disease, and severe dysfunction due to the medical illness (e.g. Arrhythmia, Angina pectoris, Stroke, Asthma, etc.)
- •More severe pain in regions other than the knee joint.
- •When researchers evaluate that it is not appropriate to participate in this clinical test
结局指标
主要结局
WOMAC (Western Ontario and McMaster Universities) Scale change
时间窗: at 2nd(Baseline),8(after 3weeks of treatment),13th(after 6 weeks of treatment) and 14(follow up evaluation after 6 weeks from the last treatment) visit
WOMAC scale is checked by the patients. WOMAC scale is a tool to check of the disability, stiffness and pain by knee pain.
次要结局
- 100mm Pain Visual Analogue Scale(at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13(after 6 weeks of treatment), and 14th(follow up evaluation after 6 weeks from the last treatment) visit)
- 6 Minute walk test(at 2nd(Baseline),8(after 3weeks of treatment),13th(after 6 weeks of treatment) and 14(follow up evaluation after 6 weeks from the last treatment) visit)
- WOMAC pain(at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13(after 6 weeks of treatment), and 14th(follow up evaluation after 6 weeks from the last treatment) visit)
- Investigator global assessment(IGA)(at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13(after 6 weeks of treatment), and 14th(follow up evaluation after 6 weeks from the last treatment) visit)
- Patient global assessment(PGA)(at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13(after 6 weeks of treatment), and 14th(follow up evaluation after 6 weeks from the last treatment) visit)
- Adverse Events(at 2(Baseline), 3, 4, 5, 6, 7, 8(after 3weeks of treatment), 9, 10, 11, 12, 13th(end of treatment) visit)
研究者
Eun Jung Kim
Research professor
DongGuk University