Efficacy of Acupuncture Therapy Versus Sham Acupuncture on Knee Osteoarthritis: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 480
- 试验地点
- 9
- 主要终点
- Response rate
研究概览
简要总结
Knee osteoarthritis (KOA), also called degenerative knee disease, is one of the most common bone and joint diseases in clinic. It was estimated to affect more than 9 million individuals in the United States in 2005 and is a leading cause of disability and medical costs. Most elderly people over the age of 65 have radiographic and/or clinical evidence of osteoarthritis. KOA is a lifelong disease which can lead to obvious pain, joint stiffness, limitation of activity and even joint failure or disability. Acupuncture is a popular treatment taken from ancient Chinese medicine, in which fine needles are placed into the body at specific points. Studies have shown that acupuncture can stimulate nerves under the skin, causing the body to produce natural pain-relieving substances (endorphins). However the evidences of acupuncture for KOA are contradictory. According to the review, intensive acupuncture with three sessions a week is more effective for KOA than sparse acupuncture with one session a week. Moreover, the papers published in the past years suggest that manual acupuncture and electro-acupuncture are most commonly used acupuncture therapy for the treatment of knee osteoarthritis. The aim of this study is to evaluate the efficacy of intensive electro-acupuncture or manual acupuncture versus sham acupuncture in reducing pain and improving function in patients with KOA.
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 (Investigator, Outcomes Assessor)
盲法说明
Acupuncturist (Electro-acupuncture group and Manual acupuncture group), Participant, Outcome Assessor
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 45-75 years old, male or female
- •Single / bilateral knee pain, duration of more than 6 months
- •KL (Kellgren-Lawrence) grade Ⅱ or Ⅲ
排除标准
- •Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy)
- •Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, fracture, gout, lumbosacral vertebrae disease, etc.)
- •History of arthroscopy within 1 year or intra-articular injection within 4 months
- •History of receiving acupuncture or massage treatment within 3 months
- •Severe acute/chronic organic or mental diseases
- •Coagulation disorders (such as hemophilia, etc.)
- •Cardiac pacemaker, metal allergy or needle phobia
- •Pregnant women, pregnant and lactating women
- •Participation in another clinical study in the past 3 months
研究组 & 干预措施
Electro-acupuncture
5 compulsory acupoints (ST35、EX-LE5、LR8、GB33 and Ashi) and 3 optional matching acupoints (stomach meridian syndrome：ST34、ST36、ST32、ST40、EX-LE2；gallbladder meridian syndrome：GB31、GB36、GB34、GB39、GB41；bladder meridian syndrome：BL39、BL40、BL57、BL60；San Yin meridian syndrome：LR7、SP9、SP10、KI10、SP4、SP6、LR3、KI3) will be chosen. Needles will be stimulated manually to achieve "De Qi" sensation and an electrical apparatus (Nanjing Jisheng Medical Co., Ltd., wave of 2/100Hz) will be then connected to the needles with alligator clips in pairs LR8-GB33 and two other matching acupoints. The stimulus intensity will be increased until the patient reports a strong but comfortable intensity. Patients will receive 30-minute, 24 sessions intervention over eight weeks.
干预措施: acupuncture (Other)
manual acupuncture
Participants in the manual acupuncture group have the same schedule as the Electro-acupuncture group except that the electrical apparatus has working power indicator and sound without actual current output.
干预措施: acupuncture (Other)
sham acupuncture
Those in the sham acupuncture group receive shallow acupuncture at non-acupoints without manipulation，Deqi or actual current output.
干预措施: acupuncture (Other)
结局指标
主要结局
Response rate
时间窗: 8 weeks
the percentage of patients with improvement in average pain (numerical rating scale, NRS) at least 2 units and in Western Ontario and Mcmaster Universities Osteoarthritis Index (WOMAC) function subscale score at least 6 units at 8 weeks. Pain NRS was a self-administered instrument, a number selected from 0-10 by participant. Intensity of pain range (over past week): 0 =no pain to 10 =worst possible pain. Higher score indicating severe pain. The WOMAC function subscale referred to the participant's ability to move around and perform usual activities of daily living. The WOMAC function subscale was comprised of 17 questions regarding the degree of difficulty experienced due to OA in the study knee. The WOMAC function subscale score for each question ranged from 0 (minimum) to 4 (maximum), higher scores signified worse physical function. An overall score range of 0 (minimum) to 68 (maximum), with higher scores indicating worse physical function.
次要结局
- Knee-joint function(baseline, 8 weeks, 16 weeks and 26 weeks)
- Knee-joint stiffness(baseline, 8 weeks, 16 weeks and 26 weeks)
- Expectancy score(1 week（after the first treatment）)
- Blinding assessment(4 weeks and 8 weeks)
- Quality of life(baseline, 8 weeks, 16 weeks and 26 weeks)
- Credibility score(1 week（after the first treatment）)
- Global effect(8 weeks, 16 weeks and 26 weeks)
- Response rate(16 weeks, 26 weeks)
- Adverse events(first treatment up to 8 weeks)
- Knee-joint pain(baseline, 8 weeks, 16 weeks and 26 weeks)
研究者
Ping Zhou
Clinical Professor
Beijing Hospital of Traditional Chinese Medicine