Efficacy of Electro-acupuncture Versus Manual Acupuncture for Knee Osteoarthritis: a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Success 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 often occurs in middle-aged people, especially women. 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.According to the papers published in the past years, we find that acupuncture therapy for the treatment of knee osteoarthritis include manual acupuncture, electro-acupuncture, acupotomy, laser acupuncture, fire needle and so on, among which manual acupuncture and electro-acupuncture are most commonly used.The aim of this study is to compare the effectiveness of electro-acupuncture and manual acupuncture in reducing pain and improving function in patients with KOA.
详细描述
Participants will be randomly allocated to one of two groups. Those in the first group receive electro-acupuncture, which involves having needles inserted into acupuncture points (locations on the body affected by acupuncture) which are stimulated manually for 10 seconds to create "De Qi" sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator, Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) was then connected to the needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10. The stimulus intensity will be increased until the patient reported a strong but comfortable intensity. Those in the second 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. Both groups will receive 30-minute, 24 sessions intervention over eight weeks. Moreover, a number of questionnaires at the start of the study and then again after 4, 8, 12 and 16 week will be completed by participants.
It is expected that participants will benefit from a decrease in pain and improved function. The risks of participation are minimal. Occasionally, acupuncture can make people feel nauseous or experience a temporary increase in pain either during or after treatment. Rare side effects during acupuncture treatment include fainting, infection and subcutaneous hematoma (pooling of blood under the skin). Participants will be warned of these potential side-effects before consenting to have acupuncture.
Participants will be allowed, or required, to withdraw from the trial based on the following:
- A major protocol violation;
- Development of a serious disease preventing continuation in the trial;
- Adverse events related to acupuncture;
- Request to be withdrawn from the trial. The purpose is to accumulate clinical data, obtain the outcome data of the intervention method and prove the feasibility of the study protocol. Sixty patients will be selected as the sample size according to clinical experience.
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
- Triple (Participant, Investigator, Outcomes 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
- •VAS ≥ 40mm
- •Signed informed consent
排除标准
- •Surgery history of knee or waiting for surgery (knee replacement or knee arthroscopy)
- •History of arthroscopy within 1 year or intra-articular injection within 4 months
- •Knee pain caused by other diseases (such as joint bodies, severe effusion of joint cavity, infection, malignant tumors, autoimmune diseases, trauma, etc.)
- •Severe acute/chronic organic or mental diseases
- •Coagulation disorders (such as hemophilia, etc.)
- •Pregnant women, pregnant and lactating women
- •History of receiving acupuncture or massage treatment within one month
- •Participation in another clinical study in the past 3 months
- •With a cardiac pacemaker, metal allergy or needle phobia
研究组 & 干预措施
Electro-acupuncture group
After recruiting, patients are assigned to the electro-acupuncture group by randomization,and then receive electro-acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks.
干预措施: Electro-acupuncture (Device)
Manual acupuncture group
After recruiting, patients are assigned to the manual acupuncture group by randomization,and then receive manual acupuncture treatment.Both treatments consist of 24 sessions of 30 minutes duration, administered over 8 weeks (usually three sessions per week). Participants in both groups will be evaluated at baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks.
干预措施: Manual acupuncture (Device)
结局指标
主要结局
Success Rate
时间窗: baseline, 8 weeks
a change of 50% from baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain, stiffness and function scores at 8 weeks.
次要结局
- Stiffness(baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Inflammatory markers(baseline, 8 weeks)
- Knee-joint function(baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Credibility/expectancy questionnaires(baseline)
- Quality of life(baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Pain(baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Number of emergency analgesics (Celebrex/Loxonin) used(baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks)
- Adverse events(up to 16 weeks)
研究者
zhouping
Postgraduate Student
Beijing Hospital of Traditional Chinese Medicine