Comparison of Different Acupuncture Methods on Knee Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
研究概览
简要总结
The purpose of this study is to test if specific therapeutic benefits of acupuncture are mostly attributable to contextual and psychosocial factors, such as patients' beliefs and expectations.The investigators propose using the 2 acupuncture methods, which refrains from inserting needles in the affected area, in order to evaluate the short-term and long-term efficacy of acupuncture in a clinical setting compared with placebo and compared with invasive needling that does not adhere to "correct" acupuncture rules.
详细描述
The main novel features of this study:
- First aim to assess the effect of distal needling on knee pain
- Second aim to directly compare two acupuncture techniques, placebo, needling at "wrong" places and "correct" needling for knee pain
Advantages of the study compared to published data:
- Distal needling - enables assessment of range of motion (ROM) and pain level during needling.
- Both acupuncture systems rely on minimal questioning, which simplifies the patient-practitioner interactions.
- Exploratory studies in the clinic of DP show that it is possible to distinguish between "correct" and "incorrect" needling, at least in the short term. Long term effects have not been assessed yet.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (> 18 years old), suffering chronic stable pain score >40 mm on 100 mm VAS of the knee due to patellar tendonitis.
- •Patients have had X-rays or other tests confirming they are not candidates for surgery nor are scheduled for steroid injections or hyaluronic acid injections within 8 weeks from the beginning of the study.
- •Adult patients (> 18 years old), two weeks after ACL reconstruction surgery (with or without meniscal involvement), with pain score >40 mm on 100 mm VAS of the knee (all patients at this stage have significant ROM limitation).
排除标准
- •Patient refusal
- •Pregnancy
- •Morbid obesity
- •Peripheral vascular disease
- •Lower limb neurological deficit (such as multiple sclerosis, nerve palsy), other serious co-morbidity (including severe back pain or hip pain)
- •A history of prolonged or current steroid use
- •Received hyaluronic acid injections within the previous 3 months
- •Have needle phobia or allergy to sticking plaster.
结局指标
主要结局
Effect of Distal Needling on Knee Pain Using Acupuncture Techniques
时间窗: 2 years
Effect of Distal Needling on Knee Pain Using 4 different Acupuncture Techniques by: 1. Pain measurement by Visual Analogue Scale (VAS) 2. Range of motion (ROM)
次要结局
未报告次要终点
研究者
Elyad Davidson
PI Head Pain Unit
Hadassah Medical Organization