Clinical Outcome of Electro-Acupuncture in the Management of Knee Bi Syndrome:An Acupuncture And Energy Medicine Based Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
研究概览
简要总结
This study is a randomized controlled trial evaluating the effectiveness of electro-acupuncture in treating Knee Bi Syndrome, a TCM condition caused by obstruction of qi and blood due to cold-damp invasion. The research aims to measure improvements in knee range of motion, pain severity, disability, and inflammatory markers after treatment. Seventy participants aged 35–60 will be selected based on both clinical and TCM diagnostic criteria. The intervention group receives electro-acupuncture at six specific acupoints for 20 minutes, three times weekly for three weeks, while the control group receives no treatment during the study. Key outcome tools include a goniometer, the TCM Knee Bi Syndrome Assessment Questionnaire, the Pain Disability Index, and ESR testing. Randomization is done using computerized allocation and SNOSE concealment, though blinding is not used. Ethical considerations, informed consent, and participant confidentiality are comprehensively addressed. The document includes detailed methodology, inclusion and exclusion criteria, and standardized treatment procedures. A literature review highlights prior evidence showing electro-acupuncture’s analgesic and anti-inflammatory benefits. Overall, the study seeks to generate reliable evidence supporting electro-acupuncture for chronic knee pain within a TCM framework.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patients were diagnosed with knee pain (symptoms.
- •pain, swelling,warm,stiffness).2.The participants who have the range of motion (ROM) below 130°.3.Body mass index (BMI)lesser than 35.4.The participants are included under the TCM based knee bi syndrome questionaries (Bothmoderate and severe).
排除标准
- •1.Patients with severe osteoarthritis requiring surgical intervention or history of lower-limbjoint (knee joint) arthroplasty surgery.2.Presence of other diseases causing pain or dysfunction of the lower limb, apart from kneejoint disease.
- •(Lumbar disc herniation, Parkinson’s disease, Alzheimer’s disease, Neuromuscular disorder, etc.)3.Patients who had undergone any cardiovascular surgery (coronary stent or pacemaker)or epilepsy.4.Patients with Psychiatric conditions such as Schizophrenia or Depression.5.Pregnant or lactating women.6.Patients who are afraid of needles (Trypanophobia) & disorders of coagulopathy(e.g., hemophilia).7.Individuals who are undergoing chemotherapy sessions.8.Participation in another clinical study within the last 30 days.
研究者
Dr Dinesh kumar S
International Institute of Yoga and Naturopathy Medical Sciences
