Department of Acupuncture, The Third Affiliated Hospital of Beijing University of Chinese Medicine, Beijing 100029, China.
J Tradit Chin Med. 2019 Feb;39(1):127-132.
To compare the efficacy of electroacupuncture (deep needling) and general orthopedics in treatment of lumbar disc herniation (LDH), and to evaluate its long-term efficacy.
This trial is a prospective cohort study. A total of 175 participants will be observed. The exposure group is obtained from department of acupuncture and moxibustion and the control group is from orthopedic department in hospital. Patients in exposed group will receive electroacupuncture in Dachangshu (BL 25), Guanyuanshu (BL 26), L4 Jiaji points (EX-B2 L4), L5 Jiaji points (EX-B2 L5) and S1 Jiaji points (EX-B2 S1) in the affected side once a day, 6 times as a treatment course for two courses (12 times). Patients in control group will receive orthopedic conventional therapy. In acute period, the treatment is mannitol injection (250 mL∶50 g) 200 mL, i.v., q.d.; 0.9% sodium chloride injection 250 mL, vitamin C injection 2 g, Dexamethasone sodium phosphate injection 10 mg, i.v., q.d.; sterile water for injection 2 mL, adenosine cobalt amine injection 1 mg, i.m., q.d., 12 d. In remission period, the treatment is Voltaren (Diclofenac diethyl lamine emulsion) external, q.d., 12 d. The researchers do not give any other intervention and record the relevant information only.
Modified Japanese Orthopaedic Association Scores, Visual Analogue Scale/Score, the Short Form-36 Quality-of-Life Questionnaire and Oswestry Disability Questionnaire and the second outcome measures (Adverse Event Questionnaire and Relapse Questionnaire) are measured before treatment, after the sixth treatment, and after the twelfth treatment. The follow-up periods are 3 months after the twelfth treatment, 6 months after the twelfth treatment, 1 year after the twelfth treatment.
This study will provide clinical researchers with the evidence on the safety and long-term efficacy of electroacupuncture in patients with Lumbar disc herniation.
比较电针（深刺）和一般骨科治疗腰椎间盘突出症（LDH）的疗效，并评价其长期疗效。
本试验为前瞻性队列研究。共观察 175 例患者。暴露组来源于针灸科，对照组来源于医院骨科。暴露组患者在患病侧接受电针治疗，穴位为大肠俞（BL25）、关元俞（BL26）、L4 夹脊穴（EX-B2L4）、L5 夹脊穴（EX-B2L5）和 S1 夹脊穴（EX-B2S1），每天一次，6 次为一疗程，共两疗程（12 次）。对照组患者接受骨科常规治疗。急性期，给予 250ml：50g 甘露醇注射液 200ml，静脉滴注，每日一次；0.9%氯化钠注射液 250ml，维生素 C 注射液 2g，地塞米松磷酸钠注射液 10mg，静脉滴注，每日一次；注射用水 2ml，腺苷钴胺注射液 1mg，肌内注射，每日一次，共 12 天。缓解期，给予扶他林（双氯芬酸二乙胺乳胶剂）外用，每日一次，共 12 天。研究者不给予任何其他干预，仅记录相关信息。
治疗前、第六次治疗后、第十二次治疗后测量改良日本矫形协会评分、视觉模拟量表/评分、简明健康状况调查问卷 36 项生命质量量表和 Oswestry 功能障碍指数问卷，以及第二次结果测量（不良事件问卷和复发问卷）。随访时间为第十二次治疗后 3 个月、第十二次治疗后 6 个月、第十二次治疗后 1 年。
本研究将为临床研究人员提供电针治疗腰椎间盘突出症患者的安全性和长期疗效的证据。
