雷火灸治疗腰椎间盘突出症的随机对照试验研究方案
The Effect of Thunder-Fire Moxibustion on Lumbar Disc Herniation: Study Protocol for a Randomized Controlled Trial.
机构信息
Institute of Basic Theory for Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing, China.
Graduate School, China Academy of Chinese Medical Sciences, Beijing, China.
出版信息
Front Public Health. 2022 Jul 6;10:930830. doi: 10.3389/fpubh.2022.930830. eCollection 2022.
BACKGROUND
Lumbar disc herniation (LDH) is a common disease seen in orthopedics; it is caused by nucleus pulposus herniation. Its clinical manifestations are low back pain, radiating pain of the lower limbs, and cauda equina symptoms that seriously affect patients' quality of life. At present, oral analgesics are commonly used in the treatment of LDH; but they can produce gastrointestinal reactions and other side effects. Thunder-fire moxibustion is a method that is widely used in China to treat pain syndromes. This study aimed to design a randomized controlled trial to explore the effectiveness and safety of thunder-fire moxibustion in the treatment of lumbar disc herniation.
METHODS
Ninety patients will be enrolled and randomly divided into one of two groups: the thunder-fire moxibustion group and the acetaminophen group. The thunder-fire moxibustion group will be treated with moxa sticks at BL25, GV3, BL23, and GV4; and after 15 min of local whirling moxibustion, the contralateral acupoints will be treated with moxibustion for 15 min. The study period will include two 10-day courses of treatment, for a total study duration of 20 days. The acetaminophen group participants will take one acetaminophen sustained-release tablet twice a day for the duration of the study period. In contrast, the thunder-fire moxibustion group participants will be treated with thunder-fire moxibustion every other day for 30 min. The primary outcome will be the Japanese Orthopedic Association (JOA) score. Visual analog scale (VAS) and Oswestry Disability Index (ODI) will be used as the secondary outcome measures. Adverse events (AEs) will also be recorded. Assessments will be conducted at baseline, the end of the first and second courses of treatment.
DISCUSSION
This study will determine whether thunder-fire moxibustion is more effective and safer than acetaminophen in the treatment of patients with LDH.
TRIAL REGISTRATION
Chinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR2000036079.
背景
腰椎间盘突出症（LDH）是骨科的常见病，是由髓核突出引起的。其临床表现为腰痛、下肢放射痛和马尾综合征，严重影响患者的生活质量。目前，LDH 的治疗多采用口服镇痛药，但会产生胃肠道反应等副作用。雷火灸是我国广泛用于治疗疼痛综合征的一种方法。本研究旨在设计一项随机对照试验，以探讨雷火灸治疗腰椎间盘突出症的有效性和安全性。
方法
将 90 例患者纳入研究并随机分为两组：雷火灸组和对乙酰氨基酚组。雷火灸组在 BL25、GV3、BL23 和 GV4 处使用艾条进行灸疗；15 分钟局部回旋灸后，对侧穴位灸疗 15 分钟。研究期间包括两个 10 天疗程，总研究时间为 20 天。对乙酰氨基酚组患者将在研究期间每天服用两次对乙酰氨基酚缓释片。相比之下，雷火灸组患者将每隔一天接受 30 分钟的雷火灸治疗。主要结局指标为日本骨科协会（JOA）评分。视觉模拟评分（VAS）和 Oswestry 残疾指数（ODI）将作为次要结局指标。还将记录不良事件（AEs）。评估将在基线、第一和第二疗程结束时进行。
讨论
本研究将确定雷火灸在治疗 LDH 患者方面是否比对乙酰氨基酚更有效、更安全。
试验注册
中国临床试验注册中心（http://www.chictr.org.cn），ChiCTR2000036079。
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