The Effect of Thunder-Fire Moxibustion on Lumbar Disc Herniation: Study Protocol for a Randomized Controlled Trial

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.