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

BackgroundLumbar disc herniation (LDH) is one of the common diseases in orthopedics and traumatology, which is caused by nucleus pulposus herniation stimulating cauda equina nerve, nerve root and intervertebral disc degeneration. Its clinical manifestations are low back pain, radiation pain of lower limbs and cauda equina symptoms, which seriously affect the quality of life of patients. At present, oral analgesics are commonly used in clinical non drug therapy for LDH, but oral analgesics will produce gastrointestinal reactions and other side effects. Thunder-fire moxibustion is one kind of moxibustion method, which has been applied widely for treating pain syndromes in China. The aim of our research is to design a randomized controlled trial of thunder-fire moxibustion in the treatment of lumbar disc herniation to explore whether it is safer and more effective than oral analgesic drugs.Methods90 patients will be randomly divided into thunder-fire moxibustion group and acetaminophen group. The intervention included 10 days as a course of treatment, lasting for 20 days. The acetaminophen group took two acetaminophen sustained-release tablets every other day, while the thunder fire moxibustion group will be treated with thunder fire moxibustion once every other time for 30 minutes. Japanese Orthopaedic Association (JOA) score, visual analogue scale (VAS) and oswestry disability index (ODI) will be used as the main the observation indexes. Meanwhile, the occurrence of adverse events (AES) will also be recorded. The assessment will be conducted at baseline and at the end of the first and second course of treatment.DiscussionThe aim of this study is to determine whether thunder-fire moxibustion is more effective than acetaminophen in the treatment of patients with LDH.Trial registrationChinese Clinical Trial Registry (http://www.chictr.org.cn), ChiCTR2000036079. Registered on 21 August 2020.