Ma's Bamboo-Based Medicinal Moxibustion Therapy of Low Back Pain in Lumbar Disc Herniation: Study Protocol for a Randomized Controlled Trial
Abstract Background Lumbar disc herniation (LDH) is a common and frequently-occurring disease in clinic. Low back pain and sciatica are the presenting symptoms of LDH. To some extent, it can be considered that measures with the capability to improve low back pain or sciatica have the potential to treat LDH. Ma's bamboo-based medicinal moxibustion therapy can effectively reduce the degree of low back pain and has been widely used. Studies of small sample size have seen significant improvement on pain relief. Methods/design: The trial is a multicenter, randomized, parallel-group, non-inferiority study. Three hundred and twelve patients will be randomly assigned to a Ma's bamboo-based medicinal moxibustion group (n=156) and an acupuncture group (n=156).Patients in each group will receive treatment every day,6 times a week, 12 times in total. Follow-up will be conducted 14 days after treatment. The primary outcome will be the visual analogue scale(VAS)at baseline, after 6 times of treatment,the end of treatment, and follow-up. the secondary outcomes will include Oswestry disability indexes (ODI) ,modified Japanese Orthopaedic Association low back pain (M-JOA) score,serum β-endorphin (β-EP) and serum substance P (SP). β-EP and SP as well as safety evaluation indexes (routine blood test, liver and kidney function, and ECG) will be measure at baseline and after the end of treatment. Discussion The results of the trial will compare the efficacy on low back pain in LDH between Ma's bamboo-based medicinal moxibustion group and acupuncture group and will be expected to make a systematic and objective evaluation on the clinical efficacy and safety of Ma's bamboo-based medicinal moxibustion therapy. Trial registration: ChiCTR, ChiCTR2000038725. Registered on 29 September 2020.