Clinical Efficacy and Central Mechanisms of Electroacupuncture Treatment for Low Back Pain in Primary Osteoporosis: Study Protocol for a Randomized Controlled Trial

Abstract Background Primary osteoporosis is a common disease in the elderly, often causing low back pain and limited mobility. Electroacupuncture is considered a combination of traditional acupuncture and modern transcutaneous electrical nerve stimulation. Due to its strong stimulation, it has shown certain efficacy in relieving low back pain associated with primary osteoporosis (POP). It has the potential to be a complementary or alternative treatment for drug therapy of POP-related low back pain. However, the underlying mechanisms have not been fully elucidated. Therefore, this study, by evaluating the efficacy of electroacupuncture in treating POP-related low back pain, aims to explore the potential central mechanisms using resting-state functional magnetic resonance imaging (rs-fMRI). Methods This study is a randomized controlled trial in which 60 patients were randomly divided into two groups: the calcium group (n = 30) and the calcium + electroacupuncture group (n = 30). The study lasted for 17 weeks, including a 1-week baseline, 4 weeks of treatment, and 12 weeks of follow-up (at the 4th and 12th week after treatment). The primary outcome measure is McGill Pain Questionnaire (MPQ), and secondary outcome measures include the Oswestry dysfunction index(ODI), Young's Modulus, and the use of analgesic medications after treatment. These measures will be used to evaluate the clinical efficacy of the two intervention methods for treating low back pain associated with primary osteoporosis (POP). Twenty patients from each group will be randomly selected for rs-fMRI examinations to observe changes in brain functional activity and correlate them with changes in pain severity. Discussion This study aims to evaluate the clinical efficacy and potential central mechanisms of electroacupuncture in treating low back pain associated with POP. Provided that we obtain imaging-based evidence of the effectiveness of electroacupuncture intervention for POP-related low back pain, this study will provide supporting evidence for the clinical application of electroacupuncture in the treatment of low back pain associated with POP. Trial registration: Chinese Clinical Trial Registry ChiCTR2300075736. Registered on 14 September 2023