Functional Magnetic Resonance Imaging Analysis of the ClinicalEffect and Cerebral Mechanism of Tuina in Lumbar Disc Herniation: Protocol for a Randomized Controlled Parallel GroupTrial

Background: Lumbar disc herniation (LDH) has become a serious public health and socioeconomic problem. Tuina is a Chinesemedicine treatment method based on meridian acupuncture theory and modern anatomy. Tuina can relieve pain and muscletension and improve functional disorders; this massage is performed by pressing, kneading, pushing, pulling, and shaking theskin, muscles, and bones. However, the mechanism of action and the effect of Tuina as an external treatment on the activities ofthe central nervous system to relieve LDH pain is unclear. Therefore, we performed functional magnetic resonance imaging(fMRI), which is widely used in pain-related research, as it can detect the effects of different types of pain on brain activity.Objective: Our randomized controlled parallel-group trial aims to compare the effects of Tuina with those of transcutaneouselectrical nerve stimulation (TENS) with traction in patients with LDH.Methods: This trial will be conducted between May 2024 and April 2025 in the Rehabilitation Hospital affiliated to FujianUniversity of Traditional Chinese Medicine. Seventy-six participants with LDH will be enrolled for this trial and randomlyassigned to 2 groups: Tuina intervention group and TENS with traction intervention group. Participants in both groups will receivetreatment for 14 days. fMRI will be performed for the main pain measurements by assessing the effect of the intervention onbrain activity before and after the end of the intervention. Short-Form McGill Pain Questionnaire, pressure pain thresholds, andthe Oswestry disability index will be used to reflect the degree of pain and lumbar dysfunction, and the results will be used assecondary outcome measurements.Results: The study protocol has been approved by the ethics review committee of The Rehabilitation Hospital affiliated toFujian University of Traditional Chinese Medicine. This study was registered on May 1, 2024, with the Chinese Clinical TrialRegistry. Data collection began on May 2024 and is expected to end on April 2025. Currently, data from this trial are in thecollection phase, and no data analysis has been performed. As of July 1, 2024, we have collected data from 21 patients. Theresults of this trial are expected to be submitted for publication in September 2025.Conclusions: This clinical trial will compare the effectiveness of Tuina with that of TENS with traction in the treatment ofpatients with LDH and will show the cerebral mechanism of Tuina in LDH treatment by using fMRI. The results of our trial willbe helpful in clarifying the cerebral mechanism of Tuina in the treatment of LDH and provide a solid foundation for Tuina therapyresearch.Trial Registration: Chinese Clinical Trial Registry ChiCTR2400083784; https://www.chictr.org.cn/showproj.html?proj=225157.