Functional Magnetic Resonance Imaging Analysis of the Clinical Effect and Cerebral Mechanism of Tuina in Lumbar Disc Herniation: Protocol for a Randomized Controlled Parallel Group Trial
Authors: Jiang Changzheng , Huang Hongye , Chen Lechun , Jiang Jingjing , Zhang Huanzhen , Chen Jincheng , Chen Shuijin , Lin Zhigang 
Published: August 2024

Background
Lumbar disc herniation (LDH) has become a serious public health and socioeconomic problem. Tuina is a Chinese medicine treatment method based on meridian acupuncture theory and modern anatomy. Tuina can relieve pain and muscle tension and improve functional disorders; this massage is performed by pressing, kneading, pushing, pulling, and shaking the skin, muscles, and bones. However, the mechanism of action and the effect of Tuina as an external treatment on the activities of the 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 transcutaneous electrical 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 Fujian University of Traditional Chinese Medicine. Seventy-six participants with LDH will be enrolled for this trial and randomly assigned to 2 groups: Tuina intervention group and TENS with traction intervention group. Participants in both groups will receive treatment for 14 days. fMRI will be performed for the main pain measurements by assessing the effect of the intervention on brain activity before and after the end of the intervention. Short-Form McGill Pain Questionnaire, pressure pain thresholds, and the Oswestry disability index will be used to reflect the degree of pain and lumbar dysfunction, and the results will be used as secondary outcome measurements.

Results
The study protocol has been approved by the ethics review committee of The Rehabilitation Hospital affiliated to Fujian University of Traditional Chinese Medicine. This study was registered on May 1, 2024, with the Chinese Clinical Trial Registry. Data collection began on May 2024 and is expected to end on April 2025. Currently, data from this trial are in the collection phase, and no data analysis has been performed. As of July 1, 2024, we have collected data from 21 patients. The results 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 of patients with LDH and will show the cerebral mechanism of Tuina in LDH treatment by using fMRI. The results of our trial will be helpful in clarifying the cerebral mechanism of Tuina in the treatment of LDH and provide a solid foundation for Tuina therapy research.

Trial Registration
Chinese Clinical Trial Registry ChiCTR2400083784; https://www.chictr.org.cn/showproj.html?proj=225157

International Registered Report Identifier (IRRID)
DERR1-10.2196/63852