Accepted for/Published in: JMIR Research Protocols
Date Submitted: Jul 1, 2024
Date Accepted: Aug 30, 2024
To explore the clinical effect and cerebral mechanism of Tuina on lumbar disc herniation based on fMRI: study protocol for a randomized controlled parallel trial
ABSTRACT
Background:
Lumbar disc herniation (LDH) has become a serious public health and socio-economic problem. As an effective external treatment for LDH, how Tuina affects the activities of the central nervous system to relieve LDH pain is unclear. Functional magnetic resonance imaging （fMRI） can detect the effects of different types of pain on brain activity, and it is widely used in pain-related research.
Objective:
The randomized controlled parallel trial will be conducted between Tuina and traction with transcutaneous electrical nerve stimulation (TENS) to evaluate the effects of Tuina in LDH patients.
Methods:
This will be a randomized controlled parallel trial conducted between May 2024 and May 2025.Seventy-six LDH participants will be enrolled in the treatment and randomly assigned to one of the two groups，the Tuina group and the traction with TENS group. Participants in both groups will receive treatment for 14 days. fMRI will be used as the main measurements of the results, which will be assessing the effect of treatment on brain activity before and after the end of the intervention. Short-form of McGill pain questionnaire (SF-MPQ), pressure pain thresholds (PPTs), and the Oswestry dysfunction index (ODI) can reflect the degree of pain and lumbar dysfunction and will be used as secondary outcome measurements.
Results:
Data collection began on May 1, 2024, and data collection is expected to end on April 30, 2025. Currently, data from this trial is in the collection phase and no data analysis has been performed, and as of July 1, 2024, we have collected data from 21 cases.
Conclusions:
This study as a clinical randomized controlled trial to compare the effectiveness of Tuina and traction combined with TENS in patients with LDH, and to investigate the cerebral mechanism of Tuina in LDH treatment 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. Clinical Trial: Registered in the Chinese Clinical Trial Registry (http://www.chictr.org.cn/searchproj.aspx, ChiCTR2400083784). Date of registration: 1 May 2024.
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