Accepted for/Published in: JMIR Research Protocols
Date Submitted: Sep 16, 2023
Open Peer Review Period: Sep 16, 2023 - Nov 11, 2023
Date Accepted: Jan 17, 2024
Date Submitted to PubMed: Jan 19, 2024
(closed for review but you can still tweet)
Cerebral Mechanism of Tuina on the Descending Pain Inhibitory System in Knee Pain: Study Protocol for a Randomized Controlled Parallel Trial
ABSTRACT
Background:
Tuina, a manual therapy, is effective and safe for reducing clinical symptoms of knee osteoarthritis (KOA); however, the mechanism that influences pain through the descending pain inhibitory system in KOA is unclear.
Objective:
We aim to investigate the modulatory implications of Tuina on the rostral ventromedial medulla (RVM) and periaqueductal grey (PAG), which have critical roles in the descending pain inhibitory system in patients with KOA.
Methods:
This randomized controlled parallel trial will be conducted at the Tuina Clinic of the Third Affiliated Hospital of Henan University of Chinese Medicine (Zhengzhou, China). Patients with KOA will be randomly assigned (1:1) to 6 weeks of health education or Tuina. Functional and structural magnetic resonance imaging, pressure pain thresholds, numerical rating scale, Hamilton Anxiety Scale, Western Ontario and McMaster Universities Osteoarthritis Index, and Hamilton Depression Scale will be conducted at the beginning and end of the experiment. We will use PAG and RVM as seeds in resting-state functional connectivity (rsFC) analysis. Adverse events will be documented and assessed throughout. The outcome evaluators and data statisticians will be masked to the treatment group assignment to reduce the risk of bias.
Results:
This trial was approved by the Ethics Committee of the Third Affiliated Hospital of Henan University of Chinese Medicine. Enrollment began in December 2023, and the results of this trial are expected to be submitted for publication in May 2025.
Conclusions:
Our trial will provide evidence on the effect of Tuina on rsFC in patients with KOA and identify a possible relationship between rsFC changes and improvement of clinical variables, elucidating the effect of Tuina on the descending pain inhibitory system of patients with KOA. Clinical Trial: Chinese Clinical Trial Registry (ChiCTR2300070289). Date of registration: 7 Apr 2023.
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