The Efficacy and Brain Network Mechanism of Acupuncture for Knee Osteoarthritis: A Study Protocol for Randomized Controlled Neuroimaging Trial.

Purpose: Knee osteoarthritis (KOA) is a prevalent degenerative bone and joint disease observed in clinical practice. While acupuncture has demonstrated efficacy in treating KOA, the central mechanisms underlying its effects remain ambiguous. Recently, functional magnetic resonance imaging (fMRI) has been extensively applied in studying the brain mechanisms of acupuncture analgesia. Currently, network analysis based on brain connectomics is a focal point in acupuncture imaging research. Therefore, this study uses KOA as the research vehicle, focuses on the abnormal connectivity patterns of brain functional networks, and integrates clinical pain assessments to thoroughly investigate the central mechanisms of acupuncture therapeutic effects on KOA. Patients and Methods: In this parallel, randomized, sham-controlled neuroimaging trial, 60 KOA patients will be randomly divided into the acupuncture group and sham acupuncture group in a 1:1 ratio, treated three times weekly for a total of 12 sessions. Patients will undergo clinical symptom assessments and cranial fMRI scans at baseline (-1-0 weeks), post-treatment (4 weeks), and at the follow-up (16 weeks). Forty healthy subjects will be recruited for observation, with a single MRI scan conducted only at baseline (-1-0 week). The primary efficacy indicator will be the change in NRS score after four weeks of treatment, with secondary outcomes including WOMAC, STAI, and safety assessments. fMRI observations will employ independent component analysis, brain network construction, and functional connectivity, complemented by Pearson correlation analysis to explore the relationship between brain responses and clinical improvements. Conclusion: This study will initially uncover how acupuncture intervention for chronic KOA pain centrally regulates and exerts therapeutic effects through the modulation of abnormal brain network functional connectivity patterns, with a demonstrated long-term effect. Ethics and Dissemination: This study has been approved by the ethics committee of Shandong University of Traditional Chinese Medicine Affiliated Hospital ((2024) Lunshen No. (028) - KY). Clinical Trial Registration: This study has been approved by registered in the Chinese Clinical Trial Registry (ChiCTR2400083695).