Sun Yi-Yang, Wang Ming-Lin, Zhao Ruo-Han, Hao Ming-Yao, Song Shuai, Zhou Yue, Zhang Na
Department of Acupuncture-Moxibustion and Tuina, Shandong University of Traditional Chinese Medicine, Jinan, Shandong, People's Republic of China.
Traditional Chinese Medicine Comprehensive Treatment Center, Shengli Oilfield Central Hospital, Jinan, Shandong, People's Republic of China.
J Pain Res. 2025 Jan 23;18:391-404. doi: 10.2147/JPR.S500024. eCollection 2025.
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.
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.
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.
This study has been approved by the ethics committee of Shandong University of Traditional Chinese Medicine Affiliated Hospital ((2024) Lunshen No. (028) - KY).
This study has been approved by registered in the Chinese Clinical Trial Registry (ChiCTR2400083695).
膝关节骨关节炎（KOA）是临床常见的退行性骨与关节疾病。虽然针灸已被证明对治疗KOA有效，但其作用的核心机制仍不明确。近年来，功能磁共振成像（fMRI）已广泛应用于研究针刺镇痛的脑机制。目前，基于脑连接组学的网络分析是针刺成像研究的重点。因此，本研究以KOA为研究对象，聚焦脑功能网络的异常连接模式，并结合临床疼痛评估，深入探究针刺治疗KOA疗效的中枢机制。
在这项平行、随机、假针刺对照的神经影像学试验中，60例KOA患者将按1:1比例随机分为针刺组和假针刺组，每周治疗3次，共治疗12次。患者将在基线期（-1 - 0周）、治疗后（4周）和随访期（16周）接受临床症状评估和头颅fMRI扫描。招募40名健康受试者进行观察，仅在基线期（-1 - 0周）进行一次MRI扫描。主要疗效指标为治疗4周后NRS评分的变化，次要结局包括WOMAC、STAI及安全性评估。fMRI观察将采用独立成分分析、脑网络构建和功能连接，并辅以Pearson相关分析，以探索脑反应与临床改善之间的关系。
本研究将初步揭示针刺干预慢性KOA疼痛如何通过调节异常脑网络功能连接模式在中枢发挥调节和治疗作用，并具有长期疗效。
本研究已获得山东中医药大学附属医院伦理委员会批准（(2024)伦审字(028)-KY）。
本研究已在中国临床试验注册中心注册（ChiCTR2400083695）。
