针刺膝关节骨关节炎疼痛阈值较低与较高穴位的效果：一项多中心随机对照试验
Effects of acupuncture at acupoints with lower versus higher pain threshold for knee osteoarthritis: a multicenter randomized controlled trial.
作者信息
Liu Jiali, Li Ying, Li Ling, Luo Xiaochao, Li Ning, Yang Xuguang, Zhang Hongxing, Liu Zhibin, Kang Deying, Luo Yanan, Liu Yanmei, Jia Yulong, Ren Yan, Yao Minghong, Wang Yuning, Chen Jin, Maiji Mewujia, Zou Kang, Zhao Ling, Liang Fanrong, Sun Xin
机构信息
Chinese Evidence-Based Medicine Center and Cochrane China Center, West China Hospital, Sichuan University, 37 Guo Xue Xiang, Chengdu, 610041, Sichuan, China.
NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, Sichuan, China.
出版信息
Chin Med. 2022 Jun 8;17(1):67. doi: 10.1186/s13020-022-00626-3.
BACKGROUND
The acupoint selections impact the effects of acupuncture, and preliminary evidence showed potential connection between pain threshold (PT) and acupuncture response. This study examined whether acupuncture at acupoints with lower PT versus higher PT would yield different effects in patients with knee osteoarthritis (KOA).
METHODS
In this multicenter randomized clinical trial, patients were randomly assigned (1:1:1) to receive acupuncture at acupoints with lower PT (LPT group), acupuncture at acupoints with higher PT (HPT group), and no acupuncture (waiting-list group). PT was measured with electronic von Frey detector. The primary outcome was the change in WOMAC total score from baseline to 16 weeks, and the secondary outcomes were SF-12 score, and active knee range of motion (ROM). Intention-to-treat analysis was conducted with linear mixed-effect model.
RESULTS
Among 666 randomized patients, 625 (93.84%) completed the study. From baseline to 16 weeks, patients in the LPT group versus HPT group had similar effects in reducing WOMAC total score (adjusted mean difference (MD) 2.21, 95% confidence interval (CI) -2.51 to 6.92, P = 0.36), while a greater reduction in WOMAC total score was observed in LPT group (-9.77, 95% CI -14.47 to -5.07, P < 0.001) and HPT group (-11.97, 95% CI -16.71 to -7.24, P < 0.001) compared with waiting-list group. There were no differences in SF-12 score and knee ROM between LPT versus HPT groups.
CONCLUSION
Our findings found that the effects of acupuncture at acupoints with lower versus higher PT were similar, both were effective for patients with KOA.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT03299439. Registered 3 October 2017, https://clinicaltrials.gov/ct2/show/NCT03299439.
背景
穴位选择会影响针刺效果，初步证据显示痛阈（PT）与针刺反应之间可能存在关联。本研究旨在探讨针刺痛阈较低穴位与痛阈较高穴位对膝骨关节炎（KOA）患者是否会产生不同的效果。
方法
在这项多中心随机临床试验中，患者被随机分配（1:1:1）接受针刺痛阈较低的穴位（低痛阈组）、针刺痛阈较高的穴位（高痛阈组）以及不接受针刺（等待列表组）。使用电子von Frey探测器测量痛阈。主要结局指标为从基线至16周WOMAC总分的变化，次要结局指标为SF-12评分以及膝关节主动活动范围（ROM）。采用线性混合效应模型进行意向性分析。
结果
在666例随机分组的患者中，625例（93.84%）完成了研究。从基线至16周，低痛阈组与高痛阈组患者在降低WOMAC总分方面效果相似（调整后平均差值（MD）为2.21，95%置信区间（CI）为-2.51至6.92，P = 0.36），而与等待列表组相比，低痛阈组（-9.77，95%CI为-14.47至-5.07，P < 0.001）和高痛阈组（-11.97，95%CI为-16.71至-7.24，P < 0.001）的WOMAC总分降低幅度更大。低痛阈组与高痛阈组之间的SF-12评分和膝关节ROM无差异。
结论
我们的研究结果发现，针刺痛阈较低穴位与痛阈较高穴位的效果相似，两者对KOA患者均有效。
试验注册
ClinicalTrials.gov标识符：NCT03299439。于2017年10月3日注册，https://clinicaltrials.gov/ct2/show/NCT03299439。
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