Li Min, Yuan Hongwen, Wang Pei, Xin Siyuan, Hao Jie, Liu Miaomiao, Li Jinfeng, Yu Man, Zhang Xinrui
Department of Acupuncture and Physical Therapy, Beijing Luhe Hospital Affiliated to Capital Medical University, No.82, Xinhua south street, Tongzhou District, Beijing, 101149, China.
School of Traditional Chinese Medicine, Capital Medical University, No.10, Xitoutiao, Outside of Youanmen, Fengtai District, Beijing, 100069, China.
Trials. 2017 Jun 5;18(1):251. doi: 10.1186/s13063-017-1975-7.
De Qi is a special sensational response upon acupuncture needling. According to traditional acupuncture theory, the treatment is "effective only after Qi arrival"; that is, De Qi is an important indicator of therapeutic efficacy and good prognosis. However, it is still disputable whether De Qi improves the efficacy of acupuncture therapy. This prospective, randomized controlled trial aims to explore the influence of De Qi induced by acupuncture on immediate and accumulated analgesic effects in patients with knee osteoarthritis (KOA).
METHODS/DESIGN: Eighty-eight patients with KOA will be recruited and randomly assigned to the De Qi group (enhanced stimulation to evoke De Qi) and the control group (weak stimulation to avoid De Qi) in the Department of Acupuncture and Physical Therapy, Beijing Luhe Hospital Affiliated to Capital Medical University. Each patient will receive three 30-minute sessions per week for 4 consecutive weeks and undergo a 1 month follow-up. The severity of knee pain, as measured on a 100-mm visual analog scale (where 0 indicates no pain and 100 indicates intolerable pain) will be used as the primary outcome, and the Knee injury and Osteoarthritis Outcome Score will be used as the secondary outcome. Both indexes will be measured before and after the 1 (for evaluating the immediate analgesic effects), 3, 6, 9, and 12 (for evaluating the accumulated analgesic effects) treatments and at the end of the follow-up. The intensity of the De Qi sensation will be assessed by the Chinese-Modified Massachusetts General Hospital Acupuncture Sensation Scale at the end of each treatment. Side effects during the treatments will be recorded and analyzed as well. The comparisons between the De Qi group and the control group will be done by using both an intention-to-treat analysis and a per-protocol analysis.
This prospective randomized controlled study will be helpful in enhancing our understanding of the analgesic effect of De Qi on patients with KOA and may provide a clinical basis for further investigation of the relationship between De Qi and the therapeutic efficacy of acupuncture, thereby offering some evidence for the role of De Qi in an efficacious acupuncture therapy.
Chinese Clinical Trial Registry, ChiCTR-IIR-16008972 . Registered on 4 August 2016 Additional file 2.
得气是针刺时一种特殊的感觉反应。根据传统针灸理论，“气至而有效”，即得气是治疗效果和良好预后的重要指标。然而，得气是否能提高针刺治疗效果仍存在争议。这项前瞻性随机对照试验旨在探讨针刺诱导的得气对膝骨关节炎（KOA）患者即时和累积镇痛效果的影响。
方法/设计：将招募88例KOA患者，随机分配至首都医科大学附属北京潞河医院针灸理疗科的得气组（增强刺激以诱发得气）和对照组（弱刺激以避免得气）。每位患者每周接受3次30分钟的治疗，连续4周，并进行1个月的随访。以100毫米视觉模拟量表（0表示无疼痛，100表示无法忍受的疼痛）测量的膝关节疼痛严重程度将作为主要结局指标，膝关节损伤和骨关节炎结局评分将作为次要结局指标。这两个指标将在第1次（用于评估即时镇痛效果）、第3次、第6次、第9次和第12次（用于评估累积镇痛效果）治疗前后以及随访结束时进行测量。每次治疗结束时，将采用中国改良的麻省总医院针刺感觉量表评估得气感觉的强度。治疗期间的副作用也将进行记录和分析。得气组和对照组之间的比较将采用意向性分析和符合方案分析。
这项前瞻性随机对照研究将有助于增强我们对得气对KOA患者镇痛作用的理解，并可能为进一步研究得气与针刺治疗效果之间的关系提供临床依据，从而为得气在有效针刺治疗中的作用提供一些证据。
中国临床试验注册中心，ChiCTR-IIR-16008972。于2016年8月4日注册 附加文件2。
