Cao Ying, Tu Jian-Feng, Shi Guang-Xia, Wang Li-Qiong, Jia Lian-Cheng, Li Bo, Liu Bao-Li, Yao Wei-Hai, Pei Xiao-Lu, Qu Zhi-Cheng, Liu Cun-Zhi
Emergency Department, Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, 23 Meishuguanhou Street, Dongcheng District, Beijing, 100010, China.
International Acupuncture and Moxibustion Innovation Institute, School of Acupuncture-Moxibustion and Tuina, Beijing University of Chinese Medicine, No. 11, Bei San Huan Dong Lu, Chaoyang District, Beijing, 100029, China.
Trials. 2021 Sep 25;22(1):652. doi: 10.1186/s13063-021-05600-2.
Acute renal colic caused by urinary calculi (ARCUC) has a considerable impact on the quality of life. Acupuncture might be a potential treatment option. However, the evidence is limited. We will conduct this trial to evaluate the efficacy and safety of acupuncture as adjunctive treatment to diclofenac for ARCUC.
METHODS/DESIGN: A total of 80 eligible patients who are diagnosed with urinary stone renal colic will be randomly allocated to the acupuncture group or the sham acupuncture group. Each patient will receive 1 session of acupuncture or sham acupuncture. The primary outcome will be the response rate of patients achieving a reduction of > 50% on visual analog score (VAS) from baseline to 10 min after treatment. Secondary outcomes will include the VAS, remedial analgesia, re-visit and admission rate, blinding assessment, credibility and expectancy, and adverse event. All patients who receive randomization will be included in the intent-to-treat analysis.
The finding of this trial will provide evidence on the efficacy and safety of acupuncture for the treatment of ARCUC. The results of this study will be published in peer-reviewed journals.
ClinicalTrials.gov ChiCTR 1900025202 . Registered on August 16, 2019.
尿路结石引起的急性肾绞痛（ARCUC）对生活质量有相当大的影响。针灸可能是一种潜在的治疗选择。然而，证据有限。我们将进行这项试验，以评估针灸作为双氯芬酸辅助治疗ARCUC的疗效和安全性。
方法/设计：总共80名被诊断为尿路结石肾绞痛的合格患者将被随机分配到针灸组或假针灸组。每位患者将接受1次针灸或假针灸治疗。主要结局将是患者从基线到治疗后10分钟视觉模拟评分（VAS）降低>50%的反应率。次要结局将包括VAS、补救性镇痛、复诊和入院率、盲法评估、可信度和期望值以及不良事件。所有接受随机分组的患者将纳入意向性分析。
本试验的结果将为针灸治疗ARCUC的疗效和安全性提供证据。本研究结果将发表在同行评审期刊上。
ClinicalTrials.gov ChiCTR 1900025202。于2019年8月16日注册。
