Evaluation of the efficacy of electroacupuncture on pain and tolerance for unsedated colonoscopy: A study protocol for a prospective, randomized, sham-controlled trial
电针对非镇静结肠镜检查疼痛和耐受性的评估:一项前瞻性随机对照试验方案

Yang ZHANG(张杨)^a, Zhi-dan WANG（王志丹）^a, Jie ZHANG（张杰）^a, Shuang REN（任爽）^a, Yue LIU（刘悦）^a,Yun-xi LI（李赟溪）^a, Xiao-yu MA（马晓宇）^b, Xu WANG（汪旭）^b, Hao SUN（孙皓）^c, Ruo-shi LIU（刘若实）^a

^a Department of Traditional Chinese Medicine, The First Hospital of China Medical University, Shenyang 110001, China（中国医科大学附属第一医院中医科，沈阳110001，中国）

^b Department of Endoscope, The First Hospital of China Medical University, Shenyang 110001, China（中国医科大学附属第一医院内窥镜室，沈阳110001，中国）

^C Department of Clinical Epidemiology, The First Hospital of China Medical University, Shenyang 110001, China（中国医科大学附属第一医院流行病学研究室，沈阳110001，中国）

Abstract

Background: Unsedated colonoscopy is an important method used for diagnosing colorectal cancer, but which can cause discomfort such as pain and bloating, as well as anxiety. At present, the relief is mainly achieved through methods such as changing positions and manual pressing, but the efficacy is limited. Hence alternative therapies for sedation and analgesia in unsedated colonoscopy warrant further study. Electroacupuncture (EA) can simplify the procedure of anesthesia and analgesia, while the efficacy of EA on unsedated colonoscopy remains unclear. Therefore, a well-designed randomized controlled trial is needed to demonstrate the potential efficacy of acupuncture in unsedated colonoscopy, particularly for pain relief.

Methods: In this prospective randomized sham-controlled trail, 105 eligible participants will be recruited and randomly assigned to either EA group (n=35), sham EA group (n=35), or control group (n=35) in a 1:1:1 ratio.

The EA group will received acupuncture intervention on bilateral Hegu (LI4), Neiguan (PC6), Zusanli (ST36), and Shenmen (HT7), with LI4 and PC6 on both sides connected to the EA device.

The sham EA group will received non transdermal needling on points of no meridian, and deliberately connect the needle to the incorrect output socket of EA device to block the stimulation.

The needling will conducted from 30 min before the unsedated colonoscopy to the end of the colonoscopy, the whole retention time would be approximately 40 min. The participants in the control group will not receive any acupuncture intervention. All participants of three groups will not receive any other treatment.

Primary outcomes: Numerical Rating Scale (NRS) reported by participants and Face Pain Scale Revised (FPS-R) evaluated by observers of four areas of the participants during the unsedated colonoscopy. Secondary outcomes: tolerance reported by endoscopists, tolerance reported by participants, satisfaction reported by endoscopists, satisfaction reported by participants, adverse events during the unsedated colonoscopy, postoperative discomfort, unsedated colonoscopy smoothness (cecal insertion time, unwinding time, success rate of one-time intubation). Both intention-to-treat (ITT) and per-protocol (PP) analyses will be performed to assess the efficacy of EA.

Discussion: The trial will explore the efficacy in relieving pain, improving tolerability, and reducing undesirable adverse events of EA for unsedated colonoscopy. The results of this trial will provide sound evidence for promoting the clinical application of EA for unsedated colonoscopy.

Trial registration: ClinicalTrials.gov Identifier: ChiCTR2300069903, retrospectively registered on March 16, 2023.

【摘要】

背景：非镇静性结肠镜检查是诊断结直肠癌的重要方法，然而该检查会引起疼痛、腹胀、焦虑等不适。目前主要通过变换体位、手法按压等方法缓解，但效果有限。因此在非镇静结肠镜检查中镇静和镇痛的替代疗法值得进一步研究。电针可简化针刺镇静及镇痛的程序，但其对非镇静性结肠镜的特异性疗效尚不清楚。因此，需要一项设计良好的随机对照试验来证明针灸在非镇静结肠镜检查中的潜在疗效。

方法：在这项前瞻性随机对照试验中，拟招募105名参与者，并按1∶1∶1的比例随机分配到电针组、假电针组和空白组，每组各35例。电针组于双侧合谷、内关、足三里和神门处接受针刺，其中两侧的合谷和内关连接电针。假电针组于3个非经非穴处接受非透皮针刺，并被连接到错误的电针装置输出插座上来模拟电流刺激。两组针刺时间均为从非镇静结肠镜检查前30 min至手术结束，全程约40 min。空白组不接受任何针刺干预。三组均不接受任何其他干预。主要疗效指标：行结肠镜检查时患者4个部位的疼痛数字评定量表（Numeric Rating Scale , NRS）评分和面部表情疼痛改良量表(Faces pain Scale-Revised , FPS-R)评分。次要疗效指标：医生报告的耐受性、受试者报告的耐受性、医生报告的满意度、受试者报告的满意度，手术过程中的不良反应，非镇静结肠镜术后的不适感和非镇静结肠镜检查的顺利度(包括盲肠插入时间、解除时间和一次性插管成功率)。将进行意向治疗(ITT)和每个方案(PP)分析，以评估试验的特异性疗效。

讨论：该试验将有助于评估电针在非镇静结肠镜检查中减轻疼痛、提高耐受性和减少不良反应的特异性疗效。本研究结果将为促进电针在非镇静结肠镜检查中的临床应用提供良好的依据。

试验注册:ClinicalTrials.gov (ChiCTR2300069903)，回顾性注册于2023年3月16日。