Evaluation of the efficacy of electroacupuncture on pain and tolerance for unsedated colonoscopy: A study protocol for a prospective, randomized, sham-controlled trial

Abstract

Background

Unsedated colonoscopy is an important method used for diagnosing colorectal cancer, but it 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 trial, 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 receive 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 the 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 of 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.