STUDY PROTOCOL article
Front. Neurol.
Sec. Experimental Therapeutics
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1632822
Electro-acupuncture for irritable bowel syndrome with constipation: study protocol of a pilot, randomized, double-blinded, sham-controlled trial
Provisionally accepted
- 1Nanyang Technological University, Singapore, Singapore
- 2Harvard T H Chan School of Public Health, Boston, United States
- 3National University Hospital, Singapore, Singapore
- 4National University of Singapore, Singapore, Singapore
- 5Wake Forest University, WinstonSalem, United States
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Introduction: Irritable bowel syndrome with constipation (IBS-C) is a common functional gastrointestinal disorder characterized by constipation, abdominal discomfort, and a substantial impact on patients' quality of life. While acupuncture could be effective in treating general IBS, high-quality clinical evidence specifically supporting its efficacy in IBS-C remains limited. Our study aims to address this gap by evaluating the effectiveness and safety of electro-acupuncture in managing IBS-C symptoms. Methods: This a multicentre, randomized, double-blinded, sham-controlled trial. A total of 60 IBS-C patients are randomized to receive either electro-acupuncture (n=30) or sham acupuncture (n=30). Patients undergo a 2-week screening period, followed by 6 weeks of treatment (12 sessions) and 6 weeks of follow-up. From the beginning of the screening period to the end of the trial, patients are instructed to complete daily diaries recording bowel movement timing, stool consistency, straining severity, sensation of complete or incomplete evacuation, and the name and dosage of any medications taken. The primary outcome measure follows the FDA-recommended endpoint for IBS-C trials. Additionally, biological samples are collected to explore the potential mechanisms underlying the effects of acupuncture on IBS-C pathology. Ethics and dissemination: The protocol (version 1.4.4) has received approval from the Institutional Review Board of Nanyang Technological University (IRB-2023-451). Trial registration number: NCT06219707.
Keywords: Acupuncture1, irritable bowel syndrome2, Constipation3, Randomized ControlledTria4, food and drug administration5
Received: 23 May 2025; Accepted: 02 Sep 2025.
Copyright: © 2025 LAM, Chen, Siah, Thakur and Zhong. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Linda LD Zhong, Nanyang Technological University, Singapore, Singapore
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