{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T17:20:35Z","timestamp":1789147235893,"version":"build-2803163510"},"reference-count":31,"publisher":"BMJ","issue":"9","license":[{"start":{"date-parts":[[2025,9,30]],"date-time":"2025-09-30T00:00:00Z","timestamp":1759190400000},"content-version":"unspecified","delay-in-days":29,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Special Project of the Medical Administration Institute of the National Health Commission","award":["SZ2024HL010"],"award-info":[{"award-number":["SZ2024HL010"]}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,9,5]]},"published-print":{"date-parts":[[2025,9]]},"abstract":"<jats:sec>\n                  <jats:title>Introduction<\/jats:title>\n                  <jats:p>Colonoscopy is an essential procedure for the early diagnosis of colorectal conditions; however, over 60% of patients undergoing non-sedated colonoscopy report moderate to severe pain. This study aims to investigate the central analgesic mechanisms of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture theory (TENS-WAA). A multimodal approach combining electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) will be employed to assess pain-related brain activity, with artificial intelligence applied to model the relationship between objective neurophysiological signals and subjective pain experience.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>This is a single-centre, randomised, double-blind, controlled trial involving 60 patients undergoing colonoscopy without anaesthesia. Participants will be randomly allocated (1:1) to either an electrical stimulation group receiving TENS-WAA or a sham stimulation group. EEG and fNIRS data will be acquired before, during and after the procedure. The primary outcome is the analysis of EEG-fNIRS signals to characterise cerebral responses associated with pain modulation. Secondary outcomes include patient-reported pain using the Visual Analogue Scale (VAS), total colonoscopy duration and the correlation between EEG-fNIRS indicators and VAS scores. A deep learning framework will be used to enhance pain prediction accuracy.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>This study has received ethical approval from the Ethics Committee of Changhai Hospital, Shanghai (approval reference CHEC2025-006), and has been registered at ClinicalTrials.gov. Written informed consent will be obtained from all participants. Findings will be disseminated in peer-reviewed academic journals and at relevant scientific conferences, regardless of outcome, contributing to evidence-based, non-pharmacological pain management strategies.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>ClinicalTrials.gov, <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT06813703\">NCT06813703<\/jats:ext-link>.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-103681","type":"journal-article","created":{"date-parts":[[2025,10,1]],"date-time":"2025-10-01T08:05:59Z","timestamp":1759305959000},"page":"e103681","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Analysis of the analgesic mechanism of TENS-WAA in colonoscopy using the EEG-fNIRS system: a study protocol for a randomised controlled trial"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct06813703","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct06813703","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0009-0008-4982-1359","authenticated-orcid":false,"given":"Han","family":"Wang","sequence":"first","affiliation":[{"name":"University of Shanghai for Science and Technology, Shanghai, China"},{"name":"Department of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiaonan","family":"Huang","sequence":"additional","affiliation":[{"name":"Department of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lifan","family":"Xu","sequence":"additional","affiliation":[{"name":"Shanghai University of Sport, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siyu","family":"Guo","sequence":"additional","affiliation":[{"name":"University of Shanghai for Science and Technology, Shanghai, China"},{"name":"Department of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chuyue","family":"Gong","sequence":"additional","affiliation":[{"name":"Shanghai University of Sport, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cai","family":"Mengcheng","sequence":"additional","affiliation":[{"name":"Department of Rehabilitation Medicine, Naval Medical Center, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wei","family":"Wang","sequence":"additional","affiliation":[{"name":"Shanghai Gener Arfysica Intelligent Healthcare & Brain Science Research Institute, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hao","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Colorectal Surgery, Changhai Hospital, Naval Medical University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fanfu","family":"Fang","sequence":"additional","affiliation":[{"name":"Department of Rehabilitation Medicine, Changhai Hospital, Naval Medical University, Shanghai, China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,9,30]]},"reference":[{"key":"2025100101002272000_15.9.e103681.1","first-page":"143","article-title":"Is Unsedated Colonoscopy Gaining Ground Over Sedated Colonoscopy?","volume":"110","author":"Zhang","year":"2018","journal-title":"J Natl Med Assoc"},{"key":"2025100101002272000_15.9.e103681.2","doi-asserted-by":"crossref","first-page":"3116","DOI":"10.1007\/s10620-020-06491-0","article-title":"Unsedated Colonoscopy: 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