Analysis of the Analgesic Mechanism of TENS-WAA During Non-anesthetized Colonoscopy Using EEG-fNIRS System

Официальное название

Analysis of the Analgesic Mechanism of Transcutaneous Electrical Nerve Stimulation Based on Wrist-ankle Acupuncture Theory During Non-anesthetized Colonoscopy Using Electroencephalogram-Functional Infrared Spectroscopy System

Обзор

This study is a single-center, randomized controlled trial aiming to evaluate the analgesic mechanism of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture (TENS-WAA) during unsedated colonoscopy using EEG-fNIRS technology to assess neural activity in brain regions associated with pain perception. Sixty patients aged 18-75 years, with stable cardiopulmonary function and a baseline visual analog scale (VAS) pain score \<3, will be enrolled and randomly allocated into the intervention and control groups. The intervention group will receive TENS stimulation based on the Wrist-Ankle Acupuncture theory 10 minutes before the colonoscopy, with a frequency of 2 Hz and adjustable current intensity ranging from 1 to 9 mA. The control group will receive minimal-intensity sham stimulation under identical conditions. All participants will wear EEG-fNIRS devices to monitor neural activity in key pain-related brain areas, including the prefrontal cortex, anterior cingulate cortex, motor cortex, and parietal cortex. Primary outcomes include EEG-fNIRS data, while secondary outcomes are VAS scores at the four colonic bends, colonoscopy duration, and the correlation between EEG-fNIRS signals and pain perception. Statistical analyses will include multivariable linear regression, generalized estimating equations, and mixed-effects models to investigate the analgesic effects and neural mechanisms of TENS-WAA. This study seeks to provide innovative pain management strategies for patients undergoing unsedated colonoscopy and further explore the neuroregulatory potential of TENS-WAA technology.

Вмешательства

• Устройство Using an electrical stimulation device to relieve pain during colonoscopy
  In the electrical stimulation group, the device's current intensity will be adjusted to the maximum tolerance below the participant's pain threshold, while in the control group, the current intensity will be set to the minimum.

Первичные конечные точки

• NeuroActivity Correlation Index [Срок оценки: during procedure]

Вторичные конечные точки (3)

• Pain VAS score [Срок оценки: during procedure (When the endoscope passes through the hepatic flexure, splenic area and rectosigmoid junction)]
• Colonoscopy time [Срок оценки: during procedure (The total time to reach the three bends and to the ileocecal valve and for the entire examination was recorded)]
• Correlation between EEG-fNIRS and pain VAS scores [Срок оценки: up to 24 weeks]

Критерии участия

• Inclusion Criteria:

• Patients undergoing unsedated colonoscopy are eligible for inclusion in this study.
• Aged 18 to 75 years.
• Meeting the requirements for colonoscopy, with good cardiopulmonary function and stable vital signs.
• A pre-procedural Visual Analog Scale (VAS) pain score of less than 3.
• Exclusion Criteria:

• Participants with speech or cognitive impairments.
• Those with acute anal or rectal stenosis, acute perianal or rectal infections, acute diverticulitis, or active inflammatory bowel disease.
• Women who are menstruating, pregnant, or breastfeeding.
• Patients with active tuberculosis, hemophilia, or advanced malignant tumors.
• Individuals with sensory disturbances, implanted pacemakers or defibrillators, or ankle skin ulcers.
• Those who have used sedatives or analgesics either long-term or within the past 24 hours.
• Individuals with any condition that interferes with EEG-fNIRS signal acquisition, such as cranial abnormalities, implanted metal or electronic devices, epilepsy, or neurological disorders.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of Naval Medical University — Шанхай

Публикации

• Wang H, Huang X, Xu L, Guo S, Gong C, Mengcheng C, Wang W, Wang H, Fang F. Analysis of the analgesic mechanism of TENS-WAA in colonoscopy using the EEG-fNIRS system: a study protocol for a randomised controlled trial. BMJ Open. 2025 Sep 30;15(9):e103681. doi: 10.1136/bmjopen-2025-103681. PMID 41033775

Идентификаторы

NCT: NCT06813703 · CHEC2025-006

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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