About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Using an electrical stimulation device to relieve pain during colonoscopy
Treatment groups
Sponsors and collaborators
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University
Lead sponsor
Shanghai Shuli Intelligent Technology Co., Ltd
Collaborator