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

Launched by FIRST AFFILIATED HOSPITAL OF THE CHINESE PEOPLE'S LIBERATION ARMY NAVAL MEDICAL UNIVERSITY · Feb 6, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a method called Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture (TENS-WAA) to help manage pain during unsedated colonoscopy procedures. The researchers want to understand how this technique affects the brain's response to pain by using special devices that monitor brain activity. They will recruit 60 participants aged between 18 and 75 years who are in good health and have a low pain level before the procedure. Eligible participants must not have certain medical conditions, like active infections or neurological disorders, that could interfere with the study.

If you join this trial, you will be randomly placed into one of two groups. One group will receive the TENS treatment just before the colonoscopy, while the other group will receive a similar, but less intense, treatment. Throughout the procedure, both groups will wear devices to track brain activity related to pain. The goal is to find new ways to manage pain for patients undergoing this kind of procedure without sedation and to learn more about how TENS-WAA works in the brain.

Gender

ALL

Eligibility criteria

• 1. 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.
• 2. 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.