NCT06813703

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Colonoscopy
• Pain

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2025-02-18
• Primary completion: 2025-08-30
• Completion: 2026-02-15
• First posted: 2025-02-07
• Last updated: 2025-08-08

Locations

1 site across 1 country: China