Evaluating pain relief during colonoscopy using electrical stimulation
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
This study is testing if a special electrical stimulation can help reduce pain for people having a colonoscopy without sedation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06813703 on ClinicalTrials.gov |
What this trial studies
This study is a randomized controlled trial that investigates the analgesic effects of Transcutaneous Electrical Nerve Stimulation based on Wrist-Ankle Acupuncture (TENS-WAA) during unsedated colonoscopy. It involves 60 patients aged 18-75 with stable cardiopulmonary function and low baseline pain scores. Participants will be randomly assigned to receive either TENS stimulation or a sham treatment before the procedure, while their brain activity will be monitored using EEG-fNIRS technology to assess pain perception. The goal is to understand how TENS-WAA can alleviate pain during this procedure.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are undergoing unsedated colonoscopy and have stable cardiopulmonary function.
Not a fit: Patients with cognitive impairments, active infections, or those who have recently used sedatives or analgesics may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive method to reduce pain during colonoscopy, improving patient comfort and experience.
How similar studies have performed: While the specific combination of TENS-WAA and EEG-fNIRS is novel, similar studies using TENS for pain management have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- The First Affiliated Hospital of Naval Medical University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Xiaonan Huang, master
- Email: 1301090492@qq.com
- Phone: 86+15700719913
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.