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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- EEG-fNIRS Neurovascular Coupling Peak β Coefficient
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Before the trial begins, envelopes containing sequentially numbered cards from 1 to 60 will be prepared to determine participant allocation. The coordinator will open the envelopes in the order of participant enrollment. Throughout the trial, researchers are not allowed to alter the enrollment sequence. Participants will be informed in advance that they may experience electrical stimulation sensations, and communication between participants will be prohibited during the entire trial process. The statistician responsible for data analysis will remain blinded to the group allocation of participants.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
control group
Participants in the control group will have the electrodes placed in the same positions as those in the stimulation group, with identical electrical stimulation frequency and pulse width settings. However, the current intensity will be set to the minimum level.
干预措施: Using an electrical stimulation device to relieve pain during colonoscopy (Device)
Electrical stimulation group
According to the WAA theory, the selected Lower Zone 1 (LZ1) and Lower Zone 2 (LZ2) are defined as follows: LZ1 is located between the medial Achilles tendon and the medial malleolus, while LZ2 is positioned at the central inner edge of the ankle joint, near the posterior border of the tibia. Two electrode pads will be placed on each LZ1 and LZ2 of both legs, totaling eight electrode pads. The TENS-WAA device will be set to a frequency of 2 Hz, a pulse width of 500 μs, and a continuous waveform. Participants in the stimulation group will receive electrical currents at their maximum tolerable intensity below the pain threshold.
干预措施: Using an electrical stimulation device to relieve pain during colonoscopy (Device)
结局指标
主要结局
EEG-fNIRS Neurovascular Coupling Peak β Coefficient
时间窗: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified analysis window for each stage.
Neurovascular coupling is quantified from synchronized electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) recordings. EEG activity is decomposed into predefined delta, theta, alpha, and beta frequency bands, and band-specific power envelopes are coupled with fNIRS-derived oxygenated haemoglobin (HbO) signals within predefined cortical regions of interest. A 10-second lag is applied to account for the delayed haemodynamic response following neural activity. Coupling is estimated using a general linear model. The peak β coefficient within the predefined analysis window is used to quantify maximum EEG-fNIRS neurovascular coupling strength. Values are calculated separately for the predefined frequency bands and cortical regions of interest and compared between the distal transcutaneous electrical nerve stimulation and sham stimulation groups.
EEG-fNIRS Neurovascular Coupling β Area Under the Curve
时间窗: During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified analysis window for each stage.
Neurovascular coupling is quantified from synchronized electroencephalography (EEG) and functional near-infrared spectroscopy (fNIRS) recordings. EEG activity is decomposed into predefined delta, theta, alpha, and beta frequency bands, and band-specific power envelopes are coupled with fNIRS-derived oxygenated haemoglobin (HbO) signals within predefined cortical regions of interest. A 10-second lag is applied to account for the delayed haemodynamic response following neural activity. Coupling is estimated using a general linear model. The area under the β-coefficient curve (β AUC) within the predefined analysis window is used to quantify cumulative EEG-fNIRS neurovascular coupling strength over time. Values are calculated separately for the predefined frequency bands and cortical regions of interest and compared between the distal transcutaneous electrical nerve stimulation and sham stimulation groups.
次要结局
- Pain VAS score(During colonoscopy, when the endoscope passes through the rectosigmoid junction, splenic flexure, and hepatic flexure.)
- EEG-Derived Cortical Neural Activity(During colonoscopy at predefined procedural stages, including anal intubation, splenic flexure, hepatic flexure, and ileocecal valve.)
- fNIRS-Derived HbO Cortical Activation(During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified post-event analysis window for each stage.)
- fNIRS-Derived HbR Cortical Activation(During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation, within the prespecified post-event analysis window for each stage.)
- fNIRS-Derived Cortical Functional Connectivity(During colonoscopy, at predefined procedural stages including anal intubation, splenic flexure, hepatic flexure, and cecal intubation.)
- Colonoscopy time(during procedure (The total time to reach the three bends and to the ileocecal valve and for the entire examination was recorded))
研究者
Xiaonan Huang
Clinical Professor
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University