Clinical trial
Effect of Transcutaneous Auricular Vagal Nerve Stimulation on Chronic Constipation: A Randomized Controlled Trial
Name
KY20222075-F-1
Description
The worldwide prevalence of chronic constipation (CC) is 15%, and women are more likely to develop the disease than men. CC have a significant impact on quality of life and increase the burden of national health insurance. The conventional medication treatments are primarily symptom-specific and have limited efficacy. Previous small sample study had shown the therapeutic potential of transcutaneous auricular vagus nerve stimulation (taVNS) for irritable bowel syndrome with constipation (IBS-C). The aim of this study was to investigate whether taVNS could improve defecation condition and constipation symptoms in patients with CC.
Trial arms
Trial start
2023-01-03
Estimated PCD
2024-01-31
Trial end
2024-02-28
Status
Recruiting
Treatment
taVNS
Patients will receive taVNS (device produced by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s "on" periods and 30s "off" periods; frequency: 25 Hz; amplitude of 0-2 mA at the maximum level that the patient could tolerate; pulse width: 0.5ms)
Arms:
Sham-treatment group, Treatment group
Laxative Agent
Bisacodyl or glycerin enemas can be used in patients who do not have a bowel movement for more than 3 days.
Arms:
Sham-treatment group, Treatment group
Size
210
Primary endpoint
Responder rate
4 weeks
Eligibility criteria
Inclusion Criteria:
1. FC or IBS-C patients aged 18-75 years who meet the diagnostic criteria for Rome IV;
2. Complete spontaneous bowel movements (CSBMs) per week \< 3;
3. No constipation medication used for at least 2 weeks prior to enrollment, not participated in clinical trials in the past three months, and no abnormal colonoscopy within the past 12 months in those with alarm symptoms.
Exclusion Criteria:
1. Have cognitive impairment, psychiatric disorders, or conditions that may affect patient cooperation;
2. Have a cardiac pacemaker implantation or other electronically implanted devices;
3. Prior taVNS treatment;
4. History of colorectal surgery, except for simple appendectomy;
5. Severe cardiovascular, hepatic, or renal disease;
6. Known malignancy;
7. Secondary constipation caused by medications and other diseases;
8. Pregnant or lactating women;
9. Refusal to sign an informed consent.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 210, 'type': 'ESTIMATED'}}
Updated at
2023-02-13
1 organization
Organization
Air Force Military Medical University