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Therapeutic effects and autonomic mechanisms of transcutaneous auricular vagal nerve stimulation on functional abdominal pain

Therapeutic effects of transcutaneous auricular vagal nerve stimulation on functional abdominal pain

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085697
Enrollment
Unknown
Registered
2024-06-17
Start date
2023-05-31
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

functional abdominal pain

Interventions

taVNS group:taVNS therapy is administered to every patient in the distribution area of the vagus nerve ear branch in the ear area, twice a day for one hour each time, for 14 consecutive days
sham-taVNS:Stick electrodes 5cm away from the depression of the biceps tendon at the lateral end of the elbow crease, and apply low-frequency pulse current stimulation. The stimulation parameters are

Sponsors

The Affiliated People's Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: ?18-75 years old; ? FD and IBS patients who meet the 2016 Rome IV criteria, with abdominal pain and NRS = 3 points; ? Patients who are able to independently conduct questionnaire surveys and are willing to sign informed consent forms.

Exclusion criteria

Exclusion criteria: ?Patients equipped with pacemakers; ?Patients who took anti anxiety and antidepressant drugs; ?Patients with unclear consciousness, a history of mental illness, or currently suffering from mental illness; ?Patients with diabetes and other systemic diseases that may cause abdominal pain, malignant tumor and other serious consumptive diseases; ?Patients with severe cardiovascular and liver and kidney dysfunction combined; ?Plan pregnancy, pregnant women, and lactating patients; ?Have a history of organic gastrointestinal disease or gastrointestinal surgery; ?Individuals who are allergic to skin contact; ?Patients with severe skin lesions in the ear area and absence of the earlobe.

Design outcomes

Primary

MeasureTime frame
Pain score;Heart rate variability;

Secondary

MeasureTime frame
IBS Symptom Severity;Dyspepsia Symptom;health-related quality of life;Anxiety and Depression;

Countries

China

Contacts

Public ContactLi Hongliang

The Affiliated People's Hospital of Ningbo University

1047658454@qq.com+86 138 5788 3122

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Sep 3, 2026