Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome

Tongji University

Status: Completed

Conditions: Constipation-predominant Irritable Bowel Syndrome; Abdominal Pain

Treatments: Device: taVNS; Device: sham-taVNS

Study type: Interventional

Funder types: Other

Identifiers

NCT05392439

2020-006

Details and patient eligibility

About

This study aims to investigate the effects and possible mechanisms of transcutaneous auricular vagal nerve stimulation (taVNS) on abdominal pain and other symptoms in patients with IBS-C.

Full description

This study is designed as an early-feasibility, single-center, single-blinded, randomized controlled trial (RCT), in which subjects are consented, undergo a baseline assessment, and receive taVNS or sham-taVNS treatment twice a day (8 a.m. and 8 p.m.) for 30 minutes each time for a period of 4 weeks. The taVNS and sham-taVNS treatment was applied using the commercially-available Transcutaneous Electrical Applicator device (Model SNM-FDC01, Ningbo MedKinetic Medical Device Co., Ltd.) with the skin electrodes placed bilaterally on auricular concha. The patients are requested to score the abdominal pain (using VAS) and complete BSFS, IBS-SSS, IBS-QOL, SAS, and SDS forms every week and fill out the bowel diary during taVNS or sham-taVNS. Emergency medications (Macrogol 4000 and pinaverium) are permitted for use when the patient cannot tolerate symptoms of constipation and abdominal pain.

Enrollment: 42 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. willing to sign a written informed consent form
2. met the Rome IV diagnostic criteria for IBS-C

Exclusion criteria

1. history of previous abdominal surgery (other than appendectomy)
2. presence of carcinoma
3. any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, Parkinson's disease, or spinal cord injury
4. taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors
5. serious concomitant disease of the heart, liver, kidney, or diabetes
6. pregnancy or lactation
7. participating in another trial or enrolled in a trial during the past month
8. allergic reaction to surface electrodes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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42 participants in 2 patient groups

taVNS treatment

Experimental group

Description:

The taVNS treatment is performed at auricular cymba concha. The stimulation parameters are set as follows: train on-time of 2 seconds and off-time of a 3-second pulse width of 0.5 ms, pulse frequency of 25 Hz, and amplitude of 0-2 milliamp (at the maximum level tolerated by the subject).

Treatment:

Device: taVNS

sham-taVNS treatment

Sham Comparator group

Description:

Sham-taVNS is performed with the same parameters as taVNS except that electrical stimulation is applied at the elbow area.

Treatment:

Device: sham-taVNS