- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05392439
Effect of taVNS on Abdominal Pain and Other Symptoms in Constipation-predominant Irritable Bowel Syndrome
May 25, 2022 updated by: Xiaodan Shi, Tongji University
The Efficacy and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Abdominal Pain and Other Symptoms in Patients With Constipation-predominant Irritable Bowel Syndrome
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Shanghai, China, 200120
- Shanghai East Hospital, Tongji University School of Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- willing to sign a written informed consent form
- met the Rome IV diagnostic criteria for IBS-C
Exclusion Criteria:
- history of previous abdominal surgery (other than appendectomy)
- presence of carcinoma
- any organic diseases causing constipation or neurologic diseases such as multiple sclerosis, rachischisis, Parkinson's disease, or spinal cord injury
- taking antidepressant agents including tricyclic antidepressants and selective serotonin reuptake inhibitors
- serious concomitant disease of the heart, liver, kidney, or diabetes
- pregnancy or lactation
- participating in another trial or enrolled in a trial during the past month
- allergic reaction to surface electrodes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: taVNS treatment
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).
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transcutaneous auricular vagal nerve stimulation
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Sham Comparator: sham-taVNS treatment
Sham-taVNS is performed with the same parameters as taVNS except that electrical stimulation is applied at the elbow area.
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transcutaneous stimulation at the elbow area
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in аbdominal pain between sham and active taVNS
Time Frame: 4 weeks
|
Weekly average of daily patient-assessed abdominal pain using the visual analog scale (VAS).
VAS ranges from 0 to 10, with 0 indicating no abdominal pain and 10 indicating the maximal pain.
Efficacy is evaluated as an improvement of ≥ 30%.
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4 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in IBS symptom severity scale (IBS-SSS) between sham and active taVNS
Time Frame: 4 weeks
|
Questionnaire consists of 5 questions (abdominal pain intensity, abdominal pain frequency, abdominal distension degree, defecation satisfaction, and interference with quality of life), with a total score of 500 points and a higher score indicating a worse condition.
Scores < 175 represent mild IBS symptoms, scores 175-300 represent moderate severity, and scores > 300 represent severe IBS.
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4 weeks
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Change in IBS quality of life (IBS-QOL) between sham and active taVNS
Time Frame: 4 weeks
|
Questionnaire is composed of 8 dimensions (dysphoria, interference with activity, body image, health concerns, food avoidance, social reaction, sex, and relationships), with 34 items assessing the degree to which IBS interferes with the patient's quality of life.
Each item is evaluated on a 5-point Likert scale.
The total score ranges from 34 to 170 and higher scores indicate better quality of life.
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4 weeks
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Change in Bristol stool form scale (BSFS) between sham and active taVNS
Time Frame: 4 weeks
|
The scale has 7 points according to stool type, from the hardest (1) to the softest (7).
The lower the score, the more severe is constipation.
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4 weeks
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Change in Self-Rating Anxiety Scale (SAS) score between sham and active taVNS
Time Frame: 4 weeks
|
SAS questionnaire has 20 items to assess physical and psychological symptoms, using a 4-point Likert scale ranging from 1 (none, or a little of the time) to 4 (most, or all of the time), with a total score ranging from 20 to 80. SAS scores below 50 indicate no anxiety, from 50 to 59 - mild anxiety, from 60 to 69 - moderate anxiety, 70 and above - severe anxiety.
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4 weeks
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Change in Self-Rating Depression Scale (SDS) score between sham and active taVNS
Time Frame: 4 weeks
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SDS questionnaire has 20 items to assess physical and psychological symptoms, using a 4-point Likert scale ranging from 1 (none, or a little of the time) to 4 (most, or all of the time), with a total score ranging from 20 to 80. SDS scores below 50 indicate no depression, from 50 to 59 - mild depression, from 60 to 69 - moderate depression, 70 and above - severe depression.
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4 weeks
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Change in complete spontaneous bowel movements per week between sham and active taVNS
Time Frame: 4 weeks
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Number of bowel movements that occur without use of any medication or other methods to assist defecation and with a feeling of complete evacuation
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4 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in autonomic function assessed by the spectral parameters of heart rate variability between sham and active stimulation
Time Frame: 4 weeks
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Heart rate variability parameters are calculated using spectral analysis of R-R intervals in electrocardiogram (ECG)
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4 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Actual)
December 15, 2020
Study Completion (Actual)
December 15, 2020
Study Registration Dates
First Submitted
May 21, 2022
First Submitted That Met QC Criteria
May 24, 2022
First Posted (Actual)
May 26, 2022
Study Record Updates
Last Update Posted (Actual)
May 31, 2022
Last Update Submitted That Met QC Criteria
May 25, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-006
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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