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Completed

NCT Number: NCT05392439

Effect of taVNS on Abdominal Pain and Other Symptoms in 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.

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Key information

Conditions

Constipation-predominant Irritable Bowel Syndrome Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai East Hospital, Tongji University School of Medicine

Shanghai, 200120, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

taVNS

Device

transcutaneous auricular vagal nerve stimulation

sham-taVNS

Device

transcutaneous stimulation at the elbow area

Primary outcomes

  1. 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%.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Change in Self-Rating Depression Scale (SDS) score between sham and active taVNS

    Time frame: 4 weeks

    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.

  6. Change in complete spontaneous bowel movements per week between sham and active taVNS

    Time frame: 4 weeks

    Number of bowel movements that occur without use of any medication or other methods to assist defecation and with a feeling of complete evacuation

Other outcomes

  1. Change in autonomic function assessed by the spectral parameters of heart rate variability between sham and active stimulation

    Time frame: 4 weeks

    Heart rate variability parameters are calculated using spectral analysis of R-R intervals in electrocardiogram (ECG)

Sponsors and collaborators

Lead sponsor

Tongji University

Other

Collaborators

  • Shanghai East Hospital

Registry information

Official study title

The Efficacy and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation on Abdominal Pain and Other Symptoms in Patients With Constipation-predominant Irritable Bowel Syndrome

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 26, 2022
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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