Effect of Transcutaneous Electroacupuncture on Functional Abdominal Bloating/Distension

Effect of Transcutaneous Electroacupuncture on Patients With Functional Abdominal Bloating/Distension

Functional abdominal bloating/distension (FAB/D) is a common functional bowel disorder that lacks effective treatment options. Transcutaneous electroacupuncture (TEA) as a new therapeutic method has great effect on functional gastrointestinal diseases such as functional dyspepsia and functional constipation. Research on TEA for FAB/D has not yet been explored.

Study Overview

• Status: Recruiting
• Conditions: Functional Abdominal Bloating/Distension
• Intervention / Treatment: Device: Transcutaneous Electroacupuncture

Detailed Description

Functional abdominal bloating/distension (FAB/D) is a common functional bowel disorder that lacks effective treatment options. Rome IV was introduced in 2016. Studies have shown that bloating may affect about 30% general population and 96% of patients with functional gastrointestinal disorders (FGID).Transcutaneous electroacupuncture (TEA) as a new therapeutic method has great effect on functional gastrointestinal diseases such as functional dyspepsia and functional constipation. Research on TEA for FAB/D has not yet been explored. Thirty patients who fulfilled the Rome IV diagnostic criteria of FAB/D in the department of the second affiliated hospital of Xi'an jiaotong University.Inclusion criteria included: Symptoms of recurrent abdominal fullness, pressure, or a sensation of trapped gas (bloating), and/or measurable (objective) increase in abdominal girth (distention) more than 6 month；the main symptoms appeared in the past 3 months；Not taking related drugs; aged 18-65 years old；From January 2020 to December 2021; Sign informed consent. All patients were randomly assigned to 3 groups and received TEA at Zusanli (ST36) and Neiguan (PC6) with 3 diffrent parameter for 4weeks. The symptom severity score, abdominal girth, electrogastrogram (ECG) and orocecal transit time (OCTT) ,heart rate variability (HRV) ,rectal sensitivity and intestinal flora were recorded at baseline and after 2-week treatment, respectively. The symptom severity score was repeated at baseline and after 4-week treatment. Through the comparison of the index before and after TEA treatment to identify optimal stimulation parameters and explore its possible mechanism. The study was proved by the medical ethics committee of the Second Affiliated Hospital of Xi'an jiaotong University.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fei Dai; Phone Number: 13772151298; Email: daifei68@hotmail.com
• Study Contact Backup: Name: Yindi Chen; Phone Number: 18119487105; Email: daifei68@hotmail.com

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • Recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Fei Dai, MD; Phone Number: 13772151298; Email: daifei68@hotmail.com
      • Contact: Yindi Chen; Phone Number: 18119487105; Email: 593825787@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Clinical diagnosis of Functional bloating/distension with Rome IV;
2. Aged 18-65 years old；

Exclusion Criteria:

1. Have taken drugs that may affect gastrointestinal motility in the past week;
2. Have taken antibiotics and probiotics in the past month;
3. The history of gastrointestinal surgery;
4. Helicobacter pylori is not cleared；
5. Pregnant and breastfeeding women;
6. Skin allergies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: One parameter TEA group for 4 weeks; Choose two acupoints,give 25Hz electrical stimulation for 4 weeks.	Device: Transcutaneous Electroacupuncture; give diffrent parameter TEA treatment for 4 weeks.
Experimental: Another parameter TEA group for 4 weeks; Choose two acupoints,give 100 Hz electrical stimulation for 4weeks.	Device: Transcutaneous Electroacupuncture; give diffrent parameter TEA treatment for 4 weeks.
Experimental: Sham-TEA group for 2 weeks, and the random TEA for the next 2 weeks.; Choose two non-acupoints，give 25Hz and 100Hz electroacupuncture stimulation respectively for the first 2 weeks. Then give supplement TEA treatment as described above for the next 2 weeks.	Device: Transcutaneous Electroacupuncture; give diffrent parameter TEA treatment for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom improvement rate	the symptom severity score with VAS and abdominal girth measurements	after 1 month TEA treatment
The percentage of the normal gastric slow waves in electrogastrograph	The percentage of the normal gastric slow waves in fasting 、fed states and the post-preprandial EGG power ratio	after 1 month TEA treatment
Orocecal ransit time	the lactulose hydrogen breath test was used to evaluate the intestinal transit time and observe the presence or absence of excessive small intestinal bacteria	after 1-month TEA treatment
Heart rate variability（HRV）	Assessment of autonomic function with heart rate variability	after 1-month TEA treatment
Flora structure	an Illumina MiSeq Platform was used to sequence 16S ribosomal RNA (rRNA) gene of the total bacteria in fecal samples.	after 1-month TEA treatment
Rectal sensitivity	Rectal threshold for gas and defecation	after 1-month TEA treatment
Plasma gastrointestinal peptide level	CCK、SP、NPY、CGRP、Motilin	after 1-month TEA treatment

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Xi'an Jiaotong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): November 26, 2021
• Last Update Submitted That Met QC Criteria: November 16, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Functional Bloating/Distension; Transcutaneous electrical acupoint stimulation
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Dilatation, Pathologic
• Other Study ID Numbers: 2018079; S2020-YF-YBSF-0237 (Other Identifier: Shaanxi Provincial Health and Family Planning Commission)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No