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Effect of Transcutaneous Electroacupuncture on Functional Abdominal Bloating/Distension

NCT ID: NCT04916106

Last Updated: 2021-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Functional Abdominal Bloating/Distension

Keywords

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Functional Bloating/Distension Transcutaneous electrical acupoint stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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One parameter TEA group for 4 weeks

Choose two acupoints,give 25Hz electrical stimulation for 4 weeks.

Group Type EXPERIMENTAL

Transcutaneous Electroacupuncture

Intervention Type DEVICE

give diffrent parameter TEA treatment for 4 weeks.

Another parameter TEA group for 4 weeks

Choose two acupoints,give 100 Hz electrical stimulation for 4weeks.

Group Type EXPERIMENTAL

Transcutaneous Electroacupuncture

Intervention Type DEVICE

give diffrent parameter TEA treatment for 4 weeks.

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.

Group Type EXPERIMENTAL

Transcutaneous Electroacupuncture

Intervention Type DEVICE

give diffrent parameter TEA treatment for 4 weeks.

Interventions

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Transcutaneous Electroacupuncture

give diffrent parameter TEA treatment for 4 weeks.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital of Xi'an Jiaotong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The second affiliated hospital of xi'an jiaotong university

Xi'an, Shaanxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fei Dai

Role: CONTACT

Phone: 13772151298

Email: [email protected]

Yindi Chen

Role: CONTACT

Phone: 18119487105

Email: [email protected]

Facility Contacts

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Fei Dai, MD

Role: primary

Yindi Chen

Role: backup

Other Identifiers

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S2020-YF-YBSF-0237

Identifier Type: OTHER

Identifier Source: secondary_id

2018079

Identifier Type: -

Identifier Source: org_study_id