Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation

March 14, 2022 updated by: Yuxiao Zeng, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation:a Randomized Controlled Trial

The objective of this trial is to compare the efficacy of electroacupuncture versus transcutaneous electric nerve stimulation for functional constipation

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Both electroacupuncture(EA) therapy and transcutaneous electric nerve stimulation(TENS) are safe and effective for functional constipation, but no head to head comparing trial was conducted.

Methods：102 participants with functional constipation will be recruited and randomly allocated into the EA group and the TENS group.Participants in both groups will receive EA or TENS treatment at Tianshu(ST 25), Fujie(SP 14) and Shangju xu(ST 37) 3 times a week for 8 weeks.

Study Type

Interventional

Enrollment (Actual)

70

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

  • China
      • Beijing, China, 100053
        • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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:

  1. Conforming to the criteria for the diagnosis of functional constipation in Rome III standard;
  2. Aged of 18 to 75 years;
  3. No medication for constipation has been used for at least 2 weeks before treatment. Except for emergency treatment, it has not received acupuncture treatment for constipation in the past 3 months, and has not participated in other ongoing clinical research.

Exclusion Criteria:

  1. Constipation caused by irritable bowel syndrome and organically or medicated; secondary to endocrine, metabolic, neurogenic, or surgical constipation;
  2. Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment.
  3. Pregnant or lactation patients;
  4. Subjects with abdominal aortic aneurysm, abnormal enlargement of liver and spleen and so on.
  5. Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time.
  6. Subjects installed with the cardiac pacemaker.

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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Electroacupuncture

The treatment consists of 3 times a week for 8 weeks.Huatuo Brand needles (0.30×50mm or 0.30×70mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used for ST25, SP14 and ST37.After acupuncture，the needle handle will be connected with the electrode in the electroacupuncture instrument.

The parameters of the electric acupuncture apparatus：Dilatational wave，the frequency is 2/10Hz，the electric current intensity is 0.1mA-1.0mA.
Device: Electroacupuncture
Participants will receive electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
Other Names:
  • EA
Active Comparator: TranscutaneousElectricNerveStimulation

The treatment consists of 3 times a week for 8 weeks.Huatuo Brand electrode patch (50mm×50mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used for ST25, SP14 and ST37.

The parameters of the electric acupuncture apparatus：Dilatational wave，the frequency is 2/10Hz，the electric current intensity is 2mA-5mA.
Device: TranscutaneousElectricNerveStimulation
Participants will receive transcutaneous electric nerve stimulation at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
Other Names:
  • TENS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.
Time Frame: Baseline，week 8
The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.
Baseline，week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The proportion of participants with an average increasing of one or more complete spontaneous bowel movements
Time Frame: Baseline，week 4，week 20 and week 32
The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at weeks 4 , 20 and 32.
Baseline，week 4，week 20 and week 32
Change number in CSBMS
Time Frame: Baseline，week 4，week 8, week 20 and week 32
The change in the number of CSBMs at weeks 4 , 8 , 20 and 32.
Baseline，week 4，week 8, week 20 and week 32
Change number in SBMS
Time Frame: Baseline，week 4，week 8, week 20 and week 32
The change in the number of SBMs at weeks 4 , 8 , 20 and 32.
Baseline，week 4，week 8, week 20 and week 32
The proportion of participants with type3 or type 4 stool character
Time Frame: Baseline，week 4，week 8, week 20 and week 32
According to the BRISTOL stool form scale, the proportion of participants with type3 or type 4 at weeks 4 , 8 , 20 and 32
Baseline，week 4，week 8, week 20 and week 32
Change number of average score in defecation difficulty
Time Frame: Baseline，week 4，week 8, week 20 and week 32
The change in average score of difficulty in defecation at weeks 4 , 8 , 20 and 32
Baseline，week 4，week 8, week 20 and week 32
Change number of PAC-QOL score
Time Frame: Baseline，week 8
The change in total score on the patients assessment of constipation quality of life questionnaire(PAC-QOL) total score at the end of week 8, compared with baseline.
Baseline，week 8
The proportion and average amount of using cathartics
Time Frame: weeks -1 , 4 , 8 , 20 and 32.
The proportion and average amount of using cathartics at weeks -1 , 4 , 8 , 20 and 32.
weeks -1 , 4 , 8 , 20 and 32.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Investigators

  • Principal Investigator: Yuxiao Zeng, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

General Publications

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)

July 1, 2018

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

December 30, 2020

Study Registration Dates

First Submitted

December 22, 2017

First Submitted That Met QC Criteria

January 1, 2018

First Posted (Actual)

January 5, 2018

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAMHospital20171222

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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