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

Primary Purpose

Functional Constipation

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Electroacupuncture

TranscutaneousElectricNerveStimulation

About this trial

This is an interventional treatment trial for Functional Constipation focused on measuring acupuncture, functional constipation, transcutaneous electric nerve stimulation, randomized controlled trial

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Conforming to the criteria for the diagnosis of functional constipation in Rome III standard;
Aged of 18 to 75 years;
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:

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

Sites / Locations

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Electroacupuncture

TranscutaneousElectricNerveStimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.

Secondary Outcome Measures

The proportion of participants with an average increasing of one or more complete spontaneous bowel movements

The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at weeks 4 , 20 and 32.

Change number in CSBMS

The change in the number of CSBMs at weeks 4 , 8 , 20 and 32.

Change number in SBMS

The change in the number of SBMs at weeks 4 , 8 , 20 and 32.

The proportion of participants with type3 or type 4 stool character

According to the BRISTOL stool form scale, the proportion of participants with type3 or type 4 at weeks 4 , 8 , 20 and 32

Change number of average score in defecation difficulty

The change in average score of difficulty in defecation at weeks 4 , 8 , 20 and 32

Change number of PAC-QOL score

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.

The proportion and average amount of using cathartics

The proportion and average amount of using cathartics at weeks -1 , 4 , 8 , 20 and 32.

Full Information

NCT ID

NCT03391635

First Posted

December 22, 2017

Last Updated

March 14, 2022

Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT03391635

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

July 1, 2018 (Actual)

Primary Completion Date

December 30, 2019 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Functional Constipation

Keywords

acupuncture, functional constipation, transcutaneous electric nerve stimulation, randomized controlled trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Electroacupuncture

Arm Type

Experimental

Arm Description

Arm Title

TranscutaneousElectricNerveStimulation

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Electroacupuncture

Other Intervention Name(s)

Intervention Description

Participants will receive electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.

Intervention Type

Device

Intervention Name(s)

TranscutaneousElectricNerveStimulation

Other Intervention Name(s)

TENS

Intervention Description

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.

Primary Outcome Measure Information:

Title

The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.

Description

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

Secondary Outcome Measure Information:

Title

The proportion of participants with an average increasing of one or more complete spontaneous bowel movements

Description

The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at weeks 4 , 20 and 32.

Time Frame

Baseline，week 4，week 20 and week 32

Title

Change number in CSBMS

Description

The change in the number of CSBMs at weeks 4 , 8 , 20 and 32.

Time Frame

Baseline，week 4，week 8, week 20 and week 32

Title

Change number in SBMS

Description

The change in the number of SBMs at weeks 4 , 8 , 20 and 32.

Time Frame

Baseline，week 4，week 8, week 20 and week 32

Title

The proportion of participants with type3 or type 4 stool character

Description

According to the BRISTOL stool form scale, the proportion of participants with type3 or type 4 at weeks 4 , 8 , 20 and 32

Time Frame

Baseline，week 4，week 8, week 20 and week 32

Title

Change number of average score in defecation difficulty

Description

The change in average score of difficulty in defecation at weeks 4 , 8 , 20 and 32

Time Frame

Baseline，week 4，week 8, week 20 and week 32

Title

Change number of PAC-QOL score

Description

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.

Time Frame

Baseline，week 8

Title

The proportion and average amount of using cathartics

Description

The proportion and average amount of using cathartics at weeks -1 , 4 , 8 , 20 and 32.

Time Frame

weeks -1 , 4 , 8 , 20 and 32.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Conforming to the criteria for the diagnosis of functional constipation in Rome III standard; Aged of 18 to 75 years; 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: Constipation caused by irritable bowel syndrome and organically or medicated; secondary to endocrine, metabolic, neurogenic, or surgical constipation; Subjects with serious heart, liver, kidney damage or cognitive impairment, aphasia, mental disorders, or the inability to cooperate with the examination and treatment. Pregnant or lactation patients; Subjects with abdominal aortic aneurysm, abnormal enlargement of liver and spleen and so on. Subjects with coagulation dysfunction or anticoagulants such as warfarin and heparin have been used all the time. Subjects installed with the cardiac pacemaker.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yuxiao Zeng

Organizational Affiliation

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

City

Beijing

ZIP/Postal Code

100053

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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

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