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

Not Applicable

Completed

• Conditions: Functional Constipation

• Registration Number: NCT03391635
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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.

Study Timeline

• Study First Submitted: 2017-12-22
• Study First Submitted QC: 2018-01-01
• Study First Posted: 2018-01-05
• Study Start: 2018-07-01
• Primary Completion: 2019-12-30
• Study Completion: 2020-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change number of average score in defecation difficulty	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
The proportion and average amount of using cathartics	weeks -1 , 4 , 8 , 20 and 32.	The proportion and average amount of using cathartics at weeks -1 , 4 , 8 , 20 and 32.
The proportion of participants with an average increasing of one or more complete spontaneous bowel movements	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.
Change number of PAC-QOL score	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.
Change number in CSBMS	Baseline，week 4，week 8, week 20 and week 32	The change in the number of CSBMs at weeks 4 , 8 , 20 and 32.
Change number in SBMS	Baseline，week 4，week 8, week 20 and week 32	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	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

Trial Locations

Locations (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences; 🇨🇳 Beijing, China