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

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Status: Completed

Conditions: Functional Constipation

Treatments: Device: TranscutaneousElectricNerveStimulation; Device: Electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03391635

GAMHospital20171222

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Electroacupuncture

Experimental group

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.

Treatment:

Device: Electroacupuncture

TranscutaneousElectricNerveStimulation

Active Comparator group

Description:

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.

Treatment:

Device: TranscutaneousElectricNerveStimulation