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

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

Detailed Description
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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.

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

Conditions
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Functional Constipation

Intervention / Treatment
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* Device: Electroacupuncture
* Device: TranscutaneousElectricNerveStimulation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture<br>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<br>* Participants will receive electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.<br>* Other names: EA;|
| Active Comparator: TranscutaneousElectricNerveStimulation<br>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<br>* 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.<br>* Other names: TENS;|

What is the study measuring?
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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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | The proportion and average amount of using cathartics at weeks -1 , 4 , 8 , 20 and 32. | weeks -1 , 4 , 8 , 20 and 32. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acupuncture, functional constipation, transcutaneous electric nerve stimulation, randomized controlled trial