An interventional study of Electroacupuncture and TranscutaneousElectricNerveStimulation in Functional Constipation, sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-03-16.
Sponsored by Guang'anmen Hospital of China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
The objective of this trial is to compare the efficacy of electroacupuncture versus transcutaneous electric nerve stimulation for functional constipation
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.
Exclusion Criteria:
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
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 electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
Also known as: EA
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.
Also known as: TENS
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.
Time frame: Baseline，week 8
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: weeks -1 , 4 , 8 , 20 and 32.
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences