Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation
NCT ID: NCT03391635
Last Updated: 2022-03-16
Study Results
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Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2018-07-01
2020-12-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Electroacupuncture
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.
Electroacupuncture
Participants will receive electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
TranscutaneousElectricNerveStimulation
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.
TranscutaneousElectricNerveStimulation
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.
Interventions
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Electroacupuncture
Participants will receive electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
TranscutaneousElectricNerveStimulation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Yuxiao Zeng
Postgraduate student of China Academy of Chinese Medical Sciences
Principal Investigators
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Yuxiao Zeng
Role: PRINCIPAL_INVESTIGATOR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Locations
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, , China
Countries
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References
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Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011 Feb;25(1):3-18. doi: 10.1016/j.bpg.2010.12.010.
Tran LC, Di Palma JA. Lack of lasting effectiveness of PEG 3350 laxative treatment of constipation. J Clin Gastroenterol. 2005 Aug;39(7):600-2. doi: 10.1097/01.mcg.0000170769.67320.47.
Gordon M, Naidoo K, Akobeng AK, Thomas AG. Osmotic and stimulant laxatives for the management of childhood constipation. Cochrane Database Syst Rev. 2012 Jul 11;(7):CD009118. doi: 10.1002/14651858.CD009118.pub2.
Pare P, Bridges R, Champion MC, Ganguli SC, Gray JR, Irvine EJ, Plourde V, Poitras P, Turnbull GK, Moayyedi P, Flook N, Collins SM. Recommendations on chronic constipation (including constipation associated with irritable bowel syndrome) treatment. Can J Gastroenterol. 2007 Apr;21 Suppl B(Suppl B):3B-22B.
Ford AC, Suares NC. Effect of laxatives and pharmacological therapies in chronic idiopathic constipation: systematic review and meta-analysis. Gut. 2011 Feb;60(2):209-18. doi: 10.1136/gut.2010.227132.
Wong SW, Lubowski DZ. Slow-transit constipation: evaluation and treatment. ANZ J Surg. 2007 May;77(5):320-8. doi: 10.1111/j.1445-2197.2007.04051.x.
Pfeifer J. Surgical options to treat constipation: A brief overview. Rozhl Chir. 2015 Sep;94(9):349-61.
Remes Troche JM, Gomez Escudero O, Icaza Chavez ME, Noble Lugo A, Lopez Colombo A, Bielsa MV, Charua Guindic L; Asociacion Mexicana de Gastroenterologia. [Guidelines for diagnosis and treatment of constipation in Mexico. C) Medical and surgical treatment]. Rev Gastroenterol Mex. 2011 Apr-Jun;76(2):141-54. Spanish.
Du WF, Yu L, Yan XK, Wang FC. [Met-analysis on randomized controlled clinical trials of acupuncture and moxibustion on constipation]. Zhongguo Zhen Jiu. 2012 Jan;32(1):92-6. Chinese.
Liu Z, Yan S, Wu J, He L, Li N, Dong G, Fang J, Fu W, Fu L, Sun J, Wang L, Wang S, Yang J, Zhang H, Zhang J, Zhao J, Zhou W, Zhou Z, Ai Y, Zhou K, Liu J, Xu H, Cai Y, Liu B. Acupuncture for Chronic Severe Functional Constipation: A Randomized Trial. Ann Intern Med. 2016 Dec 6;165(11):761-769. doi: 10.7326/M15-3118. Epub 2016 Sep 13.
Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. doi: 10.1053/j.gastro.2006.03.008. No abstract available.
Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005 May;40(5):540-51. doi: 10.1080/00365520510012208.
Yang X, Liu Y, Liu B, He L, Liu Z, Yan Y, Liu J, Liu B. Factors related to acupuncture response in patients with chronic severe functional constipation: Secondary analysis of a randomized controlled trial. PLoS One. 2017 Nov 22;12(11):e0187723. doi: 10.1371/journal.pone.0187723. eCollection 2017.
Ismail KA, Chase J, Gibb S, Clarke M, Catto-Smith AG, Robertson VJ, Hutson JM, Southwell BR. Daily transabdominal electrical stimulation at home increased defecation in children with slow-transit constipation: a pilot study. J Pediatr Surg. 2009 Dec;44(12):2388-92. doi: 10.1016/j.jpedsurg.2009.07.063.
Clarke MC, Chase JW, Gibb S, Hutson JM, Southwell BR. Improvement of quality of life in children with slow transit constipation after treatment with transcutaneous electrical stimulation. J Pediatr Surg. 2009 Jun;44(6):1268-72; discussion 1272. doi: 10.1016/j.jpedsurg.2009.02.031.
Other Identifiers
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GAMHospital20171222
Identifier Type: -
Identifier Source: org_study_id
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