Clinical trial NCT03391635: Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation
Official title: Efficacy of Electroacupuncture Compared With Transcutaneous Electric Nerve Stimulation for Functional Constipation:a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Constipation
Keywords: acupuncture
functional constipation
transcutaneous electric nerve stimulation
randomized controlled trial
Lead sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of participants with an average increasing of one or more complete spontaneous bowel movements from baseline at week 8.
timeFrame: Baseline，week 8
Secondary outcomes:
measure: The proportion of participants with an average increasing of one or more complete spontaneous bowel movements
timeFrame: Baseline，week 4，week 20 and week 32
measure: Change number in CSBMS
timeFrame: Baseline，week 4，week 8, week 20 and week 32
measure: Change number in SBMS
timeFrame: Baseline，week 4，week 8, week 20 and week 32
measure: The proportion of participants with type3 or type 4 stool character
timeFrame: Baseline，week 4，week 8, week 20 and week 32
measure: Change number of average score in defecation difficulty
timeFrame: Baseline，week 4，week 8, week 20 and week 32
measure: Change number of PAC-QOL score
timeFrame: Baseline，week 8
measure: The proportion and average amount of using cathartics
timeFrame: weeks -1 , 4 , 8 , 20 and 32.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study officials:
affiliation: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
name: Yuxiao Zeng
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Pfeifer J. Surgical options to treat constipation: A brief overview. Rozhl Chir. 2015 Sep;94(9):349-61.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.