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

Functional Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03391635
• Other study ID #: GAMHospital20171222
• Status: Completed
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2022
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constipation
• Functional Constipation

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

References & Publications (16)

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: 10.10 — View Citation

Drossman DA. The functional gastrointestinal disorders and the Rome III process. Gastroenterology. 2006 Apr;130(5):1377-90. Review. — View 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. Review. Chinese. — View 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. Review. — View 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. Review. Update in: Cochrane Database Syst R — View 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 — View 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. — View 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 I — View 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. — View 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. Review. — View Citation

Paré 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 — View Citation

Pfeifer J. Surgical options to treat constipation: A brief overview. Rozhl Chir. 2015 Sep;94(9):349-61. Review. — View Citation

Remes Troche JM, Gómez Escudero O, Icaza Chávez ME, Noble Lugo A, López Colombo A, Bielsa MV, Charúa Guindic L; Asociación Mexicana de Gastroenterología. [Guidelines for diagnosis and treatment of constipation in Mexico. C) Medical and surgical treatment] — View 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. — View Citation

Wong SW, Lubowski DZ. Slow-transit constipation: evaluation and treatment. ANZ J Surg. 2007 May;77(5):320-8. Review. — View 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: 10.13 — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.