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

NCT03391635 | Completed

• 1 other identifier: GAMHospital20171222
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Functional Constipation

Keywords

acupuncture; functional constipation; transcutaneous electric nerve stimulation; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The proportion of participants with an average increasing of one or more complete spontaneous bowel movements

  Baseline，week 4，week 20 and week 32

• Change number in CSBMS

  Baseline，week 4，week 8, week 20 and week 32

• Change number in SBMS

  Baseline，week 4，week 8, week 20 and week 32

• The proportion of participants with type3 or type 4 stool character

  Baseline，week 4，week 8, week 20 and week 32

• Change number of average score in defecation difficulty

  Baseline，week 4，week 8, week 20 and week 32

Study Arms (2)

Electroacupuncture

EXPERIMENTAL

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

TranscutaneousElectricNerveStimulation

ACTIVE COMPARATOR

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

Interventions

Electroacupuncture DEVICE

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

Electroacupuncture

TranscutaneousElectricNerveStimulation DEVICE

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

TranscutaneousElectricNerveStimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, 100053, China

Location

Related Publications (16)

• 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.

  PMID: 21382575 RESULT

• 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.

  PMID: 16000928 RESULT

• 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.

  PMID: 22786523 RESULT

• 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.

  PMID: 17464377 RESULT

• 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.

  PMID: 21205879 RESULT

• 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.

  PMID: 17497967 RESULT

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

  PMID: 26537099 RESULT

• 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.

  PMID: 21724490 RESULT

• 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.

  PMID: 22295840 RESULT

• 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.

  PMID: 27618593 RESULT

• 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.

  PMID: 16678553 RESULT

• 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.

  PMID: 9299672 RESULT

• 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.

  PMID: 16036506 RESULT

• 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.

  PMID: 29166673 RESULT

• 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.

  PMID: 20006033 RESULT

• 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.

  PMID: 19524752 RESULT

MeSH Terms

Interventions

Electroacupuncture; Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Yuxiao Zeng

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate student of China Academy of Chinese Medical Sciences

Study Record Dates

• First Submitted: December 22, 2017
• First Posted: January 5, 2018
• Study Start: July 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2020
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)