NCT01726504

Brief Summary

The main purpose of this study is to evaluate efficacy of electro-acupuncture for severe functional constipation compared with sham acupuncture, used as placebo; the secondary purpose is to evaluate the safety and post-treatment effect of electro-acupuncture.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,075

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

November 15, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
12 months until next milestone

Results Posted

Study results publicly available

November 23, 2015

Completed
Last Updated

February 22, 2016

Status Verified

January 1, 2016

Enrollment Period

2 years

First QC Date

October 30, 2012

Results QC Date

September 3, 2015

Last Update Submit

January 21, 2016

Conditions

Constipation

Keywords

chronic functional constipationelectro-acupuncturemulti-center randomized controlled trialefficacysafety

Outcome Measures

Primary Outcomes (1)

  • the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment

    the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.

    Baseline and weeks 1-8

Secondary Outcomes (10)

  • the Percentage of Participants With Three or More Weekly CSBMs

    1-20 weeks

  • Changes in Mean Weekly CSBMs During Weeks 9-20

    Baseline and weeks 9-20

  • Mean Weekly SBMs During Weeks 1-8

    Baseline and weeks 1-8

  • Mean Scores for Stool Consistency and Straining During Weeks 1-8

    Baseline and weeks 1-8

  • Change of Average Weekly Degree of Difficulty in Defecation From Baseline

    Baseline and weeks 1-8

  • +5 more secondary outcomes

Study Arms (2)

electro-acupuncture

EXPERIMENTAL

1. The electric stimulator is applied to bilateral ST25andSP14 with dilatational wave10/50 Hz and electric current0.1-1.0mA.They are given acupuncture with 0.3×50mm or 0.35×75mm needles by inserting30-70mm and twirling lifting andthrusting 3 times.Dosage:The needle arrives the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). 2. Bilateral ST37 are given conventional acupuncture with 0.30mm×40mm needles by inserting 25-30mm and twirling lifting and thrusting for 3.Dosage:Local sour and heavy feeling is the appropriate dose. Every session lasts for 30min/day.The participants are treated continuously for 8 weeks.During 8-week treatment the first 2 weeks,5 sessions per week,and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.

Device: electro-acupuncture

sham electro-acupuncture

SHAM COMPARATOR

1. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave, 10/50 Hz and electric current 0.5mA. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. The needle is inserted by 3mm-5mm (the needle can be vertically fixed on the skin). 2. Bilateral ST37 are given acupuncture with 3mm-5mm (the needle can be vertically fixed on the skin). Length of Treatment and the treatment sessions are the same as treatment group.

Device: sham electro-acupuncture

Interventions

electro-acupunctureDEVICE

Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 30to70mm into bilateral ST25 and SP14 vertically until piercing the abdominal muscle layer.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 10/50 Hz and electric current 0.1-1.0mA. The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are inserted 25-30mm and then twirling lifting and thrusting for 3 times.Local sour and heavy feeling is appropriate dose. Steady small twirling lifting and thrusting 3 times in all. 30 min/per day/per session.During the 8 weeks treatment, the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.

Also known as: SDZ-V electro-acupuncture apparatus (Huatuo, made in China)
electro-acupuncture
sham electro-acupunctureDEVICE

Procedure:sham electro-acupuncture;Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37).Sham points location:20mm away from ST25,middle of Spleen and Stomach Channel;30mm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance:The needle is inserted with needle of 0.30×25mm by 3-5mm. No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,10/50 Hz and electric current 0.5mA.The mental wire has been cut off with a same outlook as the treatment group.The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.

Also known as: Sham SDZ-V electro-acupuncture apparatus (Huatuo, China)
sham electro-acupuncture

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • meeting the diagnosis of Rome III criteria for chronic functional constipation;
  • severe chronic constipation: two or fewer spontaneous complete bowel movements per week for more than 3 months;
  • years old;
  • no use of medicine for constipation during the two weeks before enrollment (except rescue medication);
  • no acupuncture treatment for constipation in recent 3 months;
  • never joined any other trial in process in 3 months;
  • volunteered to join this research and signed the informed consent.

You may not qualify if:

  • Irritable bowel syndrome (IBS) and constipation caused by endocrine, metabolic, nervous or postoperative diseases or drugs;
  • constipation accompanied by serious cardiovascular, hepatic, renal, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy affecting the cooperation for examination or treatment;
  • pregnant women or women in lactation period
  • constipation accompanied by abdominal aneurysm, hepatosplenomegaly, etcetera;
  • bleeding disorders, or regular anticoagulant drug users, such as warfarin and heparin, etcetera;
  • cardiac pacemaker carrier.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100700, China

Location

Related Publications (3)

  • Wang Y, Liu Y, Zhou K, Bauer BA, Liu B, Su T, Mo Q, Liu Z. The duration of acupuncture effects and its associated factors in chronic severe functional constipation: secondary analysis of a randomized controlled trial. Therap Adv Gastroenterol. 2019 Oct 9;12:1756284819881859. doi: 10.1177/1756284819881859. eCollection 2019.

    PMID: 31636713DERIVED

  • 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: 27618593DERIVED

  • Liu Z, Liu J, Zhao Y, Cai Y, He L, Xu H, Zhou X, Yan S, Lao L, Liu B. The efficacy and safety study of electro-acupuncture for severe chronic functional constipation: study protocol for a multicenter, randomized, controlled trial. Trials. 2013 Jun 15;14:176. doi: 10.1186/1745-6215-14-176.

    PMID: 23768191DERIVED

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

The 8-week treatment and 12-week follow-up may not be long enough for EA to show its specific therapeutic effect. Efficacy of electro-acupuncture in relieving severe constipation was evaluated without classifying the types of constipation.

Results Point of Contact

Title
Liu Zhishun
Organization
Guang An Men Hosptial of China Academy of Chinese Medical Sciences
liuzhishun@hotmail.com
86 13651016313

Study Officials

  • Baoyan Liu, Master

    Vice President of China Academy of Chinese Medical Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice President of China Academy of Chinese Medical Sciences

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 15, 2012

Study Start

October 1, 2012

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

February 22, 2016

Results First Posted

November 23, 2015

Record last verified: 2016-01

Locations

CN(1)