The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
This study is currently recruiting participants.
Verified November 2012 by Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Liu Baoyan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier:
NCT01726504
First received: October 30, 2012
Last updated: November 14, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation |
Device: electro-acupuncture Device: sham electro-acupuncture |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
Primary Outcome Measures:
- Increased value of weekly average CSBM [ Time Frame: 1-8 weeks ] [ Designated as safety issue: No ]The increased value of weekly average CSBM (complete spontaneous bowel movement) during 8 weeks treatment, compared with baseline.
Secondary Outcome Measures:
- The proportion of participants having three or more CSBMs on average per week [ Time Frame: 1-20 weeks ] [ Designated as safety issue: No ]The proportion of participants having three or more CSBMs on average per week during the 8-week treatment and 9-20th weeks.
- The increased value of weekly average CSBMs [ Time Frame: 9-20 weeks ] [ Designated as safety issue: No ]The increased value of weekly average CSBMs during 9-20th weeks, compared with baseline.
- The increased value of weekly average SBMs [ Time Frame: 1-8 weeks ] [ Designated as safety issue: No ]The increased value of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.
- Stool consistency [ Time Frame: 1-8 weeks ] [ Designated as safety issue: No ]Stool consistency (Bristol Stool Scale)
- degree of difficulty in defecation [ Time Frame: 1-8 weeks ] [ Designated as safety issue: No ]
The degree of straining during defecation: The severity of straining is graded using a 4-point ordinal scale.
0 = not at all
- = more straining than not
- = a great deal
- = an extreme amount, need finger manipulation to defecate
- PAC-QOL [ Time Frame: baseline and end of 8th weeks ] [ Designated as safety issue: No ]PAC-QOL（Patient-Assessment of Constipation Quality Of Life）
- incidence of adverse events [ Time Frame: 1-8 weeks ] [ Designated as safety issue: Yes ]
- Usage of medicine for constipation [ Time Frame: 1-20 weeks ] [ Designated as safety issue: No ]Any medicine for constipation used during the trial will be recorded, as well as the dosage and amount of every drug.
| Estimated Enrollment: | 1034 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Experimental: electro-acupuncture
Every session lasts for 30 min per 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
Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 2 or 3 cun into bilateral ST25 and SP14 vertically until touching the parietal peritoneum.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 15 Hz and electric current 0.1-1.0 mA.The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are given 1 cun depth acupuncture 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.
Other Name: SDZ-V electro-acupuncture apparatus (Huatuo, made in China)
|
Sham Comparator: sham electro-acupuncture
Length of Treatment and the treatment sessions are the same as treatment group. |
Device: sham electro-acupuncture
Procedure: sham electro-acupuncture; Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37). Sham points location:1 cun away from ST25,middle of Spleen and Stomach Channel;1 cun from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance: The needle is inserted by 0.3-0.5 cun (the needle can be vertically fixed on the skin). No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,15 Hz and electric current 0.5 mA. 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.
Other Name: Sham SDZ-V electro-acupuncture apparatus (Huatuo, China)
|
Detailed Description:
Chronic functional constipation is a common disease. To date there has not specific therapy on chronic functional constipation. Systematic reviews indicate that acupuncture is probably effective for the disease, but the evidence is limited. Recently, we have finished a multi-center clinical trial of individualized deep electro-acupuncture (EA) for chronic functional constipation (n=460, Registration ID: NCT00508482) which preliminarily showed EA was effective.
This multi-center large-sample randomized controlled clinical trial of acupuncture for severe functional constipation is designed to confirm the efficacy and safety of EA.
This project is conducted by Chinese experts, supported by the Chinese Government. The research result is expected to provide high quality evidence of EA for chronic functional constipation.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Meet 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.
- 18-75 years old
- No use of medicine for constipation during the two weeks before enrollment (except rescue medication); None acupuncture treatment for constipation in recent 3 months; never join any other trial in process in 3 months
- Volunteered to join this research and signed the informed consent
Exclusion Criteria:
- Irritable bowel syndrome (IBS) and constipation secondary to endocrine, metabolic, nervous or postoperative diseases or drugs.
- With serious cardiovascular, liver, kidney, or psychiatric disease, cognitive dysfunction or aphasia, or severe dystrophy that cannot cooperate to be examined or treated
- During pregnancy or lactation period
- With abdominal aneurysm, hepatosplenomegaly, etc.
- Blood coagulation disorders, or administration of anticoagulant agents, such as warfarin and heparin, etc.
- With cardiac pacemaker
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726504
Contacts
| Contact: Zhishun Liu, M.D. | 0086-13651016313 | liuzhishun@yahoo.com.cn |
| Contact: Jia Liu, M.D. | 0086-18810877011 | marie_liujia@yahoo.com.cn |
Locations
| China, Beijing | |
| Guang'anmen Hospital of China Academy of Chinese Medical Sciences | Recruiting |
| Beijing, Beijing, China, 100700 | |
| Contact: Baoyan Liu, M.D. 0086-18810877011 baoyan.liu.cacms@gmail.com | |
| Principal Investigator: Baoyan Liu, Master | |
Sponsors and Collaborators
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Ministry of Science and Technology of the People´s Republic of China
Investigators
| Principal Investigator: | Baoyan Liu, Master | Vice President of China Academy of Chinese Medical Sciences |
More Information
No publications provided
| Responsible Party: | Liu Baoyan, Vice President of China Academy of Chinese Medical Sciences, Guang'anmen Hospital of China Academy of Chinese Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01726504 History of Changes |
| Other Study ID Numbers: | 2012BAI24B01 |
| Study First Received: | October 30, 2012 |
| Last Updated: | November 14, 2012 |
| Health Authority: | China: State Administration of Traditional Chinese Medicine of the People's Republic of China |
Keywords provided by Guang'anmen Hospital of China Academy of Chinese Medical Sciences:
|
chronic functional constipation electro-acupuncture multi-center randomized controlled trial efficacy |
Additional relevant MeSH terms:
|
Constipation Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on June 18, 2013