The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
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.
Device: sham electro-acupuncture
|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|
- Change of weekly average CSBM from baseline [ Time Frame: 1-8 weeks ] [ Designated as safety issue: No ]The changed number of weekly average CSBM (complete spontaneous bowel movement) during 8 weeks treatment, compared with baseline.
- 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.
- Change of weekly average CSBMs from baseline [ Time Frame: 9-20 weeks ] [ Designated as safety issue: No ]The changed number of weekly average CSBMs during 9-20th weeks, compared with baseline.
- Change of weekly average SBMs from baseline [ Time Frame: 1-8 weeks ] [ Designated as safety issue: No ]The changed number of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.
- Change of average weekly stool consistency assessment from baseline [ Time Frame: 1-8 weeks ] [ Designated as safety issue: No ]average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline
- Change of average weekly degree of difficulty in defecation from baseline [ Time Frame: 1-8 weeks ] [ Designated as safety issue: No ]
The degree of straining during self-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 average weekly degree of difficulty in self-defecation during 1-8weeks,compared with baseline
- 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.
|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)|
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.
Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 3 to 8 cm 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 inserted 3 cm 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:2cm away from ST25,middle of Spleen and Stomach Channel;3cm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance: The needle is inserted by 1 to 1.5cm (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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01726504
|Contact: Zhishun Liu, M.D.||email@example.com|
|Contact: Jia Liu, M.D.||firstname.lastname@example.org|
|Guang'anmen Hospital of China Academy of Chinese Medical Sciences||Recruiting|
|Beijing, Beijing, China, 100700|
|Contact: Baoyan Liu, M.D. 0086-18810877011 email@example.com|
|Principal Investigator: Baoyan Liu, Master|
|Principal Investigator:||Baoyan Liu, Master||Vice President of China Academy of Chinese Medical Sciences|