The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial

Conditions
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Constipation

Intervention / Treatment
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* Device: electro-acupuncture
* Device: sham electro-acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; 18-75 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electro-acupuncture<br>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). 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<br>* 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.<br>* Other names: SDZ-V electro-acupuncture apparatus (Huatuo, made in China);|
| Sham Comparator: sham electro-acupuncture<br>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). 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<br>* 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.<br>* Other names: Sham SDZ-V electro-acupuncture apparatus (Huatuo, China);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Percentage of Participants With Three or More Weekly CSBMs | the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20 | 1-20 weeks | 
| Changes in Mean Weekly CSBMs During Weeks 9-20 | The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline. | Baseline and weeks 9-20 | 
| Mean Weekly SBMs During Weeks 1-8 | The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline. | Baseline and weeks 1-8 | 
| Mean Scores for Stool Consistency and Straining During Weeks 1-8 | average weekly stool consistency (Bristol Stool Scale) assessment of self-defecation during the 1-8weeks of treatment,compared with baseline. Bristol Stool Scale including 7-type, scored by 1 to 7 respectively.Type 1: Separate hard lumps, like nuts (hard to pass); Type 2: Sausage-shaped, but lumpy; Type 3: Like a sausage but with cracks on its surface; Type 4: Like a sausage or snake, smooth and soft; Type 5: Soft blobs with clear cut edges (passed easily); Type 6: Fluffy pieces with ragged edges, a mushy stool; Type 7: Watery, no solid pieces. Entirely liquid. Type 3, 4 are normal. | Baseline and weeks 1-8 | 
| Change of Average Weekly Degree of Difficulty in Defecation From Baseline | 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 | Baseline and weeks 1-8 | 
| Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL) | Patient-Assessment of Constipation Quality Of Life(PAC-QOL) ranges are 28-140,and higher values represent a worse outcome.Subscales are summed to compute the total score. The changed score of PAC-QOL at week 8, compared with baseline. | baseline and the end of 8th week | 
| Number of Participants With Adverse Events Related to Acupuncture |  | 1-8 weeks | 
| Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements. | 1-20 weeks | 
| The Number of Participants Using Rescue Medicine for Constipation |  | 1-20 weeks | 
| Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used | Rescue medicine for constipation during the trial will be recorded. For rescue medicine, any participants experiencing no bowel movements for 3 or more consecutive days during the whole trial period were allowed to use a 110 ml glycerol anal enema or 40-60 ml sorbitol anal enema as a rescue medicine with documentation in the stool diary.Other If a patient used other medicine, it should be also recorded in the diary.Only the frequences of rescue medicine and other medicine for constipation will be recorded in diary by patient. Weekly frequencies were combined across Weeks 1-8 and 9-20 per participant by averaged across all measurements. | 1-20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic functional constipation, electro-acupuncture, multi-center randomized controlled trial, efficacy, safety