Back to resultsThe Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
Primary Purpose
Constipation
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
electro-acupuncture
sham electro-acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring chronic functional constipation, electro-acupuncture, multi-center randomized controlled trial, efficacy, safety
Eligibility Criteria
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.
Sites / Locations
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
electro-acupuncture
sham electro-acupuncture
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Changes in Mean Weekly CSBMs During Weeks 9-20
The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.
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.
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.
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
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.
Number of Participants With Adverse Events Related to Acupuncture
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.
The Number of Participants Using Rescue Medicine for Constipation
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.
Full Information
NCT ID
NCT01726504
First Posted
October 30, 2012
Last Updated
January 21, 2016
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People´s Republic of China
1. Study Identification
Unique Protocol Identification Number
NCT01726504
Brief Title
The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
Official Title
The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators
Ministry of Science and Technology of the People´s Republic of China
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
chronic functional constipation, electro-acupuncture, multi-center randomized controlled trial, efficacy, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1075 (Actual)
8. Arms, Groups, and Interventions
Arm Title
electro-acupuncture
Arm Type
Experimental
Arm Description
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.
Arm Title
sham electro-acupuncture
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
electro-acupuncture
Other Intervention Name(s)
SDZ-V electro-acupuncture apparatus (Huatuo, made in China)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham electro-acupuncture
Other Intervention Name(s)
Sham SDZ-V electro-acupuncture apparatus (Huatuo, China)
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment
Description
the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.
Time Frame
Baseline and weeks 1-8
Secondary Outcome Measure Information:
Title
the Percentage of Participants With Three or More Weekly CSBMs
Description
the percentage of participants with three or more weekly CSBMs during weeks 1-8 and weeks 9-20
Time Frame
1-20 weeks
Title
Changes in Mean Weekly CSBMs During Weeks 9-20
Description
The changed number in mean weekly average CSBMs during 9-20th weeks, compared with baseline.
Time Frame
Baseline and weeks 9-20
Title
Mean Weekly SBMs During Weeks 1-8
Description
The changed number in mean of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.
Time Frame
Baseline and weeks 1-8
Title
Mean Scores for Stool Consistency and Straining During Weeks 1-8
Description
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.
Time Frame
Baseline and weeks 1-8
Title
Change of Average Weekly Degree of Difficulty in Defecation From Baseline
Description
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
Time Frame
Baseline and weeks 1-8
Title
Then Change Score of Health-related Quality of Life Via Patient-Assessment of Constipation Quality Of Life (PAC-QOL)
Description
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.
Time Frame
baseline and the end of 8th week
Title
Number of Participants With Adverse Events Related to Acupuncture
Time Frame
1-8 weeks
Title
Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
Description
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.
Time Frame
1-20 weeks
Title
The Number of Participants Using Rescue Medicine for Constipation
Time Frame
1-20 weeks
Title
Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used
Description
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.
Time Frame
1-20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baoyan Liu, Master
Organizational Affiliation
Vice President of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100700
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
31636713
Citation
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.
Results Reference
derived
PubMed Identifier
27618593
Citation
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.
Results Reference
derived
PubMed Identifier
23768191
Citation
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.
Results Reference
derived
Learn more about this trial
The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
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