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

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ClinicalTrials.gov Identifier: NCT01726504
Recruitment Status : Completed
First Posted : November 15, 2012
Results First Posted : November 23, 2015
Last Update Posted : February 22, 2016
Sponsor:
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

Tracking Information
First Submitted Date  ICMJE October 30, 2012
First Posted Date  ICMJE November 15, 2012
Results First Submitted Date  ICMJE September 3, 2015
Results First Posted Date  ICMJE November 23, 2015
Last Update Posted Date February 22, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 21, 2015)
the Change in Mean Weekly CSBMs During Weeks 1-8 Since Treatment [ Time Frame: Baseline and weeks 1-8 ]
the change number in mean weekly CSBMs during weeks 1-8 since treatment compared with baseline.
Original Primary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
Increased value of weekly average CSBM [ Time Frame: 1-8 weeks ]
The increased value of weekly average CSBM (complete spontaneous bowel movement) during 8 weeks treatment, compared with baseline.
Change History Complete list of historical versions of study NCT01726504 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 21, 2016)
  • the Percentage of Participants With Three or More Weekly CSBMs [ Time Frame: 1-20 weeks ]
    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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and 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 [ Time Frame: Baseline and weeks 1-8 ]
    The degree of straining during self-defecation: The severity of straining is graded using a 4-point ordinal scale. 0 = not at all
    1. = more straining than not
    2. = a great deal
    3. = 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) [ Time Frame: baseline and the end of 8th week ]
    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 [ Time Frame: 1-8 weeks ]
  • Mean of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used [ Time Frame: 1-20 weeks ]
    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 [ Time Frame: 1-20 weeks ]
  • Percentage of Weekly Frequency of Rescue Medicine and Other Defecation Assistances Used [ Time Frame: 1-20 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 14, 2012)
  • The proportion of participants having three or more CSBMs on average per week [ Time Frame: 1-20 weeks ]
    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 ]
    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 ]
    The increased value of weekly average SBMs (spontaneous bowel movement) during 8-week treatment, compared with baseline.
  • Stool consistency [ Time Frame: 1-8 weeks ]
    Stool consistency (Bristol Stool Scale)
  • degree of difficulty in defecation [ Time Frame: 1-8 weeks ]
    The degree of straining during defecation: The severity of straining is graded using a 4-point ordinal scale. 0 = not at all
    1. = more straining than not
    2. = a great deal
    3. = an extreme amount, need finger manipulation to defecate
  • PAC-QOL [ Time Frame: baseline and end of 8th weeks ]
    PAC-QOL(Patient-Assessment of Constipation Quality Of Life)
  • incidence of adverse events [ Time Frame: 1-8 weeks ]
  • Usage of medicine for constipation [ Time Frame: 1-20 weeks ]
    Any medicine for constipation used during the trial will be recorded, as well as the dosage and amount of every drug.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation
Official Title  ICMJE The Efficacy and Safety Study of Electro-acupuncture for Severe Chronic Functional Constipation - a Multi-center, Randomized Controlled Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Constipation
Intervention  ICMJE
  • Device: electro-acupuncture
    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.
    Other Name: SDZ-V electro-acupuncture apparatus (Huatuo, made in China)
  • Device: sham electro-acupuncture
    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.
    Other Name: Sham SDZ-V electro-acupuncture apparatus (Huatuo, China)
Study Arms  ICMJE
  • Experimental: electro-acupuncture
    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.

    Intervention: Device: electro-acupuncture
  • Sham Comparator: sham electro-acupuncture
    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.

    Intervention: Device: sham electro-acupuncture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 21, 2015)
1075
Original Estimated Enrollment  ICMJE
 (submitted: November 14, 2012)
1034
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01726504
Other Study ID Numbers  ICMJE 2012BAI24B01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Liu Baoyan, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Study Sponsor  ICMJE Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators  ICMJE Ministry of Science and Technology of the People´s Republic of China
Investigators  ICMJE
Principal Investigator: Baoyan Liu, Master Vice President of China Academy of Chinese Medical Sciences
PRS Account Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP