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Acupuncture/Moxibustion for Irritable Bowel Syndrome (IBS) (Acu/MoxaIBS)

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard Acupuncture/Moxibustion (fixed protocol)
Individualized Acupuncture/Moxibustion
Sham/Placebo Acupuncture/Moxibustion
Sponsored by
New York University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Acupuncture, Moxibustion, Traditional Chinese Medicine, Complementary Medicine, Irritable Bowel Syndrome, IBS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women 18 to 70 years of age who have a prior diagnosis of IBS (6 months or greater)
  • Verification/documentation of subject's diagnosis of IBS (ROME III criteria).
  • Subjects must be experiencing recurrent abdominal pain/discomfort with two or more of the following, as described in the Rome III criteria: (1) Improvement with defecation; and/or (2) Onset associated with a change in frequency of stool; and/or (3) Onset associated with a change in form (appearance) of stool.
  • Four-week prospective daily symptom diary must show: IBS with diarrhea IBS-D), defined by ROME III
  • Subjects agree to complete symptom diaries and return completed diaries at all sessions.
  • Women of childbearing age must agree to use an acceptable method of contraception.
  • Subjects may be on antidepressants(on stable regimen for at least 6 months)

Exclusion Criteria:

  • Individuals who have IBS-Mixed, IBS-Unspecified or IBS-Constipation
  • Individuals who have a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (eg., colon cancer, colitis, Crohn's, celiac, endometriosis, prostate cancer) or lactose intolerance
  • Individuals experiencing alarm symptoms according to Rome III
  • Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry.
  • Individuals who are currently taking the following medications more than 3 days a week: antibiotics, narcotics, cholestyramine, colchicine, iron supplements, antispasmotics, benzodiazepines
  • Individuals currently receiving other types of complementary therapies such as herbs, massage, reiki etc.;Individuals receiving behavioral therapies for IBS; Individuals receiving physical therapy for pelvic pain
  • Pregnant women.
  • Individuals with an acute medical condition, i.e., pneumonia and/or conditions that requiring acute medical attention.
  • Individuals with asthma or smoke allergy
  • Individuals receiving acupuncture currently and less than 6 months prior to enrollment and/or history of receiving moxibustion
  • Individuals with plans for travel, lifestyle change, or other activity that would preclude attending the planned study sessions or recording daily dietary information.

Sites / Locations

  • New York University, Division of Special Studies in Symptom Management

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Condition 1

Condition 2: Individualized Acupuncture/Moxibustion

Condition 3: Control

Arm Description

Condition 1: Subjects receive Standard Acu/Moxa (fixed protocol)

Condition 2: Subjects receive Individualized Acupuncture/Moxibustion (patient-oriented, based on traditional Chinese medicine diagnosis).

Condition 3: Subjects receive Sham Acupuncture/Placebo Moxibustion (control group)

Outcomes

Primary Outcome Measures

Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency

Secondary Outcome Measures

Global improvement (CGIS)
Quality of life (IBS-QOL & SF-36)
Psychological distress (SCL-90)

Full Information

First Posted
July 21, 2009
Last Updated
September 21, 2016
Sponsor
New York University
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00945074
Brief Title
Acupuncture/Moxibustion for Irritable Bowel Syndrome (IBS)
Acronym
Acu/MoxaIBS
Official Title
Protocol- vs. Patient-Oriented TCM Practices: A RCT for IBS Symptom Management
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York University
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study is to test the efficacy of a symptom management treatment strategy, namely, Acupuncture/Moxibustion (Acu/Moxa) to improve the symptoms associated with Irritable Bowel Syndrome (IBS) in persons between the ages of 18 to 70 years. IBS has been defined as abdominal pain or discomfort in the mid or lower gastrointestinal (GI) tract, associated with defecation or a change in bowel patterns and with features of disordered defecation. Current therapies include dietary modification, psychotherapy and pharmacological therapies. Traditional eastern approaches offer a therapeutic approach to symptom management that is subtle, holistic and holds promise as an intervention for IBS. This study will enroll 171 men and women experiencing IBS with diarrhea (IBS-D) defined by the ROME III criteria. Subjects will be randomized (by chance) to one of three experimental intervention conditions: Condition 1,subjects receive Standard Acu/Moxa; Condition 2, subjects receive Individualized Acu/Moxa and Condition 3, subjects receive Sham Acupuncture/Placebo Moxibustion(control group). Subjects will attend a screening/intake session followed by two treatment sessions per week for 4 weeks, one treatment session per week for 4 weeks, and 2 non-treatment follow-up sessions at weeks 12 and 24. All subjects will be assessed by a diagnostic acupuncturist (blinded to treatment assignments), receive interventions appropriate to their condition assignment by treating acupuncturists, be administered the same instruments, and submit their symptom diaries for data entry and analysis. All subjects will complete a prospective symptom diary for the duration of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Acupuncture, Moxibustion, Traditional Chinese Medicine, Complementary Medicine, Irritable Bowel Syndrome, IBS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Condition 1
Arm Type
Experimental
Arm Description
Condition 1: Subjects receive Standard Acu/Moxa (fixed protocol)
Arm Title
Condition 2: Individualized Acupuncture/Moxibustion
Arm Type
Experimental
Arm Description
Condition 2: Subjects receive Individualized Acupuncture/Moxibustion (patient-oriented, based on traditional Chinese medicine diagnosis).
Arm Title
Condition 3: Control
Arm Type
Sham Comparator
Arm Description
Condition 3: Subjects receive Sham Acupuncture/Placebo Moxibustion (control group)
Intervention Type
Other
Intervention Name(s)
Standard Acupuncture/Moxibustion (fixed protocol)
Intervention Description
Acupuncture/Moxibustion
Intervention Type
Other
Intervention Name(s)
Individualized Acupuncture/Moxibustion
Intervention Description
Individualized Tailored Acupuncture/Moxibustion Protocol based on TCM Diagnosis
Intervention Type
Other
Intervention Name(s)
Sham/Placebo Acupuncture/Moxibustion
Intervention Description
Sham/Placebo Acupuncture/Moxibustion Protocol: Not-Active
Primary Outcome Measure Information:
Title
Patient-rated abdominal pain/discomfort and IBS-Secondary symptom rating: intestinal gas, bloating and stool consistency
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Global improvement (CGIS)
Time Frame
Six months
Title
Quality of life (IBS-QOL & SF-36)
Time Frame
Six months
Title
Psychological distress (SCL-90)
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women 18 to 70 years of age who have a prior diagnosis of IBS (6 months or greater) Verification/documentation of subject's diagnosis of IBS (ROME III criteria). Subjects must be experiencing recurrent abdominal pain/discomfort with two or more of the following, as described in the Rome III criteria: (1) Improvement with defecation; and/or (2) Onset associated with a change in frequency of stool; and/or (3) Onset associated with a change in form (appearance) of stool. Four-week prospective daily symptom diary must show: IBS with diarrhea IBS-D), defined by ROME III Subjects agree to complete symptom diaries and return completed diaries at all sessions. Women of childbearing age must agree to use an acceptable method of contraception. Subjects may be on antidepressants(on stable regimen for at least 6 months) Exclusion Criteria: Individuals who have IBS-Mixed, IBS-Unspecified or IBS-Constipation Individuals who have a history of co-existing gastrointestinal, and/or gynecological, and/or urologic pathology (eg., colon cancer, colitis, Crohn's, celiac, endometriosis, prostate cancer) or lactose intolerance Individuals experiencing alarm symptoms according to Rome III Abdominal surgery, with the exception of uncomplicated removal of the appendix, uterus, or gallbladder more than 6 months prior to study entry. Individuals who are currently taking the following medications more than 3 days a week: antibiotics, narcotics, cholestyramine, colchicine, iron supplements, antispasmotics, benzodiazepines Individuals currently receiving other types of complementary therapies such as herbs, massage, reiki etc.;Individuals receiving behavioral therapies for IBS; Individuals receiving physical therapy for pelvic pain Pregnant women. Individuals with an acute medical condition, i.e., pneumonia and/or conditions that requiring acute medical attention. Individuals with asthma or smoke allergy Individuals receiving acupuncture currently and less than 6 months prior to enrollment and/or history of receiving moxibustion Individuals with plans for travel, lifestyle change, or other activity that would preclude attending the planned study sessions or recording daily dietary information.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce K Anastasi, PhD, DrNP, FAAN, LAc
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University, Division of Special Studies in Symptom Management
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States

12. IPD Sharing Statement

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Acupuncture/Moxibustion for Irritable Bowel Syndrome (IBS)

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