NCT00945074

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
171

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

September 22, 2016

Status Verified

September 1, 2016

Enrollment Period

7.8 years

First QC Date

July 21, 2009

Last Update Submit

September 21, 2016

Conditions

Irritable Bowel Syndrome

Keywords

AcupunctureMoxibustionTraditional Chinese MedicineComplementary MedicineIrritable Bowel SyndromeIBS

Outcome Measures

Primary Outcomes (1)

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

    Six months

Secondary Outcomes (3)

  • Global improvement (CGIS)

    Six months

  • Quality of life (IBS-QOL & SF-36)

    Six months

  • Psychological distress (SCL-90)

    Six months

Study Arms (3)

Condition 1

EXPERIMENTAL

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

Other: Standard Acupuncture/Moxibustion (fixed protocol)

Condition 2: Individualized Acupuncture/Moxibustion

EXPERIMENTAL

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

Other: Individualized Acupuncture/Moxibustion

Condition 3: Control

SHAM COMPARATOR

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

Other: Sham/Placebo Acupuncture/Moxibustion

Interventions

Standard Acupuncture/Moxibustion (fixed protocol)OTHER

Acupuncture/Moxibustion

Condition 1
Individualized Acupuncture/MoxibustionOTHER

Individualized Tailored Acupuncture/Moxibustion Protocol based on TCM Diagnosis

Condition 2: Individualized Acupuncture/Moxibustion
Sham/Placebo Acupuncture/MoxibustionOTHER

Sham/Placebo Acupuncture/Moxibustion Protocol: Not-Active

Condition 3: Control

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University, Division of Special Studies in Symptom Management

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Moxibustion

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Acupuncture TherapyComplementary TherapiesTherapeutics

Study Officials

  • Joyce K Anastasi, PhD, DrNP, FAAN, LAc

    New York University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 21, 2009

First Posted

July 23, 2009

Study Start

July 1, 2009

Primary Completion

April 1, 2017

Study Completion

December 1, 2017

Last Updated

September 22, 2016

Record last verified: 2016-09

Locations

US(1)