Irritable Bowel Syndrome |
Irritable Bowel Syndrome (IBS); Spastic Colon |
Clinical Trial: Acupuncture for Irritable Bowel Syndrome
This study is currently recruiting patients.
|
Purpose
Little is known about acupuncture's efficacy for Irritable Bowel Syndrome (IBS). This trial uses a manualized acupuncture treatment format that closely follows clinical practice and allows flexibility in designing individualized treatments. In addition, a second parallel qualitative study will follow a subgroup of patients throughout the trial to explore the relationships between patients' interpretations and understandings (what anthropologists call "meaning") of irritable bowel and their response to treatment. Cortisol levels (an important stress hormone) will also be assessed.
This will be a 3-arm trial: Active acupuncture, placebo acupuncture, and wait list.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Irritable Bowel Syndrome | Device: Acupuncture | Phase I Phase II |
MedlinePlus related topics: Irritable Bowel Syndrome
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Expected Total Enrollment: 260
Study start: February 2004; Expected completion: September 2005
Eligibility
Ages Eligible for Study: 18 Years - 80 Years, Genders Eligible for Study: Both
Criteria
Inclusion criteria:
Diagnosis of Irritable Bowel Syndrome based on Rome II criteria, including at least 12 weeks of abdominal discomfort or pain in the last 12 months with at least 2 of the following features:
- Relief with defecation
- Onset associated with a change in stool frequency
- Onset associated with a change in form/appearance of stool
Exclusion criteria:
- History of severe or intractable IBS, defined as continuous, unremitting and several abdominal pain greater than 12 hours/day
- Previous acupuncture treatment
- Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study
- History of laxative abuse
- Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable)
- History of metabolic or inflammatory disease that may affect bowel motility, eg.g., inflammatory bowel disease, diabetes mellitus, sarcoidosis
- Other significant illness as determined by Investigator
- History of drug or alcohol abuse w/in 2 years;
- Insufficient knowledge of English to complete self-assessments to participate in study
Location and Contact Information
Lisa Conboy, PhD 617-384-8565 lisa_conboy@hms.harvard.edu
Massachusetts
Harvard Medical School, Boston, Massachusetts, 02115, United States; Recruiting
Ted J. Kaptchuk, OMD, Principal Investigator
More Information
Record last reviewed: April 2005
Last Updated: April 7, 2005
Record first received: July 22, 2003
ClinicalTrials.gov Identifier: NCT00065403
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005

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