Effect of Electroacupuncture in Patients With Irritable Bowel Syndrome (IBS_FBM)

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00900965
First received: May 12, 2009
Last updated: June 30, 2009
Last verified: June 2009
  Purpose

Irritable bowel syndrome (IBS) is the most common digestive disorder that affects more than 5% of population in Hong Kong. However, there is no effective treatment of IBS using Western Medicine. Acupuncture, a traditional therapeutic modality, has been used in China for thousands of years for various pain disorders. In addition to analgesia, acupuncture has also been shown to influence physiology of gastrointestinal tract. The investigators set out to evaluate the therapeutic value of acupuncture in IBS. The investigators will study its effects on rectal sensation and brain activity in patients with IBS.

All patients will be evaluated for study eligibility at visit 1 (baseline). Baseline assessment includes individual IBS symptoms (pain/discomfort, bloating, constipation, and diarrhea) as perceived by patients will be scored. The syndrome of IBS patients will also be recorded and analyzed based on the Chinese medicine theories. All patients will then undergo baseline rectal barostat for thresholds of rectal sensation. At visit 2, eligible patients will be randomly assigned to either (1) electroacupuncture or (2) sham electroacupuncture treatment groups. Functional Magnetic Resonance Imaging (fMRI) scanning will be performed before, during and after the electroacupuncture or sham electroacupuncture treatment.


Condition Intervention
Irritable Bowel Syndrome
Device: Electroacupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair))
Device: Sham acupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair))

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Study on the Effect of Electroacupuncture on Functional Brain Mapping in Patients With Irritable Bowel Syndrome

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Sensory and pain thresholds as determined by rectal barostat [ Time Frame: At baseline study visit ] [ Designated as safety issue: No ]
  • Degree of cortical activation as determined by functional MRI [ Time Frame: At study visit 2 ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: April 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Electroacupuncture treatment
A specially designed copper needle (0.22 x 4 mm), which can be used safely in MRI suite, will be inserted through a plaster over the respective acupoints, under which a plastic ring will be positioned, connected with electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair) through wires with stimulation frequency of 150 Hz, lasting for 30 minutes.
Device: Electroacupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair))
A specially designed copper needle (0.22 x 4 mm), which can be used safely in MRI suite, will be inserted through a plaster over the respective acupoints, under which a plastic ring will be positioned, connected with electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair) through wires with stimulation frequency of 150 Hz, lasting for 30 minutes.
Other Name: electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair)
Sham Comparator: Sham acupunture treatment
Needle will be positioned at 2 cm away from the true respective acupoints, with a blunted, telescopic placebo needle. The same electric stimulation will be the same as real acupuncture treatment.
Device: Sham acupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair))
Needle will be positioned at 2 cm away from the true respective acupoints, with a blunted, telescopic placebo needle. The same electric stimulation will be the same as real acupuncture treatment.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Irritable bowel syndrome of diarrhea type as defined by Rome III criteria
  • Age 18-65 years
  • Normal colonic evaluation within 12 months (with either colonoscopy or barium study)

Exclusion Criteria:

  • IBS-constipation, mixed or unsubtyped
  • Pregnancy
  • Medical history of organic colonic bowel disease
  • History of sensitivity to acupuncture
  • Psychiatric or additive disorder
  • Patients who have received acupuncture in the past 6 months
  • Concomitant medications including anti-diarrhea agent, anti-depressant, narcotic analgesic and anti-cholinergic
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900965

Locations
China
The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Winnie C.W. Chu, MBChB, FRCR, MD, FHKAM Chinese University of Hong Kong
  More Information

No publications provided

Responsible Party: Prof Winnie C.W. Chu, The Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00900965     History of Changes
Other Study ID Numbers: IBS_FBM
Study First Received: May 12, 2009
Last Updated: June 30, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Chinese University of Hong Kong:
irritable bowel syndrome
IBS
fMRI
acupuncture
functional
brain

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 22, 2014