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Effect of Electroacupuncture in Patients With Irritable Bowel Syndrome

NCT00900965 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2009-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Irritable Bowel Syndrome

Interventions

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.

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.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Winnie C.W. Chu, MBChB, FRCR, MD, FHKAM · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • China

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00900965 on ClinicalTrials.gov