Effect of Electroacupuncture in Patients With Irritable Bowel Syndrome (IBS_FBM)
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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 |
- 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 |
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| China | |
| The Chinese University of Hong Kong, Prince of Wales Hospital | |
| Shatin, Hong Kong, China | |
| 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 May 22, 2013