Effect of Electroacupuncture in Patients With Irritable Bowel Syndrome

NCT00900965 | Completed DMC

• 1 other identifier: IBS_FBM
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

irritable bowel syndrome; IBS; fMRI; acupuncture; functional; brain

Outcome Measures

Primary Outcomes (2)

• Sensory and pain thresholds as determined by rectal barostat

  At baseline study visit

• Degree of cortical activation as determined by functional MRI

  At study visit 2

Study Arms (2)

Electroacupuncture treatment

ACTIVE COMPARATOR

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))

Sham acupunture treatment

SHAM COMPARATOR

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))

Interventions

Electroacupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair)) DEVICE

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.

Also known as: electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair)

Electroacupuncture treatment

Sham acupuncture treatment (electrical stimulation machine (EY-3308 Model, G6805-2 Mayfair)) DEVICE

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.

Sham acupunture treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

The Chinese University of Hong Kong, Prince of Wales Hospital

Shatin, Hong Kong, China

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Winnie C.W. Chu, MBChB, FRCR, MD, FHKAM

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 12, 2009
• First Posted: May 13, 2009
• Study Start: April 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: July 2, 2009

Record last verified: 2009-06

Locations

CN (1)