A Pilot Study on the Effect of Electroacupuncture on Functional Brain Mapping in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Sensory and pain thresholds as determined by rectal barostat
研究概览
简要总结
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.
详细描述
All patients will be evaluated for study eligibility at visit 1 (baseline). Baseline assessment includes the following items:
- Global symptom assessment: Based on Rome III Working Group recommendation, a clinical outcome response measure is used in which patients are required to report "improved", "the same" or "worsened" to the question "Do you have adequate symptom relief in the past 7 days?"
- Individual IBS symptoms: The individual IBS symptom (pain/discomfort, bloating, constipation, and diarrhea) as perceived by patients will be scored in a 5-point scale (0=none or asymptomatic; 1=mild with no limitation of normal activities; 2=moderate with limitation of some normal activities; 3=intense and unable to carry out most normal activities; 4=incapacitating symptom that are intolerable and unable to carry out all normal activities).
- Syndrome of Chinese medicine: The syndrome of IBS patients will be recorded and analyzed based on the Chinese medicine theories. These symptoms involving: fatigue, appetite, sense of mouth, quality of sleep, the coating of tongue, pulse, etc.
- Quality of life (QOL) assessment: A disease-specific questionnaire- IBS Quality of Life Scale (Chinese) will be used for assessment of QOL in response to treatment. The questionnaire was locally validated, and was recently developed by our group.
- Rectal barostat: The patients will be evaluated for the sensory threshold and maximum tolerable threshold of rectum in response to balloon distension of rectum before the acupuncture treatment.
At visit 2, eligible patients will be randomly assigned to either (1) electroacupuncture or (2) sham electroacupuncture. During the treatment, the patient will receive fMRI to evaluate the cerebral cortical activity in response to balloon distension of rectum. Three sets of real-time functional brain mapping using fMRI will be performed during rectal balloon distensions at maximum tolerable pressure at the following time points:
- 10 minutes after acupuncture needle insertion before delivery of electrical stimulation
- 15 minutes after electrical stimulation begins (electrical stimulation continues during MRI)
- Immediately after electrical stimulation stops before removal of acupuncture needle
Rectal barostat:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Sensory and pain thresholds as determined by rectal barostat
时间窗: At baseline study visit
Degree of cortical activation as determined by functional MRI
时间窗: At study visit 2
次要结局
未报告次要终点