Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With fMRI

Study Overview
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Brief Summary
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The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of Crohn's disease. Meanwhile, the investigators aim to evaluate the efficacy by functional magnetic resonance imaging.

Detailed Description
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The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of Crohn's disease. meanwhile, the investigators aim to evaluate the efficacy by functional magnetic resonance imaging. Through treating quiescent Crohn's disease by electroacupuncture or moxibustion therapies for 12 weeks, Compare the different brain activation by the different therapies and observe the correlation between brain activation and efficacy.

Official Title
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Efficacy of Acupuncture and Moxibustion Treatment in Patients With Quiescent Crohn's Disease:Evaluation With Functional Magnetic Resonance Imaging(fMRI)

Conditions
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Crohn's Disease, CAM

Intervention / Treatment
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* Other: electroacupuncture
* Other: moxibustion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-50 years; right-handed; clinical remission (Crohn's Disease Activity Index [CDAI]≤150) for at least 6 months prior to the study; C-reactive protein(CRP)<10 mg/l; erythrocyte sedimentation rate (ESR) <20 mm/h signing awritten informed consent form. Exclusion Criteria: use of corticosteroids and psychotropic medications in the previous 30 days; current or prior history of neurological or psychiatric disease based on physicians' examination and questionnaires; current or prior history of neurosurgery, head injury, cerebrovascular insult, or brain trauma involving loss of consciousness; learning disability; claustrophobia; presence of metallic implants in the body; being pregnant or during lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EA group<br>Electroacupuncture group | Other: electroacupuncture<br>* Patients receive electroacupuncture for 30 minutes with a stimulation frequency of 2 /100 Hz and a stimulation intensity varying from 0.1 to 1.0 mA.3 times per week,the duration is 12 weeks.<br>* Other names: acupuncture;Other: moxibustion<br>* patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.<br>* Other names: herbs-partitioned moxibustion;|
| Experimental: MOX group<br>Herbs-partitioned moxibustion group | Other: electroacupuncture<br>* Patients receive electroacupuncture for 30 minutes with a stimulation frequency of 2 /100 Hz and a stimulation intensity varying from 0.1 to 1.0 mA.3 times per week,the duration is 12 weeks.<br>* Other names: acupuncture;Other: moxibustion<br>* patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.<br>* Other names: herbs-partitioned moxibustion;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CDAI | Crohn's Disease Activity Index | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI | Brain activiation tested by BOLD fMRI | 1 year | 
| IBDQ | Inflammatory Bowel Disease Questionnaire | 1 year | 
| Inflammatory factors | Intestinal mucosa of IL-6,IL-17,IL-23,etc | 1 and a half years | 
| Neurotransmitter | 5-HT,DA,etc | 1 and a half years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's disease, acupuncture, moxibustion, fMRI, Gut