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

Not Applicable

Completed

• Conditions: CAM; Crohn's Disease
• Interventions: Other: electroacupuncture; Other: moxibustion

• Registration Number: NCT01696838
• Lead Sponsor: Shanghai Institute of Acupuncture, Moxibustion and Meridian

Brief Summary

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

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.

Study Timeline

• Status Verified: 2012-09
• Study Start: 2012-09
• Study First Submitted: 2012-09-25
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-01
• Primary Completion: 2014-04
• Study Completion: 2014-11
• Last Update Submitted: 2016-09-02
• Last Update Posted: 2016-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOX group	moxibustion	Herbs-partitioned moxibustion group
EA group	moxibustion	Electroacupuncture group
MOX group	electroacupuncture	Herbs-partitioned moxibustion group
EA group	electroacupuncture	Electroacupuncture group

Primary Outcome Measures

Name	Time	Method
CDAI	1 year	Crohn's Disease Activity Index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shanghai Institute of Acupuncture-Moxibustion and Merdian; 🇨🇳 Shanghai, Shanghai, China