Effect of Acupuncture on Patients With Crohn's Disease in Remission

Study Overview
=================
Brief Summary
-----------------
To observe the therapeutic effect of acupuncture on Crohn's disease in remission and its influence of brain functional activity

Detailed Description
-----------------
Effect of acupuncture on symptoms （functional gastrointestinal symptoms, Fatigue, insomnia, depression, anxiety and perceived stress）of CD Effect of acupuncture on brain functional activity of CD

Official Title
-----------------
Effect of Acupuncture on Crohn's Disease Via the Regulation of Trp-kyn Metabolism in Brain-gut Axis

Conditions
-----------------
Crohn Disease, Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Other: acupuncture
* Other: Sham acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 16-70; patients in remission (CDAI < 150); patients were not taking medication or were only taking one or more of the following drugs: [prednisone ≤15mg/d, azathioprine (≤1mg/kg/d), methotrexate (≤15mg/w) or mesalazine (≤4g/d)] and prednisone was used for at least 1 month, while azathioprine, methotrexate or mesalazine was used for at least 3 months; those who did not use TNF alpha and other preparations within 3 months before entering the study; those who have never experienced acupuncture; patients signing informed consent. Exclusion Criteria: patients who are recently pregnant or in pregnancy or lactation; patients with serious organic diseases; patients diagnosed as psychosis; patients who take antibiotics, probiotics, traditional Chinese medicine and other drugs at the same time, or who suffer from multiple diseases and need to take other drugs for a long time, and may affect the observation of the efficacy of this trial; severe skin diseases (such as erythema nodosum, pyoderma gangrenosum, etc.), eye diseases (such as iritis, uveitis, etc.), thromboembolic diseases and other serious extraintestinal manifestations; there are serious intestinal fistula, abdominal abscess, intestinal stenosis and obstruction, perianal abscess, gastrointestinal hemorrhage, intestinal perforation and other complications; patients with short bowel syndrome who have undergone abdominal or gastrointestinal surgery in the past half a year; there are skin diseases or defects in the selected area of acupuncture and moxibustion that cannot be performed.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture group<br>Receiving acupuncture and moxibustion | Other: acupuncture<br>* Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion.<br>|
| Sham Comparator: sham acupuncture group<br>Receiving sham acupuncture and sham moxibustion | Other: Sham acupuncture<br>* Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Fatigue Inventory (BFI-C) | The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Fatigue Inventory (BFI-C) | The mean change in BFI-C from baseline. The higher the score, the worse the condition. Greater than 0, the upper limit is 90. | Week 24,52 | 
| The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | The mean change in FACIT-F from baseline. The higher the score, the worse the condition. The score range from 0 to 52. | Week 12, 24,52 | 
| Crohn's disease activity index （CDAI）score | The mean change in CDAI from baseline. The higher the score, the worse the condition. Greater than 0, no upper limit. | Week 12, 24,36,48,52 | 
| Inflammatory bowel disease questionnaire (IBDQ) | The mean change in IBDQ from baseline. The higher the score, the worse the condition.The score is range from 32 to 224. | Week 12, 24 and 52 | 
| Hospital anxiety and depression scale (HADS) | The mean change in HADS from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21. | Week 12, 24 and 52 | 
| Patient Health Questionnaire Depression Scale (PHQ-9) | The mean change in PHQ-9 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 27. | Week 12, 24 and 52 | 
| Generalized Anxiety Disorder (GAD-7) | The mean change in gad-7 from baseline. The higher the score, the more serious the disease. The depression and anxiety score is range from 0 to 21. | Week 12, 24 and 52 | 
| The proportion of recurrences | Defined as CDAI > 150 and increase ≥ 70 points or need to adjust drug to control disease condition. | Week 52 | 
| Brain functional and structural changes | measured by functional MRI | Week 12 | 
| Colonoscopy or small bowel MR evaluation | measured by colonoscopy (SES-CD score) or small bowel MR (MaRIA score) | Week 52 | 
| Laboratory tests | Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR) and platelet count (PLT) | Week 12, 24, 36, and 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acupuncture, Crohn's disease, brain functional activity