Electroacupuncture vs. Sham Electroacupuncture for Treatment of Fatigue in Patients With Inflammatory Bowel Disease

Study Overview
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Brief Summary
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Fatigue is a common symptom in inflammatory bowel diseaseI and persists despite clinical remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale. Acupuncture has been shown useful in the treatment of fatigue in various chronic diseases. This study evaluates the effect of electroacupuncture in the treatment of fatigue in patients with quiescent inflammatory bowel disease. Patients with inflammatory bowel disease and severe fatigue (FACIT-F score <38) who agree to participate in the study will be randomized to three different treatments: electroacupuncture vs. sham electroacupuncture vs. control group.

Detailed Description
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Fatigue is a common symptom in inflammatory bowel disease and persists despite clinical remission. Fatigue in patients with chronic diseases can be objectified by the FACIT-F scale. Acupuncture has been shown useful in the treatment of fatigue in various chronic diseases. This study evaluates the effect of electroacupuncture in the treatment of fatigue in patients with quiescent inflammatory bowel disease. Patients with inflammatory bowel disease and severe fatigue (FACIT-F score < 38) who agree to participate in the study will be randomized to three different treatments: electroacupuncture vs. sham electroacupuncture vs. group control. Treatment consists of a total of 9 sessions / patient (2 sessions / week the first week and then one session / week for two months). During and after treatment, patients fill in questionnaires to assess fatigue, anxiety, depression, quality of life in inflammatory bowel disease and sleepiness. Those patients who do not improve with the initial treatment or present a recurrence of fatigue (defined as a decrease of at least 4 points in the FACIT-F score) then receive crossover treatment for 8 more weeks (total of 9 new sessions). The control group fill in questionnaires in the same periods as patients who receive active treatment. These patients (control group) receive electroacupuncture sessions(total of 9 sessions) in a second period.

Official Title
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Randomized Study : Electroacupuncture vs. Sham Electroacupuncture for Treatment of Fatigue in Patients With Inflammatory Bowel Disease

Conditions
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Fatigue, Inflammatory Bowel Disease

Intervention / Treatment
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* Other: electroacupuncture
* Other: Sham: Electroacupuncture sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with inflammatory bowel disease and fatigue in patients over 18 years Presence of continued fatigue determined in two consecutive scores and stability of the symptoms of fatigue according to the patient's opinion . Inflammatory bowel disease diagnosed at least 6 months before the study (diagnosed by clinical, laboratory , endoscopic and histological criteria) . Written informed consent Exclusion Criteria: Patients who are participating in other clinical studies. Associated tumor disease . Pregnant or breast feeding women . Anemia Hemoglobin determined under 12 in women and 14 in men. Patients who have suffered minor adverse reactions to acupuncture. Prior Acupuncture.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electroacupuncture<br>Using electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes. Acupoints are: 6 needles in each lower limb, 8 abdominal, 3 in upper extremity and 3 on the front | Other: electroacupuncture<br>* Electroacupuncture: Using an electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes.<br>|
| Sham Comparator: Electroacupuncture sham<br>Using electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes. Acupoints are: needles on each forearm on nonselective points | Other: Sham: Electroacupuncture sham<br>* Sham comparator (Electroacupuncture sham): Using an electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes.<br>|
| No Intervention: Control<br>Initially no intervention. In a second period in this group we will perform EAP | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of acupuncture in the treatment of fatigue in patients with inflammatory bowel disease (assessed by the FACIT-F scale). | Assessed by the FACIT-F scale | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the effectiveness of acupuncture in the treatment of depression in patients with fatigue and inflammatory bowel disease (assessed by the Depression Beck scale). | assessed by the Depression Beck scale | 7 months | 
| Evaluate the effectiveness of acupuncture in the treatment of anxiety in patients with fatigue and inflammatory bowel disease (assessed by the Hamilton scale). | assessed by the Hamilton scale | 7 months | 
| Evaluate the effectiveness of acupuncture in the treatment of sleepiness in patients with fatigue and inflammatory bowel disease (assessed by the Epworth scale). | assessed by the Epworth scale | 7 months |