Randomized Study : Electroacupuncture vs. Sham Electroacupuncture for Treatment of Fatigue in Patients With Inflammatory Bowel Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Evaluate the effectiveness of acupuncture in the treatment of fatigue in patients with inflammatory bowel disease (assessed by the FACIT-F scale).
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Electroacupuncture
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
Intervention: electroacupuncture (Other)
Electroacupuncture sham
Using electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes. Acupoints are: needles on each forearm on nonselective points
Intervention: Sham: Electroacupuncture sham (Other)
Control
Initially no intervention. In a second period in this group we will perform EAP
Outcomes
Primary Outcomes
Evaluate the effectiveness of acupuncture in the treatment of fatigue in patients with inflammatory bowel disease (assessed by the FACIT-F scale).
Time Frame: 7 months
Assessed by the FACIT-F scale
Secondary Outcomes
- Evaluate the effectiveness of acupuncture in the treatment of depression in patients with fatigue and inflammatory bowel disease (assessed by the Depression Beck 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).(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).(7 months)
Investigators
Diana Horta-Sangenis
Resident Physician
Corporacion Parc Tauli