Clinical trial NCT02733276: Electroacupuncture vs. Sham Electroacupuncture for Treatment of Fatigue in Patients With Inflammatory Bowel Disease
Official title: Randomized Study : Electroacupuncture vs. Sham Electroacupuncture for Treatment of Fatigue in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatigue
Inflammatory Bowel Disease
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate the effectiveness of acupuncture in the treatment of fatigue in patients with inflammatory bowel disease (assessed by the FACIT-F scale).
timeFrame: 7 months
Secondary outcomes:
measure: Evaluate the effectiveness of acupuncture in the treatment of depression in patients with fatigue and inflammatory bowel disease (assessed by the Depression Beck scale).
timeFrame: 7 months
measure: Evaluate the effectiveness of acupuncture in the treatment of anxiety in patients with fatigue and inflammatory bowel disease (assessed by the Hamilton scale).
timeFrame: 7 months
measure: Evaluate the effectiveness of acupuncture in the treatment of sleepiness in patients with fatigue and inflammatory bowel disease (assessed by the Epworth scale).
timeFrame: 7 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Diana Horta
state: Barcelona
Study officials:
affiliation: Parc Tauli Hospital
name: Diana Horta
role: PRINCIPAL_INVESTIGATOR
References:
citation: Horta D, Lira A, Sanchez-Lloansi M, Villoria A, Teggiachi M, Garcia-Rojo D, Garcia-Molina S, Figuerola A, Esteve M, Calvet X. A Prospective Pilot Randomized Study: Electroacupuncture vs. Sham Procedure for the Treatment of Fatigue in Patients With Quiescent Inflammatory Bowel Disease. Inflamm Bowel Dis. 2020 Feb 11;26(3):484-492. doi: 10.1093/ibd/izz091.