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

Corporacion Parc Tauli

Status: Completed

Conditions: Inflammatory Bowel Disease; Fatigue

Treatments: Other: Sham: Electroacupuncture sham; Other: electroacupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT02733276

2014067

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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54 participants in 3 patient groups

Electroacupuncture

Experimental group

Description:

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

Treatment:

Other: electroacupuncture

Electroacupuncture sham

Sham Comparator group

Description:

Using electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes. Acupoints are: needles on each forearm on nonselective points

Treatment:

Other: Sham: Electroacupuncture sham

Control

No Intervention group

Description:

Initially no intervention. In a second period in this group we will perform EAP