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

August 8, 2017 updated by: Diana Horta-Sangenis, Corporacion Parc Tauli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Diana Horta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Other: electroacupuncture
Electroacupuncture: Using an electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes.
Sham Comparator: 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
Other: Sham: Electroacupuncture sham
Sham comparator (Electroacupuncture sham): Using an electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes.
No Intervention: Control
Initially no intervention. In a second period in this group we will perform EAP

What is the study measuring?

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).
Time Frame: 7 months
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).
Time Frame: 7 months
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).
Time Frame: 7 months
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).
Time Frame: 7 months
assessed by the Epworth scale
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Investigators

  • Principal Investigator: Diana Horta, Parc Taulí Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

March 5, 2016

First Submitted That Met QC Criteria

April 8, 2016

First Posted (Estimate)

April 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014067

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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