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

NCT02733276 | Completed

• 1 other identifier: 2014067
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Fatigue; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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 anxiety in patients with fatigue and inflammatory bowel disease (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).

  7 months

Study Arms (3)

Electroacupuncture

EXPERIMENTAL

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 sham

SHAM COMPARATOR

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

Control

NO INTERVENTION

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

Interventions

electroacupuncture OTHER

Electroacupuncture: Using an electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes.

Electroacupuncture

Sham: Electroacupuncture sham OTHER

Sham comparator (Electroacupuncture sham): Using an electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes.

Electroacupuncture sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corporacion Parc Tauli: lead

Study Sites (1)

Diana Horta

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (1)

• 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.

  PMID: 31091322 DERIVED

MeSH Terms

Conditions

Fatigue; Inflammatory Bowel Diseases

Interventions

Electroacupuncture

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Acupuncture Therapy; Complementary Therapies; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Transcutaneous Electric Nerve Stimulation; Analgesia; Anesthesia and Analgesia; Anesthesia

Study Officials

• Diana Horta

  Parc Tauli Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician

Study Record Dates

• First Submitted: March 5, 2016
• First Posted: April 11, 2016
• Study Start: January 1, 2016
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: August 9, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)