Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome

July 2, 2014 updated by: Karl Landsteiner Institute of Remobilization and Functional Health
Fibromyalgia is a common chronic pain syndrome characterized by bad treatable chronic widespread pain present at a similar level for at least 3 months. The aim of this study is to examine if 3 weeks of transcranial direct current stimulation is a suitable therapy to reduce chronic pain.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 4

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

  • Austria
      • Vienna, Austria, 1100
        • Karl Landsteiner Institute of Remobilisation and Functional Health

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

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who have an established diagnosis of fibromyalgia according to the 1990 criteria of the "American College of Rheumatology"
  • Symptoms have been present at a similar level for at least 3 months
  • Stable medication for at least 2 months
  • visual analog scale ≥ 3 (0=no pain; 10=worst possible pain)
  • The patient does not have a disorder that would otherwise explain the pain

Exclusion Criteria:

  • Alcohol/substance abuse
  • Pregnancy
  • Neuropsychiatric disorders
  • Metal implants near stimulation area
  • Cardiac pace maker
  • Local injuries
  • Inflammatory rheumatic disease
  • Acute tumor
  • Acute fracture
  • Well-defined neuropathic induced pain

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: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: transcranial direct current stimulation
transcranial direct current stimulation of the primary motor cortex
Device: transcranial direct current stimulation
Sham Comparator: sham treatment
Device: sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analoge Scale
Time Frame: Difference Baseline - after treatment
Difference Baseline - after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of Life - SF-36
Time Frame: baseline / after treatment / 1 , 2, 3 months after treatment
baseline / after treatment / 1 , 2, 3 months after treatment
Fibromyalgia Impact Questionaire
Time Frame: baseline / after treatment / 1,2,3, months after treatment
baseline / after treatment / 1,2,3, months after treatment
IL-10 ELISA
Time Frame: baseline / after treatment / 1,2,3, months after treatment
baseline / after treatment / 1,2,3, months after treatment
Visual analog scale
Time Frame: 1,2,3 months after treatment
1,2,3 months after treatment
IL-6 ELISA
Time Frame: baseline / after treatment / 1,2,3, months after treatment
baseline / after treatment / 1,2,3, months after treatment
IL-4 ELISA
Time Frame: baseline / after treatment / 1,2,3, months after treatment
baseline / after treatment / 1,2,3, months after treatment
TNF-alpha ELISA
Time Frame: baseline / after treatment / 1,2,3, months after treatment
baseline / after treatment / 1,2,3, months after treatment

Collaborators and Investigators

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

Sponsor

Karl Landsteiner Institute of Remobilization and Functional Health

Investigators

  • Principal Investigator: Michael Quittan, PhD, Karl Landsteiner Institute of Remobilisation and Functional Health

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

December 1, 2010

Study Registration Dates

First Submitted

December 14, 2010

First Submitted That Met QC Criteria

December 15, 2010

First Posted (Estimate)

December 16, 2010

Study Record Updates

Last Update Posted (Estimate)

July 3, 2014

Last Update Submitted That Met QC Criteria

July 2, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIBRO 1

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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