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

This study has been terminated.
(There could not be enough patients recruited)
Sponsor:
Information provided by:
Karl Landsteiner Institute of Remobilization and Functional Health
ClinicalTrials.gov Identifier:
NCT01261650
First received: December 14, 2010
Last updated: July 2, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Fibromyalgia
Device: transcranial direct current stimulation
Device: sham treatment
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome

Resource links provided by NLM:


Further study details as provided by Karl Landsteiner Institute of Remobilization and Functional Health:

Primary Outcome Measures:
  • Visual Analoge Scale [ Time Frame: Difference Baseline - after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life - SF-36 [ Time Frame: baseline / after treatment / 1 , 2, 3 months after treatment ] [ Designated as safety issue: No ]
  • Fibromyalgia Impact Questionaire [ Time Frame: baseline / after treatment / 1,2,3, months after treatment ] [ Designated as safety issue: No ]
  • IL-10 ELISA [ Time Frame: baseline / after treatment / 1,2,3, months after treatment ] [ Designated as safety issue: No ]
  • Visual analog scale [ Time Frame: 1,2,3 months after treatment ] [ Designated as safety issue: No ]
  • IL-6 ELISA [ Time Frame: baseline / after treatment / 1,2,3, months after treatment ] [ Designated as safety issue: No ]
  • IL-4 ELISA [ Time Frame: baseline / after treatment / 1,2,3, months after treatment ] [ Designated as safety issue: No ]
  • TNF-alpha ELISA [ Time Frame: baseline / after treatment / 1,2,3, months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: December 2010
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01261650

Locations
Austria
Karl Landsteiner Institute of Remobilisation and Functional Health
Vienna, Austria, 1100
Sponsors and Collaborators
Karl Landsteiner Institute of Remobilization and Functional Health
Investigators
Principal Investigator: Michael Quittan, PhD Karl Landsteiner Institute of Remobilisation and functional Health
  More Information

No publications provided

Responsible Party: Karl Landsteiner Institute of Remobilization and Functional Health, Institute of Physical Medicine and Rehabilitation
ClinicalTrials.gov Identifier: NCT01261650     History of Changes
Other Study ID Numbers: FIBRO 1
Study First Received: December 14, 2010
Last Updated: July 2, 2014
Health Authority: Austria: Ethikkommission

Keywords provided by Karl Landsteiner Institute of Remobilization and Functional Health:
widespread chronic pain, transcranial direct current stimulation, fibromyalgia

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Stress, Psychological
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 19, 2014