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

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ClinicalTrials.gov Identifier: NCT01261650
Recruitment Status : Terminated (There could not be enough patients recruited)
First Posted : December 16, 2010
Last Update Posted : July 3, 2014
Sponsor:
Information provided by:
Karl Landsteiner Institute of Remobilization and Functional Health

Brief Summary:
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 or disease Intervention/treatment Phase
Fibromyalgia Device: transcranial direct current stimulation Device: sham treatment Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Visual Analoge Scale [ Time Frame: Difference Baseline - after treatment ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: December 16, 2010    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: July 2014

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
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases