Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
This study is currently recruiting participants.
Verified July 2011 by Karl Landsteiner Institute of Remobilization and Functional Health
Sponsor:
Karl Landsteiner Institute of Remobilization and Functional Health
Information provided by:
Karl Landsteiner Institute of Remobilization and Functional Health
ClinicalTrials.gov Identifier:
NCT01261650
First received: December 14, 2010
Last updated: July 11, 2011
Last verified: July 2011
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01261650
Contacts
| Contact: Eva - Maria Strasser, MD | 00431601919993444 | eva-maris.strasser@wienkav.at |
| Contact: Markus Praschak, Master | 00431601919993455 | markus.praschak.ext@wienkav.at |
Locations
| Austria | |
| Karl Landsteiner Institute of Remobilisation and Functional Health | Recruiting |
| Vienna, Austria, 1100 | |
| Contact: Eva Maria Strasser, MD 00431601919993444 eva-maria.strasser@wienkav.at | |
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 11, 2011 |
| 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 May 23, 2013