Back to resultsInfluence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
Primary Purpose
Fibromyalgia
Status
Terminated
Phase
Phase 4
Locations
Austria
Study Type
Interventional
Intervention
transcranial direct current stimulation
sham treatment
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia focused on measuring widespread chronic pain, transcranial direct current stimulation, fibromyalgia
Eligibility 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
Sites / Locations
- Karl Landsteiner Institute of Remobilisation and Functional Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
transcranial direct current stimulation
sham treatment
Arm Description
transcranial direct current stimulation of the primary motor cortex
Outcomes
Primary Outcome Measures
Visual Analoge Scale
Secondary Outcome Measures
Quality of Life - SF-36
Fibromyalgia Impact Questionaire
IL-10 ELISA
Visual analog scale
IL-6 ELISA
IL-4 ELISA
TNF-alpha ELISA
Full Information
NCT ID
NCT01261650
First Posted
December 14, 2010
Last Updated
July 2, 2014
Sponsor
Karl Landsteiner Institute of Remobilization and Functional Health
1. Study Identification
Unique Protocol Identification Number
NCT01261650
Brief Title
Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
Official Title
Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
There could not be enough patients recruited
Study Start Date
December 2010 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Karl Landsteiner Institute of Remobilization and Functional Health
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
widespread chronic pain, transcranial direct current stimulation, fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
transcranial direct current stimulation
Arm Type
Active Comparator
Arm Description
transcranial direct current stimulation of the primary motor cortex
Arm Title
sham treatment
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
transcranial direct current stimulation
Intervention Type
Device
Intervention Name(s)
sham treatment
Primary Outcome Measure Information:
Title
Visual Analoge Scale
Time Frame
Difference Baseline - after treatment
Secondary Outcome Measure Information:
Title
Quality of Life - SF-36
Time Frame
baseline / after treatment / 1 , 2, 3 months after treatment
Title
Fibromyalgia Impact Questionaire
Time Frame
baseline / after treatment / 1,2,3, months after treatment
Title
IL-10 ELISA
Time Frame
baseline / after treatment / 1,2,3, months after treatment
Title
Visual analog scale
Time Frame
1,2,3 months after treatment
Title
IL-6 ELISA
Time Frame
baseline / after treatment / 1,2,3, months after treatment
Title
IL-4 ELISA
Time Frame
baseline / after treatment / 1,2,3, months after treatment
Title
TNF-alpha ELISA
Time Frame
baseline / after treatment / 1,2,3, months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Quittan, PhD
Organizational Affiliation
Karl Landsteiner Institute of Remobilisation and functional Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karl Landsteiner Institute of Remobilisation and Functional Health
City
Vienna
ZIP/Postal Code
1100
Country
Austria
12. IPD Sharing Statement
Learn more about this trial
Influence of Transcranial Direct Current Stimulation of the Primary Motor Cortex on Pain Sensation in Patients Suffering From Fibromyalgia Syndrome
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