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

Karl Landsteiner Institute of Remobilization and Functional Health1 site in 1 country50 target enrollmentDecember 2010

ConditionsFibromyalgia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Karl Landsteiner Institute of Remobilization and Functional Health
Enrollment: 50
Locations: 1
Primary Endpoint: Visual Analoge Scale
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Karl Landsteiner Institute of Remobilization and Functional Health

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

Outcomes

Primary Outcomes

Visual Analoge Scale

Time Frame: Difference Baseline - after treatment

Secondary Outcomes

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