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

Phase 4

Terminated

• Conditions: Fibromyalgia
• Interventions: Device: transcranial direct current stimulation; Device: sham treatment

• Registration Number: NCT01261650
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-14
• Study First Submitted QC: 2010-12-15
• Study First Posted: 2010-12-16
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-02
• Last Update Posted: 2014-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
transcranial direct current stimulation	transcranial direct current stimulation	transcranial direct current stimulation of the primary motor cortex
sham treatment	sham treatment	-

Primary Outcome Measures

Name	Time	Method
Visual Analoge Scale	Difference Baseline - after treatment

Secondary Outcome Measures

Name	Time	Method
IL-6 ELISA	baseline / after treatment / 1,2,3, months after treatment
Visual analog scale	1,2,3 months after treatment
Quality of Life - SF-36	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
TNF-alpha ELISA	baseline / after treatment / 1,2,3, months after treatment
IL-4 ELISA	baseline / after treatment / 1,2,3, months after treatment

Trial Locations

Locations (1)

Karl Landsteiner Institute of Remobilisation and Functional Health; 🇦🇹 Vienna, Austria