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 Health

Status and phase: Terminated; Phase 4

Conditions: Fibromyalgia

Treatments: Device: sham treatment; Device: transcranial direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT01261650

FIBRO 1

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups

transcranial direct current stimulation

Active Comparator group

Description:

transcranial direct current stimulation of the primary motor cortex

Treatment:

Device: transcranial direct current stimulation

sham treatment

Sham Comparator group

Treatment:

Device: sham treatment