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

NCT01261650 | Terminated Phase 4 DMC

• 1 other identifier: FIBRO 1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

widespread chronic pain, transcranial direct current stimulation, fibromyalgia

Outcome Measures

Primary Outcomes (1)

• Visual Analoge Scale

  Difference Baseline - after treatment

Secondary Outcomes (7)

• 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

• Visual analog scale

  1,2,3 months after treatment

• IL-6 ELISA

  baseline / after treatment / 1,2,3, months after treatment

Study Arms (2)

transcranial direct current stimulation

ACTIVE COMPARATOR

transcranial direct current stimulation of the primary motor cortex

Device: transcranial direct current stimulation

sham treatment

SHAM COMPARATOR

Device: sham treatment

Interventions

transcranial direct current stimulation DEVICE

transcranial direct current stimulation

sham treatment DEVICE

sham treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karl Landsteiner Institute of Remobilization and Functional Health: lead

Study Sites (1)

Karl Landsteiner Institute of Remobilisation and Functional Health

Vienna, Vienna, 1100, Austria

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Michael Quittan, PhD

  Karl Landsteiner Institute of Remobilisation and functional Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 16, 2010
• Study Start: December 1, 2010
• Last Updated: July 3, 2014

Record last verified: 2014-07

Locations

AU (1)