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

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01261650
• Other study ID #: FIBRO 1
• Status: Terminated
• Phase: Phase 4
• First received: December 14, 2010
• Last updated: July 2, 2014
• Start date: December 2010

Study information

• Verified date: July 2014
• Source: Karl Landsteiner Institute of Remobilization and Functional Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Device:
• transcranial direct current stimulation

• sham treatment

Locations

Country	Name	City	State
Austria	Karl Landsteiner Institute of Remobilisation and Functional Health	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Karl Landsteiner Institute of Remobilization and Functional Health

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analoge Scale		Difference Baseline - after treatment	No
Secondary	Quality of Life - SF-36		baseline / after treatment / 1 , 2, 3 months after treatment	No
Secondary	Fibromyalgia Impact Questionaire		baseline / after treatment / 1,2,3, months after treatment	No
Secondary	IL-10 ELISA		baseline / after treatment / 1,2,3, months after treatment	No
Secondary	Visual analog scale		1,2,3 months after treatment	No
Secondary	IL-6 ELISA		baseline / after treatment / 1,2,3, months after treatment	No
Secondary	IL-4 ELISA		baseline / after treatment / 1,2,3, months after treatment	No
Secondary	TNF-alpha ELISA		baseline / after treatment / 1,2,3, months after treatment	No