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

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01261650

Enrollment

Registered

2010-12-16

Start date

2010-12-31

Completion date

Unknown

Last updated

2014-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Keywords

widespread chronic pain, transcranial direct current stimulation, fibromyalgia

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.

Interventions

DEVICEtranscranial direct current stimulation

DEVICEsham treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Visual Analoge Scale	Difference Baseline - after treatment

Secondary

Measure	Time frame
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
Quality of Life - SF-36	baseline / after treatment / 1 , 2, 3 months after treatment
IL-4 ELISA	baseline / after treatment / 1,2,3, months after treatment
TNF-alpha ELISA	baseline / after treatment / 1,2,3, months after treatment
IL-6 ELISA	baseline / after treatment / 1,2,3, months after treatment

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026