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

NCT ID: NCT01261650

Last Updated: 2014-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Brief Summary

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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

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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transcranial direct current stimulation

transcranial direct current stimulation of the primary motor cortex

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

sham treatment

Group Type SHAM_COMPARATOR

sham treatment

Intervention Type DEVICE

Interventions

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transcranial direct current stimulation

Intervention Type DEVICE

sham treatment

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karl Landsteiner Institute of Remobilization and Functional Health

OTHER

Sponsor Role lead

Responsible Party

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Institute of Physical Medicine and Rehabilitation

Principal Investigators

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Michael Quittan, PhD

Role: PRINCIPAL_INVESTIGATOR

Karl Landsteiner Institute of Remobilisation and functional Health

Locations

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Karl Landsteiner Institute of Remobilisation and Functional Health

Vienna, Vienna, Austria

Site Status

Countries

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Austria

Other Identifiers

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FIBRO 1

Identifier Type: -

Identifier Source: org_study_id

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