Fibromyalgia Clinical Trial
Official title:
Transcranial Direct Current Stimulation and Its Therapeutic Potentiality in Different Populations
Verified date | July 2018 |
Source | Universidade Federal do Rio Grande do Norte |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
One of the big challenges faced by researchers who act in rehabilitation science is the
capacity to dispose integrative approaches for its utilization in clinical practice. The
border profile of a physiotherapy researcher is to be in front of applied research
amplification in experimental integrative approaches, involving the study of behavioral and
physiological variables.
The rehabilitation process transcends the systems physiology and encompasses the cognitive
behavioral feature of being adapted to the environment that surround us. It is now known by
the scientific rehabilitation community the necessity for evidence based therapies and even
more, therapeutic innovation. In both conditions, of health and illness, various options to
use integrative approaches are today available in physiotherapy, including behavioral and
physiological profiles of the individuals during physical activities, response to stress and
in the field of chronic pain.
It is in the clinical routine of numerous rehabilitation centers the treatment of diseases
that causes pain, being the leading figure in a physiotherapist work process. The innovative
study of resources that can alter the pain state of this patients becomes primordial for
routine clinical use, low cost and easy to apply. The therapeutic treatment for pain offered
by a physiotherapist need new investigative options based in evidences from the association
between the neuronal, behavioral and physiological responses where the brain is the central
organ of this regulation. In this context, become increasingly more necessary the
construction of investigative approaches in the purpose of reaching the clinical practice, in
a reduced time lapse, once the great volume of information produced globally does not impact
in short or medium term in new therapeutic recommendations.
Among the various chronic painful entities, it is presented the fibromyalgia (FM), painful
diabetic polyneuropathy and primary dysmenorrhea because of its painful pathogenic complexity
and its limited therapeutic against pain in rehabilitation process. The 3 painful entities
presents the central nervous system as main participant of neurogenesis and maintenance of
the painful state.
It is primordial importance that rehabilitation science improve methods of non invasive brain
neuromodulation that allows, through excitation or inhibition of specific cortical areas in
order to produce pain inhibition, providing a simple and low cost treatment to clinical
routine. Technological advances and non invasive techniques to modulate brain function has
been developed, among which transcranial direct current stimulation (tDCS) stands out.
Basically, electrodes are placed in targeted brain regions that you want to stimulate or
inhibit. Posteriorly, is applied a continuous electric current (0,4 - 2 mA) for a 3-20
minutes period, in order to modify cortical excitability. The stimulus of the anodic current
increases cortical excitability whereas the stimulus of the cathodic current has an
inhibitory effect.
Few are the research groups that address the issue of fibromyalgia, painful diabetic
polyneuropathy and primary dysmenorrhea and the application of tDCS as research focus, being
a border area for rehabilitation science and great potential in clinical use. Preliminary
studies associates the use of tDCS with the decrease of painful state, however an approach of
physical function and behavioral results needs greater investigation.
The purpose of the presented project is to present the tDCS as a new modality in physical
rehabilitation for the patient with chronic pain of the 3 entities mentioned above. The study
proposal is to present behavioral, social and physical results of tDCS application in this
patients, suggesting a better quality of life and functionality of the individual.
Status | Completed |
Enrollment | 45 |
Est. completion date | February 28, 2018 |
Est. primary completion date | February 28, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Female gender aged from 18 to 65 year old, having a clinical diagnosis of Fibromyalgia given by a rheumatologist. Exclusion Criteria: - Non-regulated psychiatric disorders (bipolar, main depression, schizophrenia) - Performing other types of treatment during the research - Performing physical activities |
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Universitário Onofre Lopes | Natal | Rio Grande Do Norte |
Lead Sponsor | Collaborator |
---|---|
Universidade Federal do Rio Grande do Norte |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline Pain at 2 weeks | Diary of Pain | 1 week prior to treatment (Baseline) and 1 week during treatment | |
Primary | Change from Baseline Pain at 5 weeks | Pressure Pain Threshold and Tolerance by an algometer | 1 week prior to treatment, day 1 of treatment, last day of treatment (day 5), 7 days, 14 days and 21 days after treatment | |
Primary | Change from Baseline Pain at 5 weeks | Visual Analogue Scale | 1 week prior to treatment, day 1 of treatment, last day of treatment (day 5), 7 days, 14 days and 21 days after treatment | |
Secondary | Functional Capacity | Fibromyalgia Impact Questionnaire | 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment | |
Secondary | Mood | Beck Depression Inventory | 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment | |
Secondary | Anxiety | Hamilton Anxiety Scale | 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment | |
Secondary | Positive and negative affect | Positive and Negative Affect Schedule | 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment |
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