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FibromyalgiaNCT03084094

Neuromodulation and Its Therapeutic Potentiality in Different Populations

A study testing Transcranial Direct Current Stimulation in people with Fibromyalgia, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Fibromyalgia
What is being tested?
Transcranial Direct Current Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteBrazil
Study dates
17 Oct 2016to 28 Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female gender aged from 18 to 65 year old, having a clinical diagnosis of Fibromyalgia given by a rheumatologist.

Who cannot join

  • Non-regulated psychiatric disorders (bipolar, main depression, schizophrenia)
  • Performing other types of treatment during the research
  • Performing physical activities

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Hospital Universitário Onofre Lopes

    Natal, Rio Grande do Norte

Other trials in Brazil

About this study

Official title: Transcranial Direct Current Stimulation and Its Therapeutic Potentiality in Different Populations

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.

Read more

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.

Conditions
Fibromyalgia
Keywords
Fibromyalgia, tDCS
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03084094
Study groupRoleWhat they receive
M1ExperimentalTranscranial direct current Stimulation in primary motor cortex
Receives: Device: Transcranial Direct Current Stimulation
DLPFCExperimentalTranscranial direct current Stimulation in the dorsolateral pre-frontal cortex
Receives: Device: Transcranial Direct Current Stimulation
ShamSham comparatorsham stimulation
Receives: Device: Transcranial Direct Current Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline Pain at 2 weeks

    Diary of Pain

    Measured: 1 week prior to treatment (Baseline) and 1 week during treatment

  2. Change from Baseline Pain at 5 weeks

    Pressure Pain Threshold and Tolerance by an algometer

    Measured: 1 week prior to treatment, day 1 of treatment, last day of treatment (day 5), 7 days, 14 days and 21 days after treatment

  3. Change from Baseline Pain at 5 weeks

    Visual Analogue Scale

    Measured: 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 outcomes (4)
  1. Functional Capacity

    Fibromyalgia Impact Questionnaire

    Measured: 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment

  2. Mood

    Beck Depression Inventory

    Measured: 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment

  3. Anxiety

    Hamilton Anxiety Scale

    Measured: 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment

  4. Positive and negative affect

    Positive and Negative Affect Schedule

    Measured: 1 week prior to treatment, last day of treatment (day 5),7 days, 14 days and 21 days after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2017
  2. Study start17 Oct 2016
  3. Primary completion28 Feb 2018
  4. Study completion28 Feb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03084094
Sponsor's protocol ID
tDCS in fibromyalgia
Status last verified
Jul 2018
First submitted
7 Mar 2017
Last updated
6 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation in people with Fibromyalgia, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline Pain at 2 weeks (time frame: 1 week prior to treatment (Baseline) and 1 week during treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.

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