Clinical trial NCT02993952: tDCS and Its Therapeutic Effects in CK Fever
Official title: Transcranial Direct Current Stimulation (tDCS) and Its Therapeutic Effects in Chikungunya Fever
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chikungunya Fever
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2016-12-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: One of the major challenges faced by researchers working in the field of rehabilitation science is the ability to provide integrative approaches to the use of clinical practice. In this context it becomes increasingly necessary to construct investigative approaches, so that they can reach clinical practice in a shorter period of time,since the large volume of information produced globally does not impact in the short or medium term on new therapeutic recommendations. Among the various chronic painful entities, there is chikungunya fever as a highlight for having a rich clinical chronology in relation to pain. Its therapy is used done by drugs in almost all national and international consensuses, therefore therapy against pain in chikungunya fever is limited during the rehabilitation process. It is very important that the science of rehabilitation enhances methods of noninvasive brain modulation that enable, through the excitation or inhibition of specific cortical areas to produce pain inhibiting effects, providing a simple and low cost treatment to the clinical routine.Technological advances and non-invasive techniques to modulate brain function have been developed, for instance, Transcranial Direct Current Stimulation (tDCS).

The objective of the present project is to present the tDCS as a new modality of physical rehabilitation for the patient with chronic pain resulting from chikungunya fever. The purpose of the study is to present physical, behavioral and social results of the application of tDCS in chikungunya fever, suggesting an improvement in the quality of life and functional status of the individual.


Eligibility criteria: Inclusion Criteria:

* Laboratory or medical diagnosis of chikungunya fever, being in the chronic phase of the disease, intellectual and physical capacity preserved for conducting research tests.

Exclusion Criteria:

* History of seizures or epileptic disease, pregnancy, states associated with other previously diagnosed rheumatic diseases such as rheumatoid arthritis, gout and lupus, under 18 years and over 65 of age, patients with signs of severity and/or indication for hospitalization.

Primary outcomes:
measure: Change from baseline Pain at 3 weeks
timeFrame: Every day during 3 weeks (before treatment, during treatment and one week after treatment).
measure: Change from baseline Pain at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
measure: Change from baseline Pain at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
measure: Change from baseline Pain at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
measure: Change from baseline Pain at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
Secondary outcomes:
measure: Change from baseline Quality of Life at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
measure: Change from baseline Flexibility at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
measure: Change from baseline Flexibility at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
measure: Change from baseline Strength at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
measure: Change from baseline Strength at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
measure: Change from baseline Strength at 3 weeks
timeFrame: baseline (one week before starting stimulation), one week after baseline (after first stimulation), eleven days after baseline (after last stimulation) and 3 weeks after baseline.
Other outcomes:
Locations:
city: Santa cruz
country: Brazil
facility: Federal University of Rio Grande do Norte
state: Rio Grande do Norte
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: Rodrigo Pegado Freitas, PhD
role: STUDY_DIRECTOR
affiliation: Universidade Federal do Rio Grande do Norte
name: Edson Meneses Filho, Graduate
role: PRINCIPAL_INVESTIGATOR
References: