Chikungunya fever
Conditions
Interventions
The participants will be randomized into two groups: a sham group and an active group. Randomization will be carried out based on the order of entry into the study, with their names randomized using a
E02.331.750
Sponsors
Universidade Federal do Rio Grande do Norte
Universidade Federal do Rio Grande do Norte
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Man or woman aged 18 to 65 years; be in chronic phase of chikungunya fever (least 3 month of the initial infection) and show laboratory tests or clinical diagnostic confirmation of chikungunya virus; pain related with more than 4 in a numeric rating scale; to have physical capacity to do physical evaluation and be capable of consenting to treatment and understanding study explanations and questionnaires; having provided informed consent
Exclusion criteria
Exclusion criteria: Electrical implants in the body; a history of epilepsy; people who are clinically contraindicated to receive tDCS such as having metal embedded in their scalp or brain; psychiatric illness, and history of drug abuse; pregnant women; signs of severity and/or indication of hospitalization; presence of previous rheumatic disease including gout, rheumatoid arthritis, fibromyalgia, lupus and others chronic pain syndromes with diagnosis prior to chikungunya
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected Outcome 1:To assess whether there is an improvement in pain among patients in the active group who received a 10-day treatment with active electrical stimulation. This will be verified using the visual analog pain scale evaluation method, where an improvement of 3 points is expected for clinically perceptible outcomes;Outcome Found 1: The study participants exhibited a moderate level of pain at baseline (the mean (SD) for active group: 51.26 (25.37); and sham group: 54.13 (25.84)). It is likely that due to this initial pain level, demonstrating a substantial difference post-treatment would be quite challenging. When comparing the baseline to the second follow-up, the active group exhibited a 26.4-point difference on the VAS scale, representing a 51% improvement (p = 0.03). A significant improvement in pain was observed in the active group according to the ANOVA test (p=0.03) | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected Outcome 2: To evaluate whether there is an improvement in functional capacity among patients in the active group who received a 10-day treatment with active electrical stimulation. This will be assessed using the health status access scale, where an improvement of 30% is expected;Outcome Found 2: A trend of improvement in functional capacity was observed in the Active group, as determined by the ANOVA (p = 0.06). The Active group showed a 42% improvement according to the health access questionnaire;Expected Outcome 3: To assess whether there is an improvement in the quality of life among patients in the active group who received a 10-day treatment with active electrical stimulation. This will be verified using the SF-36 quality of life scale, where an improvement of 30% is expected;Outcome Found 3: No significant difference was found between the groups according to the ANOVA test. Both the active and sham groups improved by 20% according to the SF-36 questionnaire. The sham group also showed improvement;Expected Outcome 4: To assess whether there is an improvement in pain catastrophizing among patients in the active group who received a 10-day treatment with active electrical stimulation. This will be evaluated using the Pain Catastrophizing Scale, with an expected improvement of 30%;Outcome Found 4: No significant difference was found between the groups according to the ANOVA test. The active group improved by 10%, while the sham group improved by 13% according to the catastrophization questionnaire;Expected Outcome 5: To assess whether there is an improvement in anxiety among patients in the active group who received a 10-day treatment with active electrical stimulation. This will be evaluated using the Hamilton Anxiety Scale, with an expected improvement of 30%;Outcome Found 5: No significant difference was found between the groups according to the ANOVA test. The active group improved by 56%, while the sham group improved by 60% according to the Hamilto | — |
Countries
Brazil
Contacts
Public ContactRodrigo Pegado de Freitas
Universidade Federal do Rio Grande do Norte
Outcome results
None listed