HTLV-I Infections
Conditions
Interventions
STUDY DESIGN: Randomized clinical trial.
POPULATION: HTLV-infected individuals diagnosed according to the World Health Organization (WHO) criteria, classified as symptomatic, defined or probable for H
2º. Potential participants will be invited to present the project and apply the anamnestic questionnaire to complement the eligibility criteria
3º. Those who meet the eligibility criteria will be asked about their interest in participating in the research after presenting the objectives and procedures to which they will be submitted. Patients
4º. Participants will be randomized by a member of the team without contact with the evaluators and with the patients, according to the number from 1 to 40, with the help of the online tool www.random
C01.925.782.815.200.470
Sponsors
Escola Bahiana de Medicina e Saúde Pública
Faculdade de Medicina da Universidade Federal da Bahia
Eligibility
Age
21 Years to No maximum
Inclusion criteria
Inclusion criteria: To be included in the protocol, the participant must have: age> 20 years; be a carrier of HTLV-1; be a community walker with or without orthosis; with chronic pain (= 6 months) in the lower back and / or lower limbs and ability to sign the written consent form
Exclusion criteria
Exclusion criteria: Participants should be excluded if they have: history of epilepsy, cancer, are pregnant women; have a cardiac pacemaker and / or metallic implant in the brain or skull; if they have used illicit drugs and / or alcohol in the last six months; if they use controlled medications; and if they are being accompanied in an exercise program in the 30 days prior to the intervention by rTMS.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is pain intensity. The instrument used to assess pain intensity is the Visual Analog Scale of Pain(VAS-P). The lower the value of the visual analogue pain scale will imply a good result of the treatment with neuromodulation.;Another primary outcome is functional independence, which is measured using the TUG (Timed Up and Go test), which is a test of time to get up and walk, which assesses mobility and balance. The shorter the time taken to perform the test, the greater the mobility and functional independence. The longer the time, the greater the dependency and the greater the risk of falling. With the treatment through neuromodulation, it is believed that there is a decrease in TUG time, which will lead to an improvement in functional independence. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome is the impact on the protocol's quality of life and the presence or absence of adverse effects. Quality of life is measured using the WHOQOL-bref questionnaire, which is an instrument of the World Health Organization to assess quality of life. The higher the sum total for the domains: physical, psychological, social relationships and environment, the better the treatment response. In addition, through this assessment it will also be possible to identify the presence or absence of any adverse effects with the treatment. It is believed that with neuromodulation there may be an improvement in the quality of life of the participants, mainly due to the improvement in pain and functional independence, as it tends to imply an improvement in the domains assessed by this instrument. The World Health Organization Quality of Life – WHOQOL-bref | — |
Countries
Brazil
Contacts
Public ContactKÁTIA SÁ
Outcome results
None listed