Effect of cranial magnetic stimulation on pain and mobility of people infected with human T-cell limphotropic virus type 1: randomized clinical trial
Not Applicable
- Conditions
- HTLV-I InfectionsC01.925.782.815.200.470
- Registration Number
- RBR-4zdtk9n
- Lead Sponsor
- Escola Bahiana de Medicina e Saúde Pública
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>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 Outcome Measures
Name Time Method The secondary outcome is the impact on the protocol's quality of life and the presence or absence of adverse effects.<br>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.<br>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.<br>The World Health Organization Quality of Life – WHOQOL-bref