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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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REBEC |
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Last refreshed on:
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29 April 2013 |
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Main ID: |
RBR-5hkrss |
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Date of registration:
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01/02/2012 |
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Primary sponsor: |
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Public title:
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Effect of high-voltage electrical stimulation after carpal tunnel syndrome surgery
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Scientific title:
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Effects of high voltage eletrical stimulation on pain and disfunction in workers with carpal tunnel syndrome |
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Date of first enrolment:
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21/04/2011 |
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Target sample size:
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14 |
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Recruitment status: |
recruitment completed |
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URL:
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http://www.ensaiosclinicos.gov.br/rg/RBR-5hkrss/ |
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Study type:
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Study design:
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Therapeutic,double-blind, two arms, parallel, randomized clinical trial.
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Rosana
Teodori |
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Address:
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Rodovia do Açucar, km 156
13.400-911
Piracicaba
Brazil |
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Telephone:
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(19) 31241515 |
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Email:
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rteodori@unimep.br |
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Affiliation:
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Faculdade de Ciências da Saúde - UNIMEP |
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Name:
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Cesar
Denari |
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Address:
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Rua Episcopal, nº 1700, apt 31
13560-570
São Carlos
Brazil |
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Telephone:
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(19)82943988 |
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Email:
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cesardenari@yahoo.com.br |
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Affiliation:
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Faculdade de Ciências da Saúde - UNIMEP |
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Key inclusion & exclusion criteria
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Inclusion criteria: Female patients, aged between 20 and 60 years, after surgery for carpal tunnel decompression
Exclusion criteria: Be doing physical therapy at another location;
miss two or more intervention sessions, without replacement of the lost session.
Age minimum:
20Y
Age maximum:
60Y
Gender:
F
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Health Condition(s) or Problem(s) studied
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Carpal tunnel syndrome, occupational sick leave
C10.668.829.500.500.200
SP4.046.457
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Intervention(s)
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The patients will be divided into two groups: High voltagem electrical stimulation (HVES)(HVES + kinesiotherapy, n=9) and placebo - PL (device off HVES + kinesiotherapy, n=5). The parameters for the application of HVES are: frequency 10 hz, pulse width determined by the device with two twin pulses of 20 ms each, with an interval of 100 µs between them, voltage of 100 Volts, reaching the threshold submotor, negative polarity (HVES cathode) on both channels for 30 minutes, 3 times a week to complete 20 sessions. The kinesiotherapy includes active mobilization of the shoulder, elbow, wrist and fingers, muscle stretching, exercise, handling and resistance, and desensitization/sensitization of the involved areas.
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Primary Outcome(s)
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Reduction of pain after surgery for decompression of the median nerve in the carpal tunnel in humans by visual analogue scale. It is expected that the visual analogue scale present lower values in each session.
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Secondary Outcome(s)
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Reduction in the values of the Boston questionnaire and visual analog scale and the absence of nervous injury on physical examination.
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Secondary ID(s)
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0011/2011
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Source(s) of Monetary Support
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Faculdade de Ciências da Saúde - UNIMEP - Piracicaba, SP, Brazil
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