Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
24 participants
INTERVENTIONAL
2013-01-31
2013-01-31
Brief Summary
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Detailed Description
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The study included 24 subjects randomly recruited from both sexes and from four different ethnic groups: white, brown, black and asian with different ages, individuals intolerant to cold, suffering any change in skin sensitivity, illness from infectious diseases or previously diagnosed to respond negatively to the use of cold were excluded.
The survey was conducted in the clinic Physiotherapy Universidade Paulista - UNIP in light and airy ambience, with recording of the mean daily temperature in degrees Celsius planned for the capital of São Paulo by newsletter Climatempo available and accessed http://www.climatempo.com.br/previsao-do-tempo/cidade/ Before all applications, the average temperature obtained in the days from the application was 21.93° Celsius.
For obtaining of personal data and anthropometric evaluations, a data sheet prepared by the authors to self-fulfillment, and then calculated the BMI of subjects, if in doubt, check the height and body mass was performed before the application of cryotherapy. Participants were divided into 4 groups of different ethnicities - white, brown, black and asian; ethnicity was proven through the birth certificates of volunteers, according to the classification described by the Brazilian Institute of Geography and Statistics - IBGE.
All participants were maintained in supine position for 20 minutes to rest and stabilization of body temperature, sleep after receiving an application through the cold thermal bag Thermo Gel ® brand size "P" consisting of a cellulose-based gel for subsequently receiving of cryotherapy in the middle third of the right thigh and left earlier, leaving 15-20 cm from the anterior superior iliac spine - ASIS side tested, depending on the stature of the individual being assessed and 5 cm away from the surface to be evaluated, according to manufacturer's instructions. The temperature was verified on site described before, during and after applications of cryotherapy which lasted for 30 minutes and then recorded. To check the temperature after application of cryotherapy was used a thermometer brand CASON ® INFRARED THERMOMETER AC 380 (- 32 º C 380 º C).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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white
cryotherapy application
cryotherapy application
* Height, weight and BMI verification
* subjects in supine position after 20 minutes of resting
* cryotherapy application by cold thermal bag (thermoGel brand) size P
* 15-20 cm above the ASIS
* temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil
black
cryotherapy application
cryotherapy application
* Height, weight and BMI verification
* subjects in supine position after 20 minutes of resting
* cryotherapy application by cold thermal bag (thermoGel brand) size P
* 15-20 cm above the ASIS
* temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil
Brown
cryotherapy application
cryotherapy application
* Height, weight and BMI verification
* subjects in supine position after 20 minutes of resting
* cryotherapy application by cold thermal bag (thermoGel brand) size P
* 15-20 cm above the ASIS
* temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil
asian
cryotherapy application
cryotherapy application
* Height, weight and BMI verification
* subjects in supine position after 20 minutes of resting
* cryotherapy application by cold thermal bag (thermoGel brand) size P
* 15-20 cm above the ASIS
* temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil
Interventions
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cryotherapy application
* Height, weight and BMI verification
* subjects in supine position after 20 minutes of resting
* cryotherapy application by cold thermal bag (thermoGel brand) size P
* 15-20 cm above the ASIS
* temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
79 Years
ALL
Yes
Sponsors
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Paulista University
OTHER
Responsible Party
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Mauricio Correa Lima
expert
Principal Investigators
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Mauricio C Lima, expert
Role: PRINCIPAL_INVESTIGATOR
Paulista University
Locations
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Rehabilitation Center of Universidade Paulista
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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125.608
Identifier Type: -
Identifier Source: org_study_id