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Assessment of Temperature by Infrared Thermography and Blood Conduction Velocity by Doppler After Applying Shortwave Diathermy and Microwave - Correlations With Cardiovascular and Hemodynamic Parameters

Primary Purpose

Healthy Individuals

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Shortwave therapy
Microwave therapy
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Individuals

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Age group aged between 18 and 30 years
  • No previous disease-order circulatory or nervous and did not have metal implants in areas to be studied,
  • Are not menstruating or even a week before, due to the change of blood flow in these periods

Exclusion Criteria:

  • Individuals who are using antipyretic medications
  • With a history of pain, injury or surgery on joints studied

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Applications of shortwave diathermy

Applications of microwave diathermy

Arm Description

Outcomes

Primary Outcome Measures

Cutaneous temperature changes after short wave diathermy and microwave
The skin temperature data will be acquired by a digital infrared thermographer at a distance of 1,5 m litter. 3 thermographic images will be collected over the application of diathermy at times 0, 10 and 20 min. For this, after the initial 10 min, the electrodes will be quickly removed from contact with the skin surface, so it can also be observed at room temperature under the electrode. Completed the 20 min of application will be also evaluated the temperature effect on residual time 10 and 20 min after application, where the individual remained at rest in the same position.

Secondary Outcome Measures

Change in conduction velocity blood
Data from the femoral artery blood flow will be collected through the Doppler Portable Ultrasound wave continues. Data will be collected after 20 minutes of acclimatization, immediately after application of shortwave diathermy and immediately after the 20 minutes of time resudual application.

Full Information

First Posted
May 27, 2013
Last Updated
July 19, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01872117
Brief Title
Assessment of Temperature by Infrared Thermography and Blood Conduction Velocity by Doppler After Applying Shortwave Diathermy and Microwave - Correlations With Cardiovascular and Hemodynamic Parameters
Official Title
Assessment of Temperature by Infrared Thermography and Blood Conduction Velocity by Doppler After Applying Shortwave Diathermy and Microwave - Correlations With Cardiovascular and Hemodynamic Parameters
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (Actual)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The deep heat therapies are increasingly frequent in daily physical therapist for the treatment of musculoskeletal diseases. The use of such procedures is justified by their analgesic, anti-inflammatory, antiespasmolíticos and hiperemiantes. However, studies on the cardiovascular effects of these therapies are still incipient. Therefore, this study has as objectives: map the skin temperature changes in the lower limbs in different areas and positions after applying shortwave diathermy and microwave; assess hemodynamic and autonomic cardiovascular parameters, and investigate the occurrence of changes in conduction velocity superficial blood resulting from the application of these thermal features. The study will be conducted on 40 female volunteers between 18 and 30 years, university, healthy, that fit the inclusion and exclusion criteria of the study. The analysis by infrared thermography will be held in a room with temperature maintained at 23 ± 1°C and humidity average 50%. The volunteers will stay in prone position, with the legs bare, resting for 20 min to stabilize skin temperature with temperature of the room. After this period will be held applying diathermy of shortwave or microwave for 20 minutes at moderate heat on the lower limb regions of the hamstrings and triceps surae in extension and flexion to 180° to 90°. The records beat to beat blood pressure and heart rate to autonomic and cardiovascular hemodynamic evaluation will be performed by means of equipment Finometer (Finapress Medical Systems, Inc.) and electrocardiogram (ADInstruments, Inc.), respectively, before and after application of diathermy. On the other hand, the images will be processed using FLIR ThermoScan and blood flow data will be collected through the Doppler ultrasound. The results will be processed and analyzed using descriptive statistics, submitted to a linear regression model with mixed effects (random effects and fixed), with p≤0.05.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Individuals

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Applications of shortwave diathermy
Arm Type
Experimental
Arm Title
Applications of microwave diathermy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Shortwave therapy
Intervention Description
Will be conducted in four stages, on different days: i) lower limb in extension and application of 180° for 20 min, ii) Lower limb knee flexion of 90° and application for 20 min; iii) lower limb extension in 180° without application iv) lower limb knee flexion of 90° without application.
Intervention Type
Other
Intervention Name(s)
Microwave therapy
Intervention Description
Will be held in two stages, on different days: i) lower limb in extension with angle of 180° and application for 20 min, ii) lower limb in extension of 180° without application.
Primary Outcome Measure Information:
Title
Cutaneous temperature changes after short wave diathermy and microwave
Description
The skin temperature data will be acquired by a digital infrared thermographer at a distance of 1,5 m litter. 3 thermographic images will be collected over the application of diathermy at times 0, 10 and 20 min. For this, after the initial 10 min, the electrodes will be quickly removed from contact with the skin surface, so it can also be observed at room temperature under the electrode. Completed the 20 min of application will be also evaluated the temperature effect on residual time 10 and 20 min after application, where the individual remained at rest in the same position.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in conduction velocity blood
Description
Data from the femoral artery blood flow will be collected through the Doppler Portable Ultrasound wave continues. Data will be collected after 20 minutes of acclimatization, immediately after application of shortwave diathermy and immediately after the 20 minutes of time resudual application.
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age group aged between 18 and 30 years No previous disease-order circulatory or nervous and did not have metal implants in areas to be studied, Are not menstruating or even a week before, due to the change of blood flow in these periods Exclusion Criteria: Individuals who are using antipyretic medications With a history of pain, injury or surgery on joints studied
Facility Information:
Facility Name
University of Sao Paulo
City
Ribeirao Preto
State/Province
Sao Paulo
ZIP/Postal Code
14049-900
Country
Brazil

12. IPD Sharing Statement

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Assessment of Temperature by Infrared Thermography and Blood Conduction Velocity by Doppler After Applying Shortwave Diathermy and Microwave - Correlations With Cardiovascular and Hemodynamic Parameters

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