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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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ClinicalTrials.gov Identifier: NCT01872117
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Rinaldo Roberto de Jesus Guirro, University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE May 27, 2013
First Posted Date  ICMJE June 7, 2013
Last Update Posted Date July 21, 2017
Actual Study Start Date  ICMJE May 2013
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
Cutaneous temperature changes after short wave diathermy and microwave [ Time Frame: 2 years ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01872117 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2013)
Change in conduction velocity blood [ Time Frame: 2 years ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE Assessment of Temperature by Infrared Thermography and Blood Conduction Velocity by Doppler After Applying Shortwave Diathermy and Microwave - Correlations With Cardiovascular and Hemodynamic Parameters
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE Healthy Individuals
Intervention  ICMJE
  • Other: Shortwave therapy
    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.
  • Other: Microwave therapy
    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.
Study Arms  ICMJE
  • Experimental: Applications of shortwave diathermy
    Intervention: Other: Shortwave therapy
  • Experimental: Applications of microwave diathermy
    Intervention: Other: Microwave therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 4, 2013)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date September 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 30 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01872117
Other Study ID Numbers  ICMJE U1111-1143-3596
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Sao Paulo
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP