- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872117
Assessment of Temperature by Infrared Thermography and Blood Conduction Velocity by Doppler After Applying Shortwave Diathermy and Microwave - Correlations With Cardiovascular and Hemodynamic Parameters
July 19, 2017 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sao Paulo
-
Ribeirao Preto, Sao Paulo, Brazil, 14049-900
- University of Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Applications of shortwave diathermy
|
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.
|
|
Experimental: Applications of microwave diathermy
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2013
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
May 27, 2013
First Submitted That Met QC Criteria
June 4, 2013
First Posted (Estimate)
June 7, 2013
Study Record Updates
Last Update Posted (Actual)
July 21, 2017
Last Update Submitted That Met QC Criteria
July 19, 2017
Last Verified
July 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1143-3596
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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