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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01872117
Other study ID # U1111-1143-3596
Secondary ID
Status Completed
Phase N/A
First received May 27, 2013
Last updated July 19, 2017
Start date May 2013
Est. completion date May 2015

Study information

Verified date July 2017
Source University of Sao Paulo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date May 2015
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Brazil University of Sao Paulo Ribeirao Preto Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 2 years
Secondary 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. 2 years
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