Healthy IndividualsNCT01872117
Assessment of Temperature by Infrared Thermography and Blood Conduction Velocity by Doppler After Applying Shortwave Diathermy and Microwave - Correlations With Cardiovascular and Hemodynamic Parameters
A study testing Shortwave therapy and Microwave therapy in people with Healthy Individuals, run by University of Sao Paulo at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals
- What is being tested?
- Shortwave therapy and Microwave therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Individuals who are using antipyretic medications
- With a history of pain, injury or surgery on joints studied
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Individuals
- Being tested
- Shortwave therapy, Microwave therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shortwave therapyOther
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 therapyOther
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 group | Role | What they receive |
|---|---|---|
| Applications of shortwave diathermy | Experimental | Not described Receives: Other: Shortwave therapy |
| Applications of microwave diathermy | Experimental | Not described Receives: Other: Microwave therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionSep 2014
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy IndividualsStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872117
- Sponsor's protocol ID
- U1111-1143-3596
- Status last verified
- Jul 2017
- First submitted
- 27 May 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01872117
- Acronym / sponsor ID
- U1111-1143-3596
- Conditions
- Healthy Individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2013 (actual)
- Primary completion
- Sep 2014 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Applications of shortwave diathermy | Experimental | Other: Shortwave therapy |
| Applications of microwave diathermy | Experimental | Other: Microwave therapy |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Individuals who are using antipyretic medications
- With a history of pain, injury or surgery on joints studied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Shortwave therapyWill 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 | Applications of shortwave diathermy |
| Microwave therapyWill 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. | Other | Applications of microwave diathermy |
Primary outcome
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.
1 secondary outcome
Change in conduction velocity blood
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shortwave therapy and Microwave therapy in people with Healthy Individuals, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous temperature changes after short wave diathermy and microwave (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.