Trial Outcomes & Findings for Analysis of Human Tissue Temperature After Application of Therapeutic Modalities. (NCT NCT03601715)
NCT ID: NCT03601715
Last Updated: 2020-05-12
Results Overview
Evaluation of the most effective electrode arrangement (coplanar, contraplanar or longitudinal) in relation to temperature increase and heat conservation. Measured using a infrared camera in three sessions, with a washout period of at least 24 hours.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
3 days
Results posted on
2020-05-12
Participant Flow
Paticipants, reached through social media, volunteered to participate in the study.Participant enrollment began on 9/3/18 and the last participant was enrolled on 11/9/18.
All the twenty health enrolled male subjects met the inclusion criteria and were randomly allocated an order in which treatments were received.
Participant milestones
| Measure |
Coplanar First, Then Contraplanar and at Last Longitudinal
After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Coplanar arrangement application, then, after a washout period of at least one day received Contraplanar application and after a washout period of at least one day received Longitudinal application.
|
Contraplanar First, Then Coplanar and at Last Longitudinal
After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Contraplanar arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Longitudinal application.
|
Longitudinal First, Then Coplanar and at Last Contraplanar
After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Longitudinal arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Contraplanar application.
|
|---|---|---|---|
|
First Intervention
STARTED
|
7
|
7
|
6
|
|
First Intervention
COMPLETED
|
7
|
7
|
6
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
|
Washout 1 (at Least 24 Hours)
STARTED
|
7
|
7
|
6
|
|
Washout 1 (at Least 24 Hours)
COMPLETED
|
7
|
7
|
6
|
|
Washout 1 (at Least 24 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention
STARTED
|
7
|
7
|
6
|
|
Second Intervention
COMPLETED
|
6
|
6
|
6
|
|
Second Intervention
NOT COMPLETED
|
1
|
1
|
0
|
|
Wash Out 2 (at Least 24 Hours)
STARTED
|
6
|
6
|
6
|
|
Wash Out 2 (at Least 24 Hours)
COMPLETED
|
6
|
6
|
6
|
|
Wash Out 2 (at Least 24 Hours)
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention
STARTED
|
6
|
6
|
6
|
|
Third Intervention
COMPLETED
|
6
|
6
|
6
|
|
Third Intervention
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Coplanar First, Then Contraplanar and at Last Longitudinal
After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Coplanar arrangement application, then, after a washout period of at least one day received Contraplanar application and after a washout period of at least one day received Longitudinal application.
|
Contraplanar First, Then Coplanar and at Last Longitudinal
After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Contraplanar arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Longitudinal application.
|
Longitudinal First, Then Coplanar and at Last Contraplanar
After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Longitudinal arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Contraplanar application.
|
|---|---|---|---|
|
Second Intervention
Lost to Follow-up
|
1
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Coplanar First, Then Contraplanar and at Last Longitudinal
n=7 Participants
After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Coplanar arrangement application, then, after a washout period of at least one day received Contraplanar application and after a washout period of at least one day received Longitudinal application.
|
Contraplanar First, Then Coplanar and at Last Longitudinal
n=7 Participants
After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Contraplanar arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Longitudinal application.
|
Longitudinal First, Then Coplanar and at Last Contraplanar
n=6 Participants
After 20 minutes of acclimatization, participants received the capacitive arrangement as determined for 20 minutes. First, received Longitudinal arrangement application, then, after a washout period of at least one day received Coplanar application and after a washout period of at least one day received Contraplanar application.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
21.7 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
22.2 years
STANDARD_DEVIATION 1.79 • n=7 Participants
|
20 years
STANDARD_DEVIATION 2.09 • n=6 Participants
|
21.4 years
STANDARD_DEVIATION 2.09 • n=20 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=7 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=7 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=6 Participants
|
20 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Brazil
|
7 participants
n=7 Participants
|
7 participants
n=7 Participants
|
6 participants
n=6 Participants
|
20 participants
n=20 Participants
|
|
Height
|
1.74 meters
STANDARD_DEVIATION 0.08 • n=7 Participants
|
1.75 meters
STANDARD_DEVIATION 0.04 • n=7 Participants
|
1.78 meters
STANDARD_DEVIATION 0.08 • n=6 Participants
|
1.76 meters
STANDARD_DEVIATION 0.07 • n=20 Participants
|
|
Mass
|
74 Kilograms
STANDARD_DEVIATION 12.02 • n=7 Participants
|
73 Kilograms
STANDARD_DEVIATION 14.4 • n=7 Participants
|
72.6 Kilograms
STANDARD_DEVIATION 6.63 • n=6 Participants
|
73.2 Kilograms
STANDARD_DEVIATION 10.6 • n=20 Participants
|
|
Body mass index
|
24.2 Kilograms/meters²
STANDARD_DEVIATION 3.09 • n=7 Participants
|
23.4 Kilograms/meters²
STANDARD_DEVIATION 3.37 • n=7 Participants
|
22.9 Kilograms/meters²
STANDARD_DEVIATION 2.2 • n=6 Participants
|
23.6 Kilograms/meters²
STANDARD_DEVIATION 2.46 • n=20 Participants
|
PRIMARY outcome
Timeframe: 3 daysPopulation: Occurred 2 losses to follow up.
Evaluation of the most effective electrode arrangement (coplanar, contraplanar or longitudinal) in relation to temperature increase and heat conservation. Measured using a infrared camera in three sessions, with a washout period of at least 24 hours.
Outcome measures
| Measure |
Coplanar
n=18 Participants
Electrode placed as far apart as the cross-sectional diameter of the pad electrode on the same aspect of the right tight.
After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject.
|
Contraplanar
n=18 Participants
Electrode placed over opposite aspects in the right tight centre.
After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject.
|
Longitudinal
n=18 Participants
Each electrode is placed at the final portion of the limb in opposite aspects of the right tight.
After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject.
|
|---|---|---|---|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Thigh centre (after electrodes removal)
|
1.72 Celsius
Standard Deviation 1.01
|
0.58 Celsius
Standard Deviation 0.99
|
0.94 Celsius
Standard Deviation 0.51
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Under the electrode (after electrodes removal)
|
7.9 Celsius
Standard Deviation 1.76
|
6.52 Celsius
Standard Deviation 2.68
|
7.46 Celsius
Standard Deviation 1.8
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Thigh centre (5 min after removal)
|
1.33 Celsius
Standard Deviation 0.9
|
0.12 Celsius
Standard Deviation 0.9
|
0.61 Celsius
Standard Deviation 0.44
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Under the electrode (5 min after removal)
|
2.76 Celsius
Standard Deviation 1.17
|
2.35 Celsius
Standard Deviation 1.53
|
2.65 Celsius
Standard Deviation 1.3
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Thigh centre (10 min after removal)
|
1.17 Celsius
Standard Deviation 1.01
|
-0.06 Celsius
Standard Deviation 0.98
|
0.45 Celsius
Standard Deviation 0.55
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Under the electrode (10 min after removal)
|
2.15 Celsius
Standard Deviation 1.21
|
1.87 Celsius
Standard Deviation 1.36
|
2.06 Celsius
Standard Deviation 1.1
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Thigh centre (15 min after removal)
|
1.07 Celsius
Standard Deviation 1.06
|
-0.17 Celsius
Standard Deviation 1.02
|
0.32 Celsius
Standard Deviation 0.69
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Under the electrode (15 min after removal)
|
1.8 Celsius
Standard Deviation 1.22
|
1.48 Celsius
Standard Deviation 1.29
|
1.74 Celsius
Standard Deviation 1.07
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Thigh centre (20 min after removal)
|
0.83 Celsius
Standard Deviation 1.19
|
-0.07 Celsius
Standard Deviation 1.06
|
0.22 Celsius
Standard Deviation 0.78
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Under the electrode (20 min after removal)
|
1.41 Celsius
Standard Deviation 1.27
|
1.28 Celsius
Standard Deviation 1.28
|
1.43 Celsius
Standard Deviation 1.07
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Thigh centre (25 min after removal)
|
0.78 Celsius
Standard Deviation 1.17
|
-0.09 Celsius
Standard Deviation 1.09
|
0.16 Celsius
Standard Deviation 0.73
|
|
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Under the electrode (25 min after removal)
|
1.14 Celsius
Standard Deviation 1.22
|
1.1 Celsius
Standard Deviation 1.16
|
0.94 Celsius
Standard Deviation 1.29
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Occurred 2 losses to follow up.
Determine which capacitance shortwave technique will increase the temperature the most after 20 minutes of application. The skin temperature will be verified by infrared thermography. This evaluation will occur in three 24 hours apart visits, each for one of the three capacitance shortwave technique.
Outcome measures
| Measure |
Coplanar
n=18 Participants
Electrode placed as far apart as the cross-sectional diameter of the pad electrode on the same aspect of the right tight.
After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject.
|
Contraplanar
n=18 Participants
Electrode placed over opposite aspects in the right tight centre.
After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject.
|
Longitudinal
n=18 Participants
Each electrode is placed at the final portion of the limb in opposite aspects of the right tight.
After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject.
|
|---|---|---|---|
|
Temperature Increase
On thigh centre, after electrodes removal
|
1.72 Celsius
Standard Deviation 1.01
|
0.58 Celsius
Standard Deviation 0.99
|
0.94 Celsius
Standard Deviation 0.51
|
|
Temperature Increase
Under the electrode (after electrodes removal)
|
7.9 Celsius
Standard Deviation 1.76
|
6.52 Celsius
Standard Deviation 2.68
|
7.46 Celsius
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 3 daysPopulation: Occurred 2 losses to follow up.
Determinate which capacitance shortwave technique retain the induced heat for longer time. The skin temperature will be verified by infrared thermography before the application and after during 25 minutes, 1 minutes apart each measure. This evaluation will occur in three 24 hours apart visits, each for one of the three capacitance shortwave technique.
Outcome measures
| Measure |
Coplanar
n=18 Participants
Electrode placed as far apart as the cross-sectional diameter of the pad electrode on the same aspect of the right tight.
After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject.
|
Contraplanar
n=18 Participants
Electrode placed over opposite aspects in the right tight centre.
After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject.
|
Longitudinal
n=18 Participants
Each electrode is placed at the final portion of the limb in opposite aspects of the right tight.
After 20 minutes of acclimatization, participants received application for 20 minutes. The electrode pads were surrounded by felt and positioned over 1 cm of toweling, besides, we wrapped the tight and the electrodes using an elastic band. We controlled the intensity based on a referred warm heat perception by the subject.
|
|---|---|---|---|
|
Heat Conservation
Under the electrode (25 min after removal)
|
1.14 Celsius
Standard Deviation 1.22
|
1.1 Celsius
Standard Deviation 1.16
|
0.94 Celsius
Standard Deviation 1.29
|
|
Heat Conservation
Thigh centre (5 min after removal)
|
1.33 Celsius
Standard Deviation 0.9
|
0.12 Celsius
Standard Deviation 0.9
|
0.61 Celsius
Standard Deviation 0.44
|
|
Heat Conservation
Under the electrode (5 min after removal)
|
2.76 Celsius
Standard Deviation 1.17
|
2.35 Celsius
Standard Deviation 1.53
|
2.65 Celsius
Standard Deviation 1.3
|
|
Heat Conservation
Thigh centre (10 min after removal)
|
1.17 Celsius
Standard Deviation 1.01
|
-0.06 Celsius
Standard Deviation 0.98
|
0.45 Celsius
Standard Deviation 0.55
|
|
Heat Conservation
Under the electrode (10 min after removal)
|
2.15 Celsius
Standard Deviation 1.21
|
1.87 Celsius
Standard Deviation 1.36
|
2.06 Celsius
Standard Deviation 1.1
|
|
Heat Conservation
Thigh centre (15 min after removal)
|
1.07 Celsius
Standard Deviation 1.06
|
-0.17 Celsius
Standard Deviation 1.02
|
0.32 Celsius
Standard Deviation 0.69
|
|
Heat Conservation
Under the electrode (15 min after removal)
|
1.8 Celsius
Standard Deviation 1.22
|
1.48 Celsius
Standard Deviation 1.29
|
1.74 Celsius
Standard Deviation 1.07
|
|
Heat Conservation
Thigh centre (20 min after removal)
|
0.83 Celsius
Standard Deviation 1.19
|
-0.07 Celsius
Standard Deviation 1.06
|
0.22 Celsius
Standard Deviation 0.78
|
|
Heat Conservation
Under the electrode (20 min after removal)
|
1.41 Celsius
Standard Deviation 1.27
|
1.28 Celsius
Standard Deviation 1.28
|
1.43 Celsius
Standard Deviation 1.07
|
|
Heat Conservation
Thigh centre (25 min after removal)
|
0.78 Celsius
Standard Deviation 1.17
|
-0.09 Celsius
Standard Deviation 1.09
|
0.16 Celsius
Standard Deviation 0.73
|
Adverse Events
Coplanar
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Contraplanar
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Longitudinal
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Inaihá Benincá
Federal University of Santa Catarina
Phone: (+55 48) 3721-6255
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place