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Analysis of Human Tissue Temperature After Application of Therapeutic Modalities.

Coplanar Arrangement of Shortwave Diathermy is the Most Efficient in Skin Temperature Change: A Randomized Crossover Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03601715
Enrollment
20
Registered
2018-07-26
Start date
2018-09-03
Completion date
2018-12-10
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health, Humans, Young Adult

Keywords

Diathermy, Short-Wave Therapy, Body temperature, Skin Temperature

Brief summary

Attempting an effective treatment is essential to the physiotherapist to understand how his conducts affect body tissues and the whole system, besides understand properly how and when therapeutic modalities could be use in the rehabilitation process. There are several research articles pointing the use of heat as an efficient agent to accelerate tissue healing. Clarifying the remaining doubts related to therapeutic modalities use can be beneficial for functional rehabilitation. In physiotherapy, shortwave diathermy is one of the standards treatments for heat inducement. The capacitance shortwave technique consists in the use of two pad electrodes that can be positioned in three different arrangements: coplanar (placed side by side on the same aspect of the part to be treated), contraplanar (placed over opposite aspects of the body part to be treated) and longitudinal (one electrode is placed at each end of the limb in opposite aspects of the body par to be treated). There is no evidence of which arrangement is the most efficient. Besides shortwave diathermy being a very established therapeutic modality, the use of this recourse in the most effective way rely on the properly answer of the remaining questions related to its application. Therefore, the purpose of this study is to analyze which one of the capacitance shortwave technique is the most efficient in inducing and maintaining heat. Given the high-frequency waves field orientation could be suggested that the coplanar arrangement will lead to bigger heat inducement, and will maintain it for longer time.

Detailed description

The data for the sample size calculation was taken from a pilot study of 8 subjects. The software used to calculate the sample was GPower 3.1.9.2. A 18 subjects sample were obtained to reach a power of 90%, needed to detect a difference on the average of the groups in repeated measures with an alpha of 5%. The sample size was raised to 20 subjects for eventually lost. The subjects will be chosen through social media and informal invitations. The subjects will attend to the laboratory four times, the first day for orientation and measurements (body mass and skinfold), the data collection will start on the second day. The room temperature will be set between 23 °C and 25 °C, and the humidity around 70%. The subject will be placed in supine position on the stretcher, instructed to relax and not touch the right thigh region for 20 minutes before the intervention (for body temperature stabilization). The thigh size will be measured form the base of the patella to the anterior superior iliac spine and the center marked to determine the place where the temperature will be collected. The minimum space between electrodes position will be at least of the size of one electrode. The temperature of the right thigh will be measured by infrared thermography before the intervention, right after the removal and every minute until the total time of the intervention. To summarize the data, it will be used descriptive statistics, the values of average, standard deviation and the collected measurements will be identified. Through Shapiro-Wilk test the distribution of data regarding normality will be verified. To compare the initial and the final test values the ANOVA and the post-hoc of Bonferroni will be used. In the case of data being out of the normal standards, a transformation will be used to reach the normality. If the data still don't reach the normality after the transformation, the non-parametric tests will be used (Mann-Whitney e Kruskal Walis). The confidence level adopted for all tests will be 95% (p \<0.05).

Interventions

OTHERCoplanar

The coplanar arrangement will be applicated in each one of the subjects. The intervention will last 20 minutes. A towel will be placed between the pad electrode and the skin to improve contact, besides, the tight and the electrode will be wrapped with an elastic band for the same purpose. The subject will receive orientation related to the heat intensity, it must be a comfortable perception of heat (the intensity will be regulated on the equipment to guarantee that).

OTHERContraplanar

The contraplanar arrangement will be applicated in each one of the subjects. The intervention will last 20 minutes. A towel will be placed between the pad electrode and the skin to improve contact, besides, the tight and the electrode will be wrapped with an elastic band for the same purpose. The subject will receive orientation related to the heat intensity, it must be a comfortable perception of heat (the intensity will be regulated on the equipment to guarantee that).

The longitudinal arrangement will be applicated in each one of the subjects. The intervention will last 20 minutes. A towel will be placed between the pad electrode and the skin to improve contact, besides, the tight and the electrode will be wrapped with an elastic band for the same purpose. The subject will receive orientation related to the heat intensity, it must be a comfortable perception of heat (the intensity will be regulated on the equipment to guarantee that).

Sponsors

Santa Catarina Federal University
CollaboratorOTHER
Alessandro Haupenthal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)

Intervention model description

A randomized single blind, crossover experimental study.

Eligibility

Sex/Gender
MALE
Age
19 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* No orthopedic injury in three months prior to the study; * A minimum of 19 years of age, and a maximum of 40 years; * Male; * Must agree not to practice exercise the day before the study and not ingest caffeine, alcohol, or food one hour before intervention.

Exclusion criteria

* Skinfold minor than 2cm; * Circulatory system disease; * Ischemic tissue or malignant tumors; * External fixation, metal or pacemaker; * Any thigh open wound; * Muscular or neurological disease; * Diabetes diagnosed; * Cigarette smoker.

Design outcomes

Primary

MeasureTime frameDescription
The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography3 daysEvaluation 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.

Secondary

MeasureTime frameDescription
Temperature Increase3 daysDetermine 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.
Heat Conservation3 daysDeterminate 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.

Countries

Brazil

Participant flow

Recruitment details

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.

Pre-assignment details

All the twenty health enrolled male subjects met the inclusion criteria and were randomly allocated an order in which treatments were received.

Participants by arm

ArmCount
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.
7
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.
7
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.
6
Total20

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Second InterventionLost to Follow-up110

Baseline characteristics

CharacteristicCoplanar First, Then Contraplanar and at Last LongitudinalContraplanar First, Then Coplanar and at Last LongitudinalLongitudinal First, Then Coplanar and at Last ContraplanarTotal
Age, Continuous21.7 years
STANDARD_DEVIATION 1.6
22.2 years
STANDARD_DEVIATION 1.79
20 years
STANDARD_DEVIATION 2.09
21.4 years
STANDARD_DEVIATION 2.09
Body mass index24.2 Kilograms/meters²
STANDARD_DEVIATION 3.09
23.4 Kilograms/meters²
STANDARD_DEVIATION 3.37
22.9 Kilograms/meters²
STANDARD_DEVIATION 2.2
23.6 Kilograms/meters²
STANDARD_DEVIATION 2.46
Height1.74 meters
STANDARD_DEVIATION 0.08
1.75 meters
STANDARD_DEVIATION 0.04
1.78 meters
STANDARD_DEVIATION 0.08
1.76 meters
STANDARD_DEVIATION 0.07
Mass74 Kilograms
STANDARD_DEVIATION 12.02
73 Kilograms
STANDARD_DEVIATION 14.4
72.6 Kilograms
STANDARD_DEVIATION 6.63
73.2 Kilograms
STANDARD_DEVIATION 10.6
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
Brazil
7 participants7 participants6 participants20 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants0 Participants
Sex: Female, Male
Male
7 Participants7 Participants6 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 200 / 200 / 18
other
Total, other adverse events
0 / 200 / 200 / 18
serious
Total, serious adverse events
0 / 200 / 200 / 18

Outcome results

Primary

The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography

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.

Time frame: 3 days

Population: Occurred 2 losses to follow up.

ArmMeasureGroupValue (MEAN)Dispersion
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (15 min after removal)1.8 CelsiusStandard Deviation 1.22
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (5 min after removal)1.33 CelsiusStandard Deviation 0.9
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (25 min after removal)0.78 CelsiusStandard Deviation 1.17
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (after electrodes removal)1.72 CelsiusStandard Deviation 1.01
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (15 min after removal)1.07 CelsiusStandard Deviation 1.06
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (after electrodes removal)7.9 CelsiusStandard Deviation 1.76
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (25 min after removal)1.14 CelsiusStandard Deviation 1.22
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (10 min after removal)1.17 CelsiusStandard Deviation 1.01
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (20 min after removal)1.41 CelsiusStandard Deviation 1.27
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (20 min after removal)0.83 CelsiusStandard Deviation 1.19
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (10 min after removal)2.15 CelsiusStandard Deviation 1.21
CoplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (5 min after removal)2.76 CelsiusStandard Deviation 1.17
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (20 min after removal)1.28 CelsiusStandard Deviation 1.28
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (10 min after removal)1.87 CelsiusStandard Deviation 1.36
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (15 min after removal)1.48 CelsiusStandard Deviation 1.29
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (20 min after removal)-0.07 CelsiusStandard Deviation 1.06
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (25 min after removal)-0.09 CelsiusStandard Deviation 1.09
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (5 min after removal)2.35 CelsiusStandard Deviation 1.53
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (25 min after removal)1.1 CelsiusStandard Deviation 1.16
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (15 min after removal)-0.17 CelsiusStandard Deviation 1.02
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (after electrodes removal)0.58 CelsiusStandard Deviation 0.99
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (after electrodes removal)6.52 CelsiusStandard Deviation 2.68
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (5 min after removal)0.12 CelsiusStandard Deviation 0.9
ContraplanarThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (10 min after removal)-0.06 CelsiusStandard Deviation 0.98
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (25 min after removal)0.94 CelsiusStandard Deviation 1.29
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (5 min after removal)2.65 CelsiusStandard Deviation 1.3
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (10 min after removal)0.45 CelsiusStandard Deviation 0.55
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (15 min after removal)1.74 CelsiusStandard Deviation 1.07
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (20 min after removal)1.43 CelsiusStandard Deviation 1.07
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (after electrodes removal)7.46 CelsiusStandard Deviation 1.8
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (5 min after removal)0.61 CelsiusStandard Deviation 0.44
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyUnder the electrode (10 min after removal)2.06 CelsiusStandard Deviation 1.1
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (15 min after removal)0.32 CelsiusStandard Deviation 0.69
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (20 min after removal)0.22 CelsiusStandard Deviation 0.78
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (25 min after removal)0.16 CelsiusStandard Deviation 0.73
LongitudinalThe Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared ThermographyThigh centre (after electrodes removal)0.94 CelsiusStandard Deviation 0.51
Comparison: Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.p-value: <0.05ANOVA
Secondary

Heat Conservation

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.

Time frame: 3 days

Population: Occurred 2 losses to follow up.

ArmMeasureGroupValue (MEAN)Dispersion
CoplanarHeat ConservationUnder the electrode (25 min after removal)1.14 CelsiusStandard Deviation 1.22
CoplanarHeat ConservationUnder the electrode (15 min after removal)1.8 CelsiusStandard Deviation 1.22
CoplanarHeat ConservationThigh centre (5 min after removal)1.33 CelsiusStandard Deviation 0.9
CoplanarHeat ConservationUnder the electrode (5 min after removal)2.76 CelsiusStandard Deviation 1.17
CoplanarHeat ConservationThigh centre (25 min after removal)0.78 CelsiusStandard Deviation 1.17
CoplanarHeat ConservationThigh centre (15 min after removal)1.07 CelsiusStandard Deviation 1.06
CoplanarHeat ConservationThigh centre (10 min after removal)1.17 CelsiusStandard Deviation 1.01
CoplanarHeat ConservationUnder the electrode (20 min after removal)1.41 CelsiusStandard Deviation 1.27
CoplanarHeat ConservationUnder the electrode (10 min after removal)2.15 CelsiusStandard Deviation 1.21
CoplanarHeat ConservationThigh centre (20 min after removal)0.83 CelsiusStandard Deviation 1.19
ContraplanarHeat ConservationUnder the electrode (25 min after removal)1.1 CelsiusStandard Deviation 1.16
ContraplanarHeat ConservationThigh centre (5 min after removal)0.12 CelsiusStandard Deviation 0.9
ContraplanarHeat ConservationUnder the electrode (10 min after removal)1.87 CelsiusStandard Deviation 1.36
ContraplanarHeat ConservationUnder the electrode (20 min after removal)1.28 CelsiusStandard Deviation 1.28
ContraplanarHeat ConservationThigh centre (25 min after removal)-0.09 CelsiusStandard Deviation 1.09
ContraplanarHeat ConservationUnder the electrode (15 min after removal)1.48 CelsiusStandard Deviation 1.29
ContraplanarHeat ConservationUnder the electrode (5 min after removal)2.35 CelsiusStandard Deviation 1.53
ContraplanarHeat ConservationThigh centre (10 min after removal)-0.06 CelsiusStandard Deviation 0.98
ContraplanarHeat ConservationThigh centre (15 min after removal)-0.17 CelsiusStandard Deviation 1.02
ContraplanarHeat ConservationThigh centre (20 min after removal)-0.07 CelsiusStandard Deviation 1.06
LongitudinalHeat ConservationThigh centre (10 min after removal)0.45 CelsiusStandard Deviation 0.55
LongitudinalHeat ConservationThigh centre (15 min after removal)0.32 CelsiusStandard Deviation 0.69
LongitudinalHeat ConservationUnder the electrode (25 min after removal)0.94 CelsiusStandard Deviation 1.29
LongitudinalHeat ConservationUnder the electrode (15 min after removal)1.74 CelsiusStandard Deviation 1.07
LongitudinalHeat ConservationThigh centre (25 min after removal)0.16 CelsiusStandard Deviation 0.73
LongitudinalHeat ConservationThigh centre (5 min after removal)0.61 CelsiusStandard Deviation 0.44
LongitudinalHeat ConservationThigh centre (20 min after removal)0.22 CelsiusStandard Deviation 0.78
LongitudinalHeat ConservationUnder the electrode (20 min after removal)1.43 CelsiusStandard Deviation 1.07
LongitudinalHeat ConservationUnder the electrode (10 min after removal)2.06 CelsiusStandard Deviation 1.1
LongitudinalHeat ConservationUnder the electrode (5 min after removal)2.65 CelsiusStandard Deviation 1.3
Comparison: Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.p-value: <0.05ANOVA
Secondary

Temperature Increase

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.

Time frame: 3 days

Population: Occurred 2 losses to follow up.

ArmMeasureGroupValue (MEAN)Dispersion
CoplanarTemperature IncreaseOn thigh centre, after electrodes removal1.72 CelsiusStandard Deviation 1.01
CoplanarTemperature IncreaseUnder the electrode (after electrodes removal)7.9 CelsiusStandard Deviation 1.76
ContraplanarTemperature IncreaseOn thigh centre, after electrodes removal0.58 CelsiusStandard Deviation 0.99
ContraplanarTemperature IncreaseUnder the electrode (after electrodes removal)6.52 CelsiusStandard Deviation 2.68
LongitudinalTemperature IncreaseOn thigh centre, after electrodes removal0.94 CelsiusStandard Deviation 0.51
LongitudinalTemperature IncreaseUnder the electrode (after electrodes removal)7.46 CelsiusStandard Deviation 1.8
Comparison: Based on a pilot test with eight subjects, we calculated that we would need 18 subjects to give 90% power to detect the most efficient arrangement with a α level of .05. Considering losses to follow up , we increased the sample size by 10%.p-value: <0.05ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026