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Analysis of Human Tissue Temperature After Application of Therapeutic Modalities.

Sponsor
Alessandro Haupenthal (Other)
Overall Status
Completed
CT.gov ID
NCT03601715
Collaborator
Santa Catarina Federal University (Other)
20
Enrollment
1
Location
3
Arms
3.2
Actual Duration (Months)
6.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Coplanar
  • Other: Contraplanar
  • Other: Longitudinal
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A randomized single blind, crossover experimental study.A randomized single blind, crossover experimental study.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Coplanar Arrangement of Shortwave Diathermy is the Most Efficient in Skin Temperature Change: A Randomized Crossover Trial
Actual Study Start Date :
Sep 3, 2018
Actual Primary Completion Date :
Dec 10, 2018
Actual Study Completion Date :
Dec 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Coplanar

Electrode placed side by side on the same aspect of the right tight.

Other: Coplanar
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).
Active Comparator: Contraplanar

Electrode placed over opposite aspects of the right tight.

Other: Contraplanar
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).
Active Comparator: Longitudinal

One electrode is placed at each end of the limb in opposite aspects of the tight.

Other: Longitudinal
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).

Outcome Measures

Primary Outcome Measures

  1. The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography [3 days]

    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.

Secondary Outcome Measures

  1. Temperature Increase [3 days]

    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.

  2. Heat Conservation [3 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Santa Catarina Federal University Araranguá SC Brazil 88.906-072

Sponsors and Collaborators

  • Alessandro Haupenthal
  • Santa Catarina Federal University

Investigators

  • Study Director: Alessandro Haupenthal, Doctorate, Santa Catarina Federal University

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Alessandro Haupenthal, Principal Investigator, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier:
NCT03601715
Other Study ID Numbers:
  • 1.771.454
First Posted:
Jul 26, 2018
Last Update Posted:
May 12, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alessandro Haupenthal, Principal Investigator, Universidade Federal de Santa Catarina
Diathermy
Short-Wave Therapy
Body temperature
Skin Temperature

Study Results

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 Detail All the twenty health enrolled male subjects met the inclusion criteria and were randomly allocated an order in which treatments were received.
Arm/Group Title Coplanar First, Then Contraplanar and at Last Longitudinal Contraplanar First, Then Coplanar and at Last Longitudinal Longitudinal First, Then Coplanar and at Last Contraplanar
Arm/Group Description 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. 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. 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.
Period Title: First Intervention
STARTED 7 7 6
COMPLETED 7 7 6
NOT COMPLETED 0 0 0
Period Title: First Intervention
STARTED 7 7 6
COMPLETED 7 7 6
NOT COMPLETED 0 0 0
Period Title: First Intervention
STARTED 7 7 6
COMPLETED 6 6 6
NOT COMPLETED 1 1 0
Period Title: First Intervention
STARTED 6 6 6
COMPLETED 6 6 6
NOT COMPLETED 0 0 0
Period Title: First Intervention
STARTED 6 6 6
COMPLETED 6 6 6
NOT COMPLETED 0 0 0

Baseline Characteristics

Arm/Group Title Coplanar First, Then Contraplanar and at Last Longitudinal Contraplanar First, Then Coplanar and at Last Longitudinal Longitudinal First, Then Coplanar and at Last Contraplanar Total
Arm/Group Description 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. 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. 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 of all reporting groups
Overall Participants 7 7 6 20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
21.7
(1.6)
22.2
(1.79)
20
(2.09)
21.4
(2.09)
Sex: Female, Male (Count of Participants)
Female
0
0%
0
0%
0
0%
0
0%
Male
7
100%
7
100%
6
100%
20
100%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
Brazil
7
100%
7
100%
6
100%
20
100%
Height (meters) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meters]
1.74
(0.08)
1.75
(0.04)
1.78
(0.08)
1.76
(0.07)
Mass (Kilograms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms]
74
(12.02)
73
(14.4)
72.6
(6.63)
73.2
(10.6)
Body mass index (Kilograms/meters²) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kilograms/meters²]
24.2
(3.09)
23.4
(3.37)
22.9
(2.2)
23.6
(2.46)

Outcome Measures

1. Primary Outcome
Title The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography
Description 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

Outcome Measure Data

Analysis Population Description
Occurred 2 losses to follow up.
Arm/Group Title Coplanar Contraplanar Longitudinal
Arm/Group Description 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. 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. 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.
Measure Participants 18 18 18
Thigh centre (after electrodes removal)
1.72
(1.01)
0.58
(0.99)
0.94
(0.51)
Under the electrode (after electrodes removal)
7.9
(1.76)
6.52
(2.68)
7.46
(1.8)
Thigh centre (5 min after removal)
1.33
(0.9)
0.12
(0.9)
0.61
(0.44)
Under the electrode (5 min after removal)
2.76
(1.17)
2.35
(1.53)
2.65
(1.3)
Thigh centre (10 min after removal)
1.17
(1.01)
-0.06
(0.98)
0.45
(0.55)
Under the electrode (10 min after removal)
2.15
(1.21)
1.87
(1.36)
2.06
(1.1)
Thigh centre (15 min after removal)
1.07
(1.06)
-0.17
(1.02)
0.32
(0.69)
Under the electrode (15 min after removal)
1.8
(1.22)
1.48
(1.29)
1.74
(1.07)
Thigh centre (20 min after removal)
0.83
(1.19)
-0.07
(1.06)
0.22
(0.78)
Under the electrode (20 min after removal)
1.41
(1.27)
1.28
(1.28)
1.43
(1.07)
Thigh centre (25 min after removal)
0.78
(1.17)
-0.09
(1.09)
0.16
(0.73)
Under the electrode (25 min after removal)
1.14
(1.22)
1.1
(1.16)
0.94
(1.29)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coplanar, Contraplanar, Longitudinal
Comments 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%.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments Bonferroni post-hoc tests.
Method ANOVA
Comments
Other Statistical Analysis Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).
2. Secondary Outcome
Title Temperature Increase
Description 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

Outcome Measure Data

Analysis Population Description
Occurred 2 losses to follow up.
Arm/Group Title Coplanar Contraplanar Longitudinal
Arm/Group Description 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. 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. 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.
Measure Participants 18 18 18
On thigh centre, after electrodes removal
1.72
(1.01)
0.58
(0.99)
0.94
(0.51)
Under the electrode (after electrodes removal)
7.9
(1.76)
6.52
(2.68)
7.46
(1.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coplanar, Contraplanar, Longitudinal
Comments 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%.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments Bonferroni post-hoc tests.
Method ANOVA
Comments
Other Statistical Analysis Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).
3. Secondary Outcome
Title Heat Conservation
Description 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

Outcome Measure Data

Analysis Population Description
Occurred 2 losses to follow up.
Arm/Group Title Coplanar Contraplanar Longitudinal
Arm/Group Description 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. 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. 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.
Measure Participants 18 18 18
Thigh centre (5 min after removal)
1.33
(0.9)
0.12
(0.9)
0.61
(0.44)
Under the electrode (5 min after removal)
2.76
(1.17)
2.35
(1.53)
2.65
(1.3)
Thigh centre (10 min after removal)
1.17
(1.01)
-0.06
(0.98)
0.45
(0.55)
Under the electrode (10 min after removal)
2.15
(1.21)
1.87
(1.36)
2.06
(1.1)
Thigh centre (15 min after removal)
1.07
(1.06)
-0.17
(1.02)
0.32
(0.69)
Under the electrode (15 min after removal)
1.8
(1.22)
1.48
(1.29)
1.74
(1.07)
Thigh centre (20 min after removal)
0.83
(1.19)
-0.07
(1.06)
0.22
(0.78)
Under the electrode (20 min after removal)
1.41
(1.27)
1.28
(1.28)
1.43
(1.07)
Thigh centre (25 min after removal)
0.78
(1.17)
-0.09
(1.09)
0.16
(0.73)
Under the electrode (25 min after removal)
1.14
(1.22)
1.1
(1.16)
0.94
(1.29)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Coplanar, Contraplanar, Longitudinal
Comments 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%.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments Bonferroni post-hoc tests.
Method ANOVA
Comments
Other Statistical Analysis Effect size was calculated through partial eta squared and correlated using Cohen index (.1 to .3 as small, .3 to .5 as medium, and over .5 as large).

Adverse Events

Time Frame The participants were monitored for adverse events over the duration of treatment (at least 5 days, considering the washout period minimum of 1 day).
Adverse Event Reporting Description Other adverse events refers to burns.
Arm/Group Title Coplanar Contraplanar Longitudinal
Arm/Group Description 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. 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. 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.
All Cause Mortality
Coplanar Contraplanar Longitudinal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/20 (0%) 0/20 (0%) 0/18 (0%)
Serious Adverse Events
Coplanar Contraplanar Longitudinal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/20 (0%) 0/20 (0%) 0/18 (0%)
Other (Not Including Serious) Adverse Events
Coplanar Contraplanar Longitudinal
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/20 (0%) 0/20 (0%) 0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Inaihá Benincá
Organization Federal University of Santa Catarina
Phone (+55 48) 3721-6255
Email inaiha.b@gmail.com
Responsible Party:
Alessandro Haupenthal, Principal Investigator, Universidade Federal de Santa Catarina
ClinicalTrials.gov Identifier:
NCT03601715
Other Study ID Numbers:
  • 1.771.454
First Posted:
Jul 26, 2018
Last Update Posted:
May 12, 2020
Last Verified:
Apr 1, 2020