Analysis of Human Tissue Temperature After Application of Therapeutic Modalities.

Study Overview
=================
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).

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

Conditions
-----------------
Humans, Young Adult, Health

Intervention / Treatment
-----------------
* Other: Coplanar
* Other: Contraplanar
* Other: Longitudinal


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomized single blind, crossover experimental study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Coplanar<br>Electrode placed side by side on the same aspect of the right tight. | Other: Coplanar<br>* 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).<br>|
| Active Comparator: Contraplanar<br>Electrode placed over opposite aspects of the right tight. | Other: Contraplanar<br>* 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).<br>|
| Active Comparator: Longitudinal<br>One electrode is placed at each end of the limb in opposite aspects of the tight. | Other: Longitudinal<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 days | 
| 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. | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diathermy, Short-Wave Therapy, Body temperature, Skin Temperature