HumansNCT03601715

Analysis of Human Tissue Temperature After Application of Therapeutic Modalities.

A study testing Coplanar, Contraplanar and Longitudinal in people with Humans and Young Adult, run by Alessandro Haupenthal at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 19 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Humans, Young Adult, Health
What is being tested?: Coplanar, Contraplanar and Longitudinal
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteBrazil
Study dates: 3 Sep 2018to 10 Dec 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 19 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Santa Catarina Federal University
Araranguá, Santa Catarina, 88.906-072

Other trials in Brazil

About this study

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

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.

Read the 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).

Conditions: Humans, Young Adult, Health
Being tested: Coplanar, Contraplanar, Longitudinal
Keywords: Diathermy, Short-Wave Therapy, Body temperature, Skin Temperature
Medical subject headings: Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CoplanarOther
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).
ContraplanarOther
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).
LongitudinalOther
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).

Study groups in NCT03601715
Study group	Role	What they receive
Coplanar	Active comparator	Electrode placed side by side on the same aspect of the right tight. Receives: Other: Coplanar
Contraplanar	Active comparator	Electrode placed over opposite aspects of the right tight. Receives: Other: Contraplanar
Longitudinal	Active comparator	One electrode is placed at each end of the limb in opposite aspects of the tight. Receives: Other: Longitudinal

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 days

Secondary outcomes (2)

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.
Measured: 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.
Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Sep 201810 Dec 2018

First posted26 Jul 2018
Study start3 Sep 2018
Primary completion10 Dec 2018
Study completion10 Dec 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for HumansStudies of the same condition, open and under way.
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
Model description: A randomized single blind, crossover experimental study.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03601715
Sponsor's protocol ID: 1.771.454
Status last verified: Apr 2020
First submitted: 3 Jul 2018
Last updated: 12 May 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Means and standard deviations of temperature change.

Publications

ABIB, R. T. et al. Avaliação da diatermia por ondas curtas contínuo na temperatura superficial do músculo quadríceps. Ciência em Movimento, v. 1, n. 23, p. 69-77, 2010.
BRASILEIRO, J. S.; FARIA, A. F.; QUEIROZ, L. L. Influància do resfriamento e do aquecimento local na flexibilidade dos músculos isquiotibiais. Revista Brasileira de Fisioterapia, v. 11, n. 1, p. 57-61, 2007.
Delpizzo V, Joyner KH. On the safe use of microwave and shortwave diathermy units. Aust J Physiother. 1987;33(3):152-62. doi: 10.1016/S0004-9514(14)60592-4.
PubMed 25025704
Draper DO, Knight K, Fujiwara T, Castel JC. Temperature change in human muscle during and after pulsed short-wave diathermy. J Orthop Sports Phys Ther. 1999 Jan;29(1):13-8; discussion 19-22. doi: 10.2519/jospt.1999.29.1.13.
PubMed 10100117
Draper DO, Miner L, Knight KL, Ricard MD. The Carry-Over Effects of Diathermy and Stretching in Developing Hamstring Flexibility. J Athl Train. 2002 Mar;37(1):37-42.
PubMed 12937442
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Garrett CL, Draper DO, Knight KL. Heat distribution in the lower leg from pulsed short-wave diathermy and ultrasound treatments. J Athl Train. 2000 Jan;35(1):50-5.
PubMed 16558608
Hawkes AR, Draper DO, Johnson AW, Diede MT, Rigby JH. Heating capacity of rebound shortwave diathermy and moist hot packs at superficial depths. J Athl Train. 2013 Jul-Aug;48(4):471-6. doi: 10.4085/1062-6050-48.3.04. Epub 2013 Mar 19.
PubMed 23855362
Ichinoseki-Sekine N, Naito H, Saga N, Ogura Y, Shiraishi M, Giombini A, Giovannini V, Katamoto S. Changes in muscle temperature induced by 434 MHz microwave hyperthermia. Br J Sports Med. 2007 Jul;41(7):425-9. doi: 10.1136/bjsm.2006.032540. Epub 2007 Jan 29.
PubMed 17261552
Peres SE, Draper DO, Knight KL, Ricard MD. Pulsed Shortwave Diathermy and Prolonged Long-Duration Stretching Increase Dorsiflexion Range of Motion More Than Identical Stretching Without Diathermy. J Athl Train. 2002 Mar;37(1):43-50.
PubMed 12937443

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Coplanar Arrangement of Shortwave Diathermy is the Most Efficient in Skin Temperature Change: A Randomized Crossover Trial
ClinicalTrials.gov ID: NCT03601715
Acronym / sponsor ID: 1.771.454
Conditions: Humans, Young Adult, Health
Keywords: Diathermy, Short-Wave Therapy, Body temperature, Skin Temperature
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Alessandro HaupenthalUniversity, hospital or other
Collaborators: Santa Catarina Federal University
Study start: 3 Sep 2018 (actual)
Primary completion: 10 Dec 2018 (actual)
Study completion: 10 Dec 2018 (actual)
First posted: 26 Jul 2018 (actual)
Results: Posted 2 Jan 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 3
Model description: A randomized single blind, crossover experimental study.

Arm	Type	Receives
Coplanar	Active comparator	Other: CoplanarElectrode placed side by side on the same aspect of the right tight.
Contraplanar	Active comparator	Other: ContraplanarElectrode placed over opposite aspects of the right tight.
Longitudinal	Active comparator	Other: LongitudinalOne electrode is placed at each end of the limb in opposite aspects of the tight.

Who may qualify

Ages: 19 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (8 listed)

Skinfold minor than 2cm;
Circulatory system disease;
Ischemic tissue or malignant tumors;
External fixation, metal or pacemaker;
Any thigh open wound;

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
CoplanarThe 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).	Other	Coplanar
ContraplanarThe 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).	Other	Contraplanar
LongitudinalThe 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).	Other	Longitudinal

Primary outcome

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

2 secondary outcomes

Temperature Increase
Time frame: 3 days
Heat Conservation
Time frame: 3 days

Results and safety

Results posted to the registry on 2 Jan 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Coplanar First, Then Contraplanar and at Last Longitudinal	7	7
Contraplanar First, Then Coplanar and at Last Longitudinal	7	7
Longitudinal First, Then Coplanar and at Last Contraplanar	6	6

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

Time frame: 3 days. Mean (Standard Deviation). Unit: Celsius

Measure	Coplanar n = 18	Contraplanar n = 18	Longitudinal n = 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)

Coplanar vs Contraplanar vs Longitudinal: p <0.05, ANOVA

Population analysed: Occurred 2 losses to follow up.

2 secondary outcomes are reported in the full results.

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).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Coplanar	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Contraplanar	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Longitudinal	0 of 18 (0%)	0 of 18 (0%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundABIB, R. T. et al. Avaliação da diatermia por ondas curtas contínuo na temperatura superficial do músculo quadríceps. Ciência em Movimento, v. 1, n. 23, p. 69-77, 2010.
BackgroundBRASILEIRO, J. S.; FARIA, A. F.; QUEIROZ, L. L. Influància do resfriamento e do aquecimento local na flexibilidade dos músculos isquiotibiais. Revista Brasileira de Fisioterapia, v. 11, n. 1, p. 57-61, 2007.
Background: PubMed 25025704Delpizzo V, Joyner KH. On the safe use of microwave and shortwave diathermy units. Aust J Physiother. 1987;33(3):152-62. doi: 10.1016/S0004-9514(14)60592-4.
Background: PubMed 10100117Draper DO, Knight K, Fujiwara T, Castel JC. Temperature change in human muscle during and after pulsed short-wave diathermy. J Orthop Sports Phys Ther. 1999 Jan;29(1):13-8; discussion 19-22. doi: 10.2519/jospt.1999.29.1.13.
Background: PubMed 12937442Draper DO, Miner L, Knight KL, Ricard MD. The Carry-Over Effects of Diathermy and Stretching in Developing Hamstring Flexibility. J Athl Train. 2002 Mar;37(1):37-42.
Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
Background: PubMed 16558608Garrett CL, Draper DO, Knight KL. Heat distribution in the lower leg from pulsed short-wave diathermy and ultrasound treatments. J Athl Train. 2000 Jan;35(1):50-5.
Background: PubMed 23855362Hawkes AR, Draper DO, Johnson AW, Diede MT, Rigby JH. Heating capacity of rebound shortwave diathermy and moist hot packs at superficial depths. J Athl Train. 2013 Jul-Aug;48(4):471-6. doi: 10.4085/1062-6050-48.3.04. Epub 2013 Mar 19.
Background: PubMed 17261552Ichinoseki-Sekine N, Naito H, Saga N, Ogura Y, Shiraishi M, Giombini A, Giovannini V, Katamoto S. Changes in muscle temperature induced by 434 MHz microwave hyperthermia. Br J Sports Med. 2007 Jul;41(7):425-9. doi: 10.1136/bjsm.2006.032540. Epub 2007 Jan 29.
Background: PubMed 12937443Peres SE, Draper DO, Knight KL, Ricard MD. Pulsed Shortwave Diathermy and Prolonged Long-Duration Stretching Increase Dorsiflexion Range of Motion More Than Identical Stretching Without Diathermy. J Athl Train. 2002 Mar;37(1):43-50.
Individual participant dataSharing planned: Yes. Means and standard deviations of temperature change.

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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.

Alessandro Haupenthal, Doctorate study director

Santa Catarina Federal University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Coplanar, Contraplanar and Longitudinal in people with Humans and Young Adult, run by Alessandro Haupenthal 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 4 inclusion and 8 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 12 May 2020. 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?

Yes. Results are posted in the registry (first posted 2 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Most Effective Capacitance Shortwave Technique in Relation to Temperature Increase and Heat Conservation Measured by Infrared Thermography (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03601715, which also lists 10 linked publications.

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 12 May 2020.