NCT03601715

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 3, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

September 3, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 2, 2020

Completed
Last Updated

May 12, 2020

Status Verified

April 1, 2020

Enrollment Period

3 months

First QC Date

July 3, 2018

Results QC Date

November 23, 2019

Last Update Submit

April 29, 2020

Conditions

Keywords

DiathermyShort-Wave TherapyBody temperatureSkin Temperature

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Temperature Increase

    3 days

  • Heat Conservation

    3 days

Study Arms (3)

Coplanar

ACTIVE COMPARATOR

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

Other: Coplanar

Contraplanar

ACTIVE COMPARATOR

Electrode placed over opposite aspects of the right tight.

Other: Contraplanar

Longitudinal

ACTIVE COMPARATOR

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

Other: Longitudinal

Interventions

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).

Coplanar

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).

Contraplanar

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).

Longitudinal

Eligibility Criteria

Age19 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Catarina Federal University

Araranguá, Santa Catarina, 88.906-072, Brazil

Location

Related Publications (10)

  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 25025704BACKGROUND
  • 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.

    PMID: 10100117BACKGROUND
  • 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.

    PMID: 12937442BACKGROUND
  • 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.

    PMID: 17695343BACKGROUND
  • 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.

    PMID: 16558608BACKGROUND
  • 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.

    PMID: 23855362BACKGROUND
  • 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.

    PMID: 17261552BACKGROUND
  • 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.

    PMID: 12937443BACKGROUND

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Inaihá Benincá
Organization
Federal University of Santa Catarina

Study Officials

  • Alessandro Haupenthal, Doctorate

    Santa Catarina Federal University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: A randomized single blind, crossover experimental study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 26, 2018

Study Start

September 3, 2018

Primary Completion

December 10, 2018

Study Completion

December 10, 2018

Last Updated

May 12, 2020

Results First Posted

January 2, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

Means and standard deviations of temperature change.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Immediately following publication. No end date.
Access Criteria
Anyone who wishes to access the data.

Locations