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NCT03601715

Analysis of Human Tissue Temperature After Application of Therapeutic Modalities.

Completed NA Results posted Last updated 12 May 2020
What this trial tests

NA trial testing Coplanar in Humans in 20 participants. Completed in 10 December 2018.

Timeline
3 September 2018
Primary endpoint
10 December 2018
10 December 2018

Quick facts

Lead sponsorAlessandro Haupenthal
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingsingle
Primary purposeother
Enrollment20
Start date3 September 2018
Primary completion10 December 2018
Estimated completion10 December 2018
Sites1 location across Brazil

Drugs / interventions tested

Conditions studied

Sponsor

Alessandro Haupenthal

Who can join

Adults 19 to 40, male only, with Humans or Young Adult. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Thigh centre (after electrodes removal)
GroupValue95% CI
Coplanar1.72± 1.01
Contraplanar0.58± 0.99
Longitudinal0.94± 0.51
Under the electrode (after electrodes removal)
GroupValue95% CI
Coplanar7.9± 1.76
Contraplanar6.52± 2.68
Longitudinal7.46± 1.8
Thigh centre (5 min after removal)
GroupValue95% CI
Coplanar1.33± 0.9
Contraplanar0.12± 0.9
Longitudinal0.61± 0.44
Under the electrode (5 min after removal)
GroupValue95% CI
Coplanar2.76± 1.17
Contraplanar2.35± 1.53
Longitudinal2.65± 1.3
Thigh centre (10 min after removal)
GroupValue95% CI
Coplanar1.17± 1.01
Contraplanar-0.06± 0.98
Longitudinal0.45± 0.55
Under the electrode (10 min after removal)
GroupValue95% CI
Coplanar2.15± 1.21
Contraplanar1.87± 1.36
Longitudinal2.06± 1.1
Thigh centre (15 min after removal)
GroupValue95% CI
Coplanar1.07± 1.06
Contraplanar-0.17± 1.02
Longitudinal0.32± 0.69
Under the electrode (15 min after removal)
GroupValue95% CI
Coplanar1.8± 1.22
Contraplanar1.48± 1.29
Longitudinal1.74± 1.07
Temperature Increase Secondary · 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.

On thigh centre, after electrodes removal
GroupValue95% CI
Coplanar1.72± 1.01
Contraplanar0.58± 0.99
Longitudinal0.94± 0.51
Under the electrode (after electrodes removal)
GroupValue95% CI
Coplanar7.9± 1.76
Contraplanar6.52± 2.68
Longitudinal7.46± 1.8
Heat Conservation Secondary · 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.

Thigh centre (5 min after removal)
GroupValue95% CI
Coplanar1.33± 0.9
Contraplanar0.12± 0.9
Longitudinal0.61± 0.44
Under the electrode (5 min after removal)
GroupValue95% CI
Coplanar2.76± 1.17
Contraplanar2.35± 1.53
Longitudinal2.65± 1.3
Thigh centre (10 min after removal)
GroupValue95% CI
Coplanar1.17± 1.01
Contraplanar-0.06± 0.98
Longitudinal0.45± 0.55
Under the electrode (10 min after removal)
GroupValue95% CI
Coplanar2.15± 1.21
Contraplanar1.87± 1.36
Longitudinal2.06± 1.1
Thigh centre (15 min after removal)
GroupValue95% CI
Coplanar1.07± 1.06
Contraplanar-0.17± 1.02
Longitudinal0.32± 0.69
Under the electrode (15 min after removal)
GroupValue95% CI
Coplanar1.8± 1.22
Contraplanar1.48± 1.29
Longitudinal1.74± 1.07
Thigh centre (20 min after removal)
GroupValue95% CI
Coplanar0.83± 1.19
Contraplanar-0.07± 1.06
Longitudinal0.22± 0.78
Under the electrode (20 min after removal)
GroupValue95% CI
Coplanar1.41± 1.27
Contraplanar1.28± 1.28
Longitudinal1.43± 1.07

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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