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Tecarterapy on the Performance of Amateur Athletes.

Primary Purpose

Diathermy Plate Burn, Sports Physical Therapy

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Tecartherapy
Sponsored by
Maxim Canet Vintró
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diathermy Plate Burn

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Athletes between 18 and 30 years of age (athletics and field sports such as soccer, basketball, rugby... that may involve sprinting) federated and competing in university or national amateur leagues that perform sprinting and jumping in their sports practice. Active participation in regional, national or international competitions. Study participants must have signed the informed consent form in order to evaluate their inclusion in the study. Exclusion Criteria: Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity. Not understanding the information provided by the therapist. Participate in other research studies. Being under a pharmacological medical treatment that may interfere with the measures, such as treatment with anticonvulsants, antidepressants, etc.

Sites / Locations

  • Universitat Internacional de CatalunyaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Tecartherpay Group

Sham group

Arm Description

A single 25-minute tecartherapy procedure will be performed in both legs with the T-Plus Wintecare® machine. The configuration of the tecartherapy programme will be in 40 watts resistive mode for each muscle.

The same procedure of the intervention group will be performed but with the tecartherapy machine without power (sham). The machine will be on but no power will be supplied.

Outcomes

Primary Outcome Measures

Change in 30 meters sprint (seconds)
Photoelectric cells will be used to measure the time required to complete a 30-meter sprint.
Changes in electromyographic activity during sprint (μ/v)
The mean electromyographic activity of the quadriceps musculature during sprint will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).

Secondary Outcome Measures

Countermovement jump (cm)
A bipodal jump will be performed and measured with the validated application "MyJump 2"
Changes in electromyographic activity during countermovement jump (μ/v)
The mean electromyographic activity of the quadriceps musculature during the jump will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).
Changes in isometric leg extension (Newtons)
A precision dynamometer (Microfeet II) will be used and the maximum force during an isometric contraction of this musculature during 5 seconds of the quadriceps will be analyzed.
Changes in electromyographic activity during isometric leg extension (μ/v)
The mean electromyographic activity of the quadriceps musculature during the isometric leg extension will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).

Full Information

First Posted
May 26, 2023
Last Updated
July 24, 2023
Sponsor
Maxim Canet Vintró
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1. Study Identification

Unique Protocol Identification Number
NCT05892497
Brief Title
Tecarterapy on the Performance of Amateur Athletes.
Official Title
Effectiveness of Tecarterapy on the Performance of Amateur Athletes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
September 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Maxim Canet Vintró

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Physical therapies based on electrical or electromagnetic stimulation have been used in rehabilitation, in some cases combining electrical therapy with radiofrequency. Specifically, resistive capacitive electrical transfer therapy (CRet) has been used in physical rehabilitation and sports medicine to treat muscle, bone, ligament and tendon injuries. CRet is a non-invasive electrothermal therapy classified as deep thermotherapy, which is based on the application of electrical currents within the radiofrequency range of 300 kHz - 1.2 MHz. While the heat conducted by surface thermotherapy cannot reach the muscle due to the electrical resistance of the tissues, the capacitive-resistive electrical currents in CRet therapy can generate heating of deep muscle tissues, which in turn improves haemoglobin saturation. In Europe, CRet is widely used in various medical rehabilitation processes. The physiological effects of this type of physiotherapy are generated by the application of an electromagnetic field with a frequency of approximately 0.5 MHz to the human body. The effects attributed to this technique include increased deep and superficial blood circulation, vasodilatation, increased temperature, removal of excess fluid and increased cell proliferation. Some of these reactions, such as increased blood perfusion, are known to be related to the increase in temperature, but others, such as increased cell proliferation, appear to be primarily related to the passage of current. It is also true that this increase in tissue temperature, generated through the application of the device, is a physical reaction to the passage of current (Joule effect). Although there is already clinical literature supporting this mechanism, the amount of energy and current that must be transferred to obtain the desired temperature rise is unknown. Moreover, the control of these reactions, by adjusting parameters such as absorbed power and electrode position, is still largely based on the empirical experience of therapists . Recently, new cadaveric publications have been generated, which support the mechanisms of current flow and thermal changes in this situation. Against this background, in which thermal effects, current passage and symptomatic improvements have been demonstrated in patients with pathology, the possibility that these treatments may improve functional sporting abilities is raised. This hypothesis arises from the fact that current flow and thermal changes have been directly related to viscoelastic changes in capsular and muscle tissue. To date, there is no study that has assessed whether this therapy generates any change in functional variables related to sports performance in professional athletes.
Detailed Description
Physical therapies based on electrical or electromagnetic stimulation have been used in rehabilitation, in some cases combining electrical therapy with radiofrequency. Specifically, resistive capacitive electrical transfer therapy (CRet) has been used in physical rehabilitation and sports medicine to treat muscle, bone, ligament and tendon injuries. CRet is a non-invasive electrothermal therapy classified as deep thermotherapy, which is based on the application of electrical currents within the radiofrequency range of 300 kHz - 1.2 MHz. While the heat conducted by surface thermotherapy cannot reach the muscle due to the electrical resistance of the tissues, the capacitive-resistive electrical currents in CRet therapy can generate heating of deep muscle tissues, which in turn improves haemoglobin saturation. In Europe, CRet is widely used in various medical rehabilitation processes. The physiological effects of this type of physiotherapy are generated by the application of an electromagnetic field with a frequency of approximately 0.5 MHz to the human body. The effects attributed to this technique include increased deep and superficial blood circulation, vasodilatation, increased temperature, removal of excess fluid and increased cell proliferation. Some of these reactions, such as increased blood perfusion, are known to be related to the increase in temperature, but others, such as increased cell proliferation, appear to be primarily related to the passage of current. It is also true that this increase in tissue temperature, generated through the application of the device, is a physical reaction to the passage of current (Joule effect). Although there is already clinical literature supporting this mechanism, the amount of energy and current that must be transferred to obtain the desired temperature rise is unknown. Moreover, the control of these reactions, by adjusting parameters such as absorbed power and electrode position, is still largely based on the empirical experience of therapists . Recently, new cadaveric publications have been generated, which support the mechanisms of current flow and thermal changes in this situation. Against this background, in which thermal effects, current passage and symptomatic improvements have been demonstrated in patients with pathology, the possibility that these treatments may improve functional sporting abilities is raised. This hypothesis arises from the fact that current flow and thermal changes have been directly related to viscoelastic changes in capsular and muscle tissue. To date, there is no study that has assessed whether this therapy generates any change in functional variables related to sports performance in professional athletes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diathermy Plate Burn, Sports Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tecartherpay Group
Arm Type
Experimental
Arm Description
A single 25-minute tecartherapy procedure will be performed in both legs with the T-Plus Wintecare® machine. The configuration of the tecartherapy programme will be in 40 watts resistive mode for each muscle.
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
The same procedure of the intervention group will be performed but with the tecartherapy machine without power (sham). The machine will be on but no power will be supplied.
Intervention Type
Other
Intervention Name(s)
Tecartherapy
Intervention Description
The tecartherapy intervention was with a deep diathermy machine applied to the patient's lower extremity for 30 minutes.
Primary Outcome Measure Information:
Title
Change in 30 meters sprint (seconds)
Description
Photoelectric cells will be used to measure the time required to complete a 30-meter sprint.
Time Frame
Baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Changes in electromyographic activity during sprint (μ/v)
Description
The mean electromyographic activity of the quadriceps musculature during sprint will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).
Time Frame
Baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary Outcome Measure Information:
Title
Countermovement jump (cm)
Description
A bipodal jump will be performed and measured with the validated application "MyJump 2"
Time Frame
Baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Changes in electromyographic activity during countermovement jump (μ/v)
Description
The mean electromyographic activity of the quadriceps musculature during the jump will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).
Time Frame
Baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Changes in isometric leg extension (Newtons)
Description
A precision dynamometer (Microfeet II) will be used and the maximum force during an isometric contraction of this musculature during 5 seconds of the quadriceps will be analyzed.
Time Frame
Baseline(immediately before intervention) and post intervention (immediately after intervention)
Title
Changes in electromyographic activity during isometric leg extension (μ/v)
Description
The mean electromyographic activity of the quadriceps musculature during the isometric leg extension will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).
Time Frame
Baseline(immediately before intervention) and post intervention (immediately after intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Athletes between 18 and 30 years of age (athletics and field sports such as soccer, basketball, rugby... that may involve sprinting) federated and competing in university or national amateur leagues that perform sprinting and jumping in their sports practice. Active participation in regional, national or international competitions. Study participants must have signed the informed consent form in order to evaluate their inclusion in the study. Exclusion Criteria: Volunteers who have suffered a sports injury during the last two months or are unable to perform physical activity. Not understanding the information provided by the therapist. Participate in other research studies. Being under a pharmacological medical treatment that may interfere with the measures, such as treatment with anticonvulsants, antidepressants, etc.
Facility Information:
Facility Name
Universitat Internacional de Catalunya
City
Sant Cugat Del Vallès
State/Province
Barcelona
ZIP/Postal Code
08195
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Albert Pérez-Bellmunt, PhD
Phone
636817297
Ext
+34
Email
aperez@uic.es

12. IPD Sharing Statement

Learn more about this trial

Tecarterapy on the Performance of Amateur Athletes.

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