Diathermy Plate BurnNCT05892497
Tecarterapy on the Performance of Amateur Athletes.
A study testing Tecartherapy in people with Diathermy Plate Burn and Sports Physical Therapy, run by Maxim Canet Vintró at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Diathermy Plate Burn, Sports Physical Therapy
- What is being tested?
- Tecartherapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2023to 10 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Albert Pérez-Bellmunt, PhD, 636817297 ext. +34, aperez@uic.es
About this study
Official title: Effectiveness of Tecarterapy on the Performance of Amateur Athletes
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.
Read more
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.
Read the 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.
- Conditions
- Diathermy Plate Burn, Sports Physical Therapy
- Being tested
- Tecartherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TecartherapyOther
The tecartherapy intervention was with a deep diathermy machine applied to the patient's lower extremity for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Tecartherpay Group | Experimental | 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. Receives: Other: Tecartherapy |
| Sham group | Sham comparator | 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. Receives: Other: Tecartherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 30 meters sprint (seconds)
Photoelectric cells will be used to measure the time required to complete a 30-meter sprint.
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
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).
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary outcomes (4)
Countermovement jump (cm)
A bipodal jump will be performed and measured with the validated application "MyJump 2"
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
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).
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
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.
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
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).
Measured: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start1 Aug 2023 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion10 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diathermy Plate BurnStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maxim Canet Vintró
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Maxim Canet Vintró, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05892497
- Sponsor's protocol ID
- CBAS-2021-08
- Status last verified
- Jul 2023
- First submitted
- 26 May 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tecarterapy on the Performance of Amateur Athletes
- ClinicalTrials.gov ID
- NCT05892497
- Acronym / sponsor ID
- CBAS-2021-08
- Conditions
- Diathermy Plate Burn, Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maxim Canet VintróUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 10 Sep 2023 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tecartherpay Group | Experimental | Other: TecartherapyA 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. |
| Sham group | Sham comparator | Other: TecartherapyThe 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| TecartherapyThe tecartherapy intervention was with a deep diathermy machine applied to the patient's lower extremity for 30 minutes. | Other | Sham group, Tecartherpay Group |
Primary outcome
Change in 30 meters sprint (seconds)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Photoelectric cells will be used to measure the time required to complete a 30-meter sprint.
Changes in electromyographic activity during sprint (μ/v)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
The mean electromyographic activity of the quadriceps musculature during sprint will be measured with The mDurance® system device (mDurance Solutions SL, Granada, Spain).
4 secondary outcomes
Countermovement jump (cm)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in electromyographic activity during countermovement jump (μ/v)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in isometric leg extension (Newtons)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Changes in electromyographic activity during isometric leg extension (μ/v)
Time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tecartherapy in people with Diathermy Plate Burn and Sports Physical Therapy, run by Maxim Canet Vintró at 1 site in Spain.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 25 Jul 2023. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 30 meters sprint (seconds) (time frame: Baseline(immediately before intervention) and post intervention (immediately after intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2023.