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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05892497
Other study ID # CBAS-2021-08
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date September 10, 2023

Study information

Verified date July 2023
Source Universitat Internacional de Catalunya
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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, 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 10, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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.

Study Design


Intervention

Other:
Tecartherapy
The tecartherapy intervention was with a deep diathermy machine applied to the patient's lower extremity for 30 minutes.

Locations

Country Name City State
Spain Universitat Internacional de Catalunya Sant Cugat Del Vallès Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Maxim Canet Vintró

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in 30 meters sprint (seconds) Photoelectric cells will be used to measure the time required to complete a 30-meter sprint. Baseline(immediately before intervention) and post intervention (immediately after intervention)
Primary 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). Baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary Countermovement jump (cm) A bipodal jump will be performed and measured with the validated application "MyJump 2" Baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary 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). Baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary 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. Baseline(immediately before intervention) and post intervention (immediately after intervention)
Secondary 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). Baseline(immediately before intervention) and post intervention (immediately after intervention)
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