NCT05892497

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2023

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

May 26, 2023

Last Update Submit

July 24, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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)

  • 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 Outcomes (4)

  • Countermovement jump (cm)

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

  • Changes in electromyographic activity during countermovement jump (μ/v)

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

  • Changes in isometric leg extension (Newtons)

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

  • Changes in electromyographic activity during isometric leg extension (μ/v)

    Baseline(immediately before intervention) and post intervention (immediately after intervention)

Study Arms (2)

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.

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.

Other: Tecartherapy

Interventions

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

Sham groupTecartherpay Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, 08195, Spain

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 7, 2023

Study Start

August 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 10, 2023

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations