TECAR TherapyNCT04801628
Immediate Effects of TECAR Therapy on the Quadriceps Muscle Performance in Athlete: A Randomized Crossover Trial
A study testing Active Tecar in people with TECAR Therapy and Muscle Performance, run by Cairo University at 1 site in Egypt.
Trial summary
The experimental procedures will be composed of two sessions. The following steps will be constituted the first session: warm-up on the cycle ergometer, and familiarization with the isokinetic dynamometer then baseline measurement of isokinetic parameters. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- TECAR Therapy, Muscle Performance, Athletes
- What is being tested?
- Active Tecar
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Mar 2021to 10 Jun 2021
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged between 23 and 35 years.
- body mass index of 20 to 25 kg/cm2
- classified as irregularly active or active, who performed physical activity with a frequency of at least five times a week, totaling a minimum of 150 min per week, according to International Physical Activity Questionnaire (IPAQ)-Short Version and reports by participants were included.
Who cannot join
- Those with previous musculoskeletal injury to the quadriceps femoris
- Participants with hypersensitivity
- A history of arthritis, injury, or surgery on the knee or hip
- Participants that will be had a metal insert in the area requiring therapy were the excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate Effects of TECAR Therapy on the Quadriceps Muscle Performance in Athlete
The experimental procedures will be composed of two sessions. The following steps will be constituted the first session: warm-up on the cycle ergometer, and familiarization with the isokinetic dynamometer then baseline measurement of isokinetic parameters. Afterward, the placebo or active TECAR therapy will be applied (according to the randomization). At the end, isokinetic parameters will be taken again. After 7 days, the second session will be performed following identical procedures to the first session. However, an inverse mode of TECAR therapy from the first session (placebo or active) will be applied for each individual. The two sessions will be held 7 days apart, either on a Sunday or Tuesday. Procedures are summarized in Figure 1. The dominant lower limb test will be used to elect the lower limb selected for isokinetic Dynamometer.
Figure 1: Timeline for the period of evaluation of groups (Active and Placebo TECAR).
Read more
Muscle performance measurement by Isokinetic Dynamometer:
The quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer (Biodex Medical System, Shiley, NY, USA, linked to IBM PC-computer software). Calibration of the Biodex for torque and angular speed will be done according to the prescribed manufacturer's guidelines before each recording session. Prior to assessment, the volunteers held a 5-min cycle ergometer warm up (speed in the range of 60-70 rpm and no load). After that, participants will be positioned with hip angle of 100o on the previously calibrated isokinetic dynamometer and will be properly aligned and stabilized with straps in order to avoid possible compensatory movements. Thus, the dominant knee axis (lateral epicondyle of the femur) of each subject was adjusted to the dynamometer rotation axis. The lever arm of the equipment was fixed approximately 2 cm above the tibial malleolus. The chair height, backrest distance, seat angle, and dynamometer base were adjusted for each subject and noted for the second session. Before starting the recording of isokinetic muscle performance, there will be a familiarization period with the apparatus consisting of five submaximal voluntary concentric muscle contractions in the full range of standardized and preprogrammed motion (90-20°) according to the guideline procedures of the dynamometer, with a constant angular velocity of 180°/s. the isokinetic protocol will be performed with a set of 60 concentric/eccentric contractions of quadriceps. The participants will be visually and verbally encouraged throughout the test protocol to achieve maximum effort from the beginning. The muscle performance, in terms of work fatigue index, peak torque, average power, and total work of the knee extensor muscles, will be evaluated by isokinetic dynamometry in accordance with the guidelines of the equipment manufacturer (Biodex Medical System Inc.).
Experimental protocol of TECAR therapy:
Immediately after the baseline measurement of muscle performance of each session, the participants will be received placebo or active TECAR therapy.
In this experiment, Transfer Electrode Capacitive and Resistive (TECAR) Therapy (radio frequency therapy; INDIBA, Spain) will be used. TECAR therapy is a systematic treatment for providing capacitive energy transfer (CET) and resistive energy transfer (RET). In CET mode, heat transfer is concentrated on the skin and superficial muscles, which are tissue with high electrolytes, while the RET mode focuses heat transfer on bones, tendons, joints, and deep muscles. In this study, both CET and RET modes will be applied to the participant' quadriceps for 15-20 minutes at stable frequency of 448 KHz. According to the manufacturer's guidelines for safety, the CET mode will be first implemented for 5 minutes. Then will be continued in RET mode using for the rest of the treatment. Participants will be asked to lie down comfortably, and treatment will be beginning.
The intensity of the current will be set at the level of comfort between 0%-100%, averaging about 40%. TECAR therapy will be applied by a physical therapist for all participants.
- Conditions
- TECAR Therapy, Muscle Performance, Athletes
- Being tested
- Active Tecar, Placebo Tecar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active TecarDevice
Active Tecar
Placebo TecarDevice
Placebo Tecar
| Study group | Role | What they receive |
|---|---|---|
| Active Tecar | Active comparator | Transfer Electrode Capacitive and Resistive (TECAR) Therapy (radio frequency therapy; INDIBA, Spain) will be used. In CET mode, heat transfer is concentrated on the skin and superficial muscles, which are tissue with high electrolytes, while the RET mode focuses heat transfer on bones, tendons, joints, and deep muscles. In this study, both CET and RET modes will be applied to the participant' quadriceps for 15-20 minutes at stable frequency of 448 KHz. According to the manufacturer's guidelines for safety, the CET mode will be first implemented for 5 minutes. Then will be continued in RET mode using for the rest of the treatment. Participants will be asked to lie down comfortably, and treatment will be beginning.
The intensity of the current will be set at the level of comfort between 0%-100%, averaging about 40%. TECAR therapy will be applied by a physical therapist for all participants. Receives: Device: Active Tecar |
| Placebo Tecar | Placebo comparator | the same procedure as in active Tecar but the device not provide any radio frequency Receives: Device: Placebo Tecar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak torque of the quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer
The quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer
Measured: 5 minutes from application of treatment
total work
The total work of quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer
Measured: 5 minutes from application of treatment
Secondary outcomes (1)
work fatigue index
The work fatigue index of quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer
Measured: 5 minutes from application of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2021
- Study start12 Mar 2021 (estimated)
- Primary completion12 Mar 2021 (estimated)
- Study completion10 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TECAR TherapyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamada Ahmed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04801628
- Sponsor's protocol ID
- P.T.REC/012/003025
- Status last verified
- Feb 2021
- First submitted
- 11 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effects of TECAR Therapy on the Quadriceps Muscle Performance in Athlete
- ClinicalTrials.gov ID
- NCT04801628
- Acronym / sponsor ID
- P.T.REC/012/003025
- Conditions
- TECAR Therapy, Muscle Performance, Athletes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 12 Mar 2021 (estimated)
- Primary completion
- 12 Mar 2021 (estimated)
- Study completion
- 10 Jun 2021 (estimated)
- First posted
- 17 Mar 2021 (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.
The experimental procedures will be composed of two sessions. The following steps will be constituted the first session: warm-up on the cycle ergometer, and familiarization with the isokinetic dynamometer then baseline measurement of isokinetic parameters. Afterward, the placebo or active TECAR therapy will be applied (according to the randomization). At the end, isokinetic parameters will be taken again. After 7 days, the second session will be performed following identical procedures to the first session. However, an inverse mode of TECAR therapy from the first session (placebo or active) will be applied for each individual. The two sessions will be held 7 days apart, either on a Sunday or Tuesday. Procedures are summarized in Figure 1. The dominant lower limb test will be used to elect the lower limb selected for isokinetic Dynamometer.
Figure 1: Timeline for the period of evaluation of groups (Active and Placebo TECAR).
Muscle performance measurement by Isokinetic Dynamometer:
The quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer (Biodex Medical System, Shiley, NY, USA, linked to IBM PC-computer software). Calibration of the Biodex for torque and angular speed will be done according to the prescribed manufacturer's guidelines before each recording session. Prior to assessment, the volunteers held a 5-min cycle ergometer warm up (speed in the range of 60-70 rpm and no load). After that, participants will be positioned with hip angle of 100o on the previously calibrated isokinetic dynamometer and will be properly aligned and stabilized with straps in order to avoid possible compensatory movements. Thus, the dominant knee axis (lateral epicondyle of the femur) of each subject was adjusted to the dynamometer rotation axis. The lever arm of the equipment was fixed approximately 2 cm above the tibial malleolus. The chair height, backrest distance, seat angle, and dynamometer base were adjusted for each subject and noted for the second session. Before starting the recording of isokinetic muscle performance, there will be a familiarization period with the apparatus consisting of five submaximal voluntary concentric muscle contractions in the full range of standardized and preprogrammed motion (90-20°) according to the guideline procedures of the dynamometer, with a constant angular velocity of 180°/s. the isokinetic protocol will be performed with a set of 60 concentric/eccentric contractions of quadriceps. The participants will be visually and verbally encouraged throughout the test protocol to achieve maximum effort from the beginning. The muscle performance, in terms of work fatigue index, peak torque, average power, and total work of the knee extensor muscles, will be evaluated by isokinetic dynamometry in accordance with the guidelines of the equipment manufacturer (Biodex Medical System Inc.).
Experimental protocol of TECAR therapy:
Immediately after the baseline measurement of muscle performance of each session, the participants will be received placebo or active TECAR therapy.
In this experiment, Transfer Electrode Capacitive and Resistive (TECAR) Therapy (radio frequency therapy; INDIBA, Spain) will be used. TECAR therapy is a systematic treatment for providing capacitive energy transfer (CET) and resistive energy transfer (RET). In CET mode, heat transfer is concentrated on the skin and superficial muscles, which are tissue with high electrolytes, while the RET mode focuses heat transfer on bones, tendons, joints, and deep muscles. In this study, both CET and RET modes will be applied to the participant' quadriceps for 15-20 minutes at stable frequency of 448 KHz. According to the manufacturer's guidelines for safety, the CET mode will be first implemented for 5 minutes. Then will be continued in RET mode using for the rest of the treatment. Participants will be asked to lie down comfortably, and treatment will be beginning.
The intensity of the current will be set at the level of comfort between 0%-100%, averaging about 40%. TECAR therapy will be applied by a physical therapist for all participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Tecar | Active comparator | Device: Active TecarTransfer Electrode Capacitive and Resistive (TECAR) Therapy (radio frequency therapy; INDIBA, Spain) will be used. In CET mode, heat transfer is concentrated on the skin and superficial muscles, which are tissue with high electrolytes, while the RET mode focuses heat transfer on bones, tendons, joints, and deep muscles. In this study, both CET and RET modes will be applied to the participant' quadriceps for 15-20 minutes at stable frequency of 448 KHz. According to the manufacturer's guidelines for safety, the CET mode will be first implemented for 5 minutes. Then will be continued in RET mode using for the rest of the treatment. Participants will be asked to lie down comfortably, and treatment will be beginning. The intensity of the current will be set at the level of comfort between 0%-100%, averaging about 40%. TECAR therapy will be applied by a physical therapist for all participants. |
| Placebo Tecar | Placebo comparator | Device: Placebo Tecarthe same procedure as in active Tecar but the device not provide any radio frequency |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged between 23 and 35 years.
- body mass index of 20 to 25 kg/cm2
- classified as irregularly active or active, who performed physical activity with a frequency of at least five times a week, totaling a minimum of 150 min per week, according to International Physical Activity Questionnaire (IPAQ)-Short Version and reports by participants were included.
Key exclusion criteria (4 listed)
- Those with previous musculoskeletal injury to the quadriceps femoris
- Participants with hypersensitivity
- A history of arthritis, injury, or surgery on the knee or hip
- Participants that will be had a metal insert in the area requiring therapy were the excluded.
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 |
|---|---|---|
| Active TecarActive Tecar | Device | Active Tecar |
| Placebo TecarPlacebo Tecar | Device | Placebo Tecar |
Primary outcome
Peak torque of the quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer
Time frame: 5 minutes from application of treatment
The quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer
total work
Time frame: 5 minutes from application of treatment
The total work of quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer
1 secondary outcome
work fatigue index
Time frame: 5 minutes from application of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Tecar in people with TECAR Therapy and Muscle Performance, run by Cairo University at 1 site in Egypt.
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 17 Mar 2021. 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 Egypt. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak torque of the quadriceps muscles of dominant lower limb will be tested for all participants with Biodex isokinetic dynamometer (time frame: 5 minutes from application of treatment). 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 17 Mar 2021.