Strain of Gastrocnemius Muscle (Diagnosis)NCT04325750
Energy Transfer Therapy in Treatment of Medial Gastrocnemius
A study testing TECAR Therapy in people with Strain of Gastrocnemius Muscle (Diagnosis) and Diathermy Plate Burn, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
Trial summary
This study develops the effects of Capacitive and Resistive Energy Transfer Therapy (TECAR) on medial gastrocnemius using thermographic cameras, algometry and lunge tests, in a pre-post study with basketball players using a control group to which placebo is applied. Read more about this study
- Who is it for?
- Ages 16 to 39 years, men only
- Conditions the study is for
- Strain of Gastrocnemius Muscle (Diagnosis), Diathermy Plate Burn, Thermography
- What is being tested?
- TECAR Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2018to 28 Aug 2020
- 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 16 to 39 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male players
- Semi-professional players who are currently active
- Not have suffered a lower limb injury in the last 6 months before the study
- Not having suffered a rupture of the triceps surae
- Contain a latent trigger point in the medial gastrocnemius
Who cannot join
- Players suffering from any disease that could alter the study or be contradictory
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Capacitive and Resistive Energy Transfer Therapy in Pre and Post-treatment Medial Gastrocnemius in National Level Basketball Players
This study develops the effects of Capacitive and Resistive Energy Transfer Therapy (TECAR) on medial gastrocnemius using thermographic cameras, algometry and lunge tests, in a pre-post study with basketball players using a control group to which placebo is applied. (simulated technique) and an intervention group to which the technique is performed. The main objective of the study is to establish whether the TECAR produces physiological and mechanical changes in the subjects that improve muscle recovery.
- Conditions
- Strain of Gastrocnemius Muscle (Diagnosis), Diathermy Plate Burn, Thermography, Sports Physical Therapy
- Being tested
- TECAR Therapy, Placebo
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECAR TherapyProcedure or surgery
The intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current.
PlaceboOther
simulated TECAR Therapy (machine off)
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | The simulated mode technique is applied (machine off) Receives: Other: Placebo |
| TECAR THERAPY | Experimental | The intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current. Receives: Procedure: TECAR Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
Visual analogue scale (VAS) of pain
Measured: 30 minutes
Secondary outcomes (2)
Back flexion
LUNGE Test
Measured: 30 minutes
Thermographic evaluation
Ymiko Wifi Digital Weather Station with FLIR E60 camera and interpreted with FLIR tools software.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Jun 2018
- Primary completion28 Aug 2020
- Study completion28 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strain of Gastrocnemius Muscle (Diagnosis)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Barrios Pitarque, Fundación Universidad Católica de Valencia San Vicente Mártir
- Investigators
- Carlos Barrios, PhD, Study director, Universidad Católica de Valencia San Vicente Mártir
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04325750
- Sponsor's protocol ID
- UCV2017-2018-40
- Status last verified
- Sep 2020
- First submitted
- 23 Mar 2020
- Last updated
- 29 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Capacitive and Resistive Energy Transfer Therapy in Pre and Post-treatment Medial Gastrocnemius in National Level Basketball Players
- ClinicalTrials.gov ID
- NCT04325750
- Acronym / sponsor ID
- UCV2017-2018-40
- Conditions
- Strain of Gastrocnemius Muscle (Diagnosis), Diathermy Plate Burn, Thermography, Sports Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 28 Aug 2020 (actual)
- Study completion
- 28 Aug 2020 (actual)
- First posted
- 30 Mar 2020 (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.
This study develops the effects of Capacitive and Resistive Energy Transfer Therapy (TECAR) on medial gastrocnemius using thermographic cameras, algometry and lunge tests, in a pre-post study with basketball players using a control group to which placebo is applied. (simulated technique) and an intervention group to which the technique is performed. The main objective of the study is to establish whether the TECAR produces physiological and mechanical changes in the subjects that improve muscle recovery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: PlaceboThe simulated mode technique is applied (machine off) |
| TECAR THERAPY | Experimental | Procedure: TECAR TherapyThe intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current. |
Who may qualify
- Ages
- 16 to 39 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male players
- Semi-professional players who are currently active
- Not have suffered a lower limb injury in the last 6 months before the study
- Not having suffered a rupture of the triceps surae
- Contain a latent trigger point in the medial gastrocnemius
Key exclusion criteria (1 listed)
- Players suffering from any disease that could alter the study or be contradictory
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 |
|---|---|---|
| TECAR TherapyThe intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current. | Procedure or surgery | TECAR THERAPY |
| Placebosimulated TECAR Therapy (machine off) | Other | Control |
Primary outcome
Pain intensity
Time frame: 30 minutes
Visual analogue scale (VAS) of pain
2 secondary outcomes
Back flexion
Time frame: 30 minutes
Thermographic evaluation
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2020.
- Individual participant dataSharing planned: No
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.
Carlos Barrios, PhD study director
Universidad Católica de Valencia San Vicente Mártir
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECAR Therapy in people with Strain of Gastrocnemius Muscle (Diagnosis) and Diathermy Plate Burn, run by Fundación Universidad Católica de Valencia San Vicente Mártir 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 29 Sep 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pain intensity (time frame: 30 minutes). 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 29 Sep 2020.