Achilles Tendon InjuryRFAchillesRunNCT07648199
Morphological and Mechanical Assessment in the Achilles Tendon After Radiofrequency Stimulation in Runners
A study testing 448 kHz capacitive resistive monopolar radiofrequency in people with Achilles Tendon Injury and Achilles Tendon, run by University of Malaga at 1 site in Spain.
Trial summary
448 kHz capacitive-resistive monopolar radiofrequency is an emerging physiotherapy technique whose usefulness and clinical relevance still need to be investigated. This study is a pre-post quasi-experimental study in which several variables will be measured before and immediately after 448 kHz capacitive resistive… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Achilles Tendon Injury, Achilles Tendon
- What is being tested?
- 448 kHz capacitive resistive monopolar radiofrequency
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2026to 30 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-65
- Runners with at least one year of regular practice.
- Must not have suffered any ligament, bone, tendon, or muscle injury in the lower limb or lumbar region during the last year.
Who cannot join
- History of lower limb surgery, rheumatic or neuromuscular diseases or pregnancy
- Contraindication for radiofrecuency treatment.
- Athletes with visual, auditory, or any other impairment that may affect their cognitive ability to understand the test.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Clínica Gómez Requena
Vélez-Málaga, Malaga
José Daniel Gómez-Requena, PT, 34 686305704, danielgomezrequena@gmail.com
About this study
Official title: Morphological and Mechanical Changes in the Achilles Tendon After the Application of INDIBA® Therapy in Healthy Runners: A Pre-post Quasi-experimental Study
448 kHz capacitive-resistive monopolar radiofrequency is an emerging physiotherapy technique whose usefulness and clinical relevance still need to be investigated. This study is a pre-post quasi-experimental study in which several variables will be measured before and immediately after 448 kHz capacitive resistive monopolar radiofrequency. It aims to analyze the morphological and mechanical changes in the Achilles tendon following the intervention in healthy runners.
Read the detailed description
The Achilles tendon is fundamental to running biomechanics, and its performance directly affects athletic performance and injury prevention. 448 kHz capacitive resistive monopolar radiofrequency has demonstrated effects on vascularization, recovery, and elasticity of musculoskeletal tissues. However, there are no studies that comprehensively evaluate the morphological, mechanical, and functional changes in the Achilles tendón in healthy runners after the application of this technique. The investigators expect the intervention to induce short-term morphological and mechanical changes in the Achilles tendon, providing further insight into the potential of this technique as a preventive tool.
- Conditions
- Achilles Tendon Injury, Achilles Tendon
- Being tested
- 448 kHz capacitive resistive monopolar radiofrequency
- Keywords
- Achilles tendon, Radiofrecuency, Physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
448 kHz capacitive resistive monopolar radiofrequencyDevice
The procedure will consist of a 20-minute radiofrequency session on the Achilles tendon, applying 10 minutes in capacitive mode and 10 minutes in resistive mode. The device has a maximum peak power of 200 W and 450 V. Both modes will be administered as a hyperthermia dose, adjusted according to the patient's subjective perception of heat, with a target of 8/10. The application will be performed longitudinally on the Achilles tendon, from proximal to distal and from distal to proximal, measuring the variables before and after the procedure. In resistive mode, continuous wave will be used, and the return electrode will be a plate placed under the patient's abdomen. The entire procedure will be carried out following the manufacturer's instructions.
| Study group | Role | What they receive |
|---|---|---|
| Radiofrecuency in tendon achilles | Experimental | Monopolar capacitive-resistive radiofrequency (CRMR) at 448 kHz. Applied with the objective of hyperthermia (thermal effect). Receives: Device: 448 kHz capacitive resistive monopolar radiofrequency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achilles tendon thickness (mm) measured by B-mode ultrasound
The Achilles tendon will be assessed with the participant in a prone position, legs extended and feet resting over the edge of the examination couch. Ultrasound images will be acquired using a linear transducer in the long axis of the tendon, at the level of the medial malleolus, in order to reduce bone-related artefacts. B-mode ultrasound will be used for the evaluation.
Measured: 1 hour
Elastography in Achilles tendon
Tendon stiffness and elasticity were assessed using compression elastography. Color-coded elastographic maps and quantitative tissue deformation values were obtained following standardized procedures previously described in the literature. Measurements were performed at the same procedure used for measuring tendon thickness.
Measured: 1 hour
Secondary outcomes (2)
Plantar flexion strength
It will be assessed using an electronic isometric dynamometer, recording the maximum force generated during a voluntary plantar flexion contraction against fixed resistance, maintaining a standardized ankle position and performing several attempts to obtain a reliable value.
Measured: 1 hour
Functionality of the lower limb
It will be evaluated using the Multijump Rebound Test, a validated test that analyzes the capacity for repeated jumping and the efficiency of the stretch-shortening cycle, allowing the functional changes to be related to the morphological and mechanical properties of the muscle-tendon system.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Achilles Tendon InjuryStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Trinidad-Fernández, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07648199
- Sponsor's protocol ID
- 37-2026-H
- Acronym
- RFAchillesRun
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Initially, individual participant data are not planned to be shared. However, data sharing may be considered if a formal collaboration agreement is proposed by another research group working on the same topic, provided that the request is scientifically justified and ethically appropriate. In such cases, all necessary protocols and safeguards will be implemented to ensure data anonymisation, confidentiality, and compliance with applicable data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphological and Mechanical Changes in the Achilles Tendon After the Application of INDIBA® Therapy in Healthy Runners: A Pre-post Quasi-experimental Study
- ClinicalTrials.gov ID
- NCT07648199
- Acronym / sponsor ID
- RFAchillesRun / 37-2026-H
- Conditions
- Achilles Tendon Injury, Achilles Tendon
- Keywords
- Achilles tendon, Radiofrecuency, Physiotherapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 15 Jun 2026 (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.
448 kHz capacitive-resistive monopolar radiofrequency is an emerging physiotherapy technique whose usefulness and clinical relevance still need to be investigated. This study is a pre-post quasi-experimental study in which several variables will be measured before and immediately after 448 kHz capacitive resistive monopolar radiofrequency. It aims to analyze the morphological and mechanical changes in the Achilles tendon following the intervention in healthy runners.
Detailed description
The Achilles tendon is fundamental to running biomechanics, and its performance directly affects athletic performance and injury prevention. 448 kHz capacitive resistive monopolar radiofrequency has demonstrated effects on vascularization, recovery, and elasticity of musculoskeletal tissues. However, there are no studies that comprehensively evaluate the morphological, mechanical, and functional changes in the Achilles tendón in healthy runners after the application of this technique. The investigators expect the intervention to induce short-term morphological and mechanical changes in the Achilles tendon, providing further insight into the potential of this technique as a preventive tool.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiofrecuency in tendon achilles | Experimental | Device: 448 kHz capacitive resistive monopolar radiofrequencyMonopolar capacitive-resistive radiofrequency (CRMR) at 448 kHz. Applied with the objective of hyperthermia (thermal effect). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18-65
- Runners with at least one year of regular practice.
- Must not have suffered any ligament, bone, tendon, or muscle injury in the lower limb or lumbar region during the last year.
Key exclusion criteria (3 listed)
- History of lower limb surgery, rheumatic or neuromuscular diseases or pregnancy
- Contraindication for radiofrecuency treatment.
- Athletes with visual, auditory, or any other impairment that may affect their cognitive ability to understand the test.
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 |
|---|---|---|
| 448 kHz capacitive resistive monopolar radiofrequencyThe procedure will consist of a 20-minute radiofrequency session on the Achilles tendon, applying 10 minutes in capacitive mode and 10 minutes in resistive mode. The device has a maximum peak power of 200 W and 450 V. Both modes will be administered as a hyperthermia dose, adjusted according to the patient's subjective perception of heat, with a target of 8/10. The application will be performed longitudinally on the Achilles tendon, from proximal to distal and from distal to proximal, measuring the variables before and after the procedure. In resistive mode, continuous wave will be used, and the return electrode will be a plate placed under the patient's abdomen. The entire procedure will be carried out following the manufacturer's instructions. | Device | Radiofrecuency in tendon achilles |
Primary outcome
Achilles tendon thickness (mm) measured by B-mode ultrasound
Time frame: 1 hour
The Achilles tendon will be assessed with the participant in a prone position, legs extended and feet resting over the edge of the examination couch. Ultrasound images will be acquired using a linear transducer in the long axis of the tendon, at the level of the medial malleolus, in order to reduce bone-related artefacts. B-mode ultrasound will be used for the evaluation.
Elastography in Achilles tendon
Time frame: 1 hour
Tendon stiffness and elasticity were assessed using compression elastography. Color-coded elastographic maps and quantitative tissue deformation values were obtained following standardized procedures previously described in the literature. Measurements were performed at the same procedure used for measuring tendon thickness.
2 secondary outcomes
Plantar flexion strength
Time frame: 1 hour
Functionality of the lower limb
Time frame: 1 hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Individual participant dataSharing planned: Undecided. Initially, individual participant data are not planned to be shared. However, data sharing may be considered if a formal collaboration agreement is proposed by another research group working on the same topic, provided that the request is scientifically justified and ethically appropriate. In such cases, all necessary protocols and safeguards will be implemented to ensure data anonymisation, confidentiality, and compliance with applicable data protection regulations.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 448 kHz capacitive resistive monopolar radiofrequency in people with Achilles Tendon Injury and Achilles Tendon, run by University of Malaga 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 3 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: opening soon, as of the sponsor's last update on 17 Jun 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact José Daniel Gómez-Requena, PT (34 686305704, danielgomezrequena@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achilles tendon thickness (mm) measured by B-mode ultrasound (time frame: 1 hour). 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 Jun 2026.