Morphological and Mechanical Assessment in the Achilles Tendon After Radiofrequency Stimulation in Runners (RFAchillesRun)

June 9, 2026 updated by: Manuel Trinidad-Fernández, University of Malaga

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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. We 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 Type

Interventional

Enrollment (Estimated)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Malaga
      • Vélez-Málaga, Malaga, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • History of lower limb surgery, rheumatic or neuromuscular diseases, pregnancy, or any other contraindication for radiofrecuency treatment.
  • Individuals with visual, auditory, or any other impairment that may affect their cognitive ability to understand the test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrecuency in tendon achilles
Monopolar capacitive-resistive radiofrequency (CRMR) at 448 kHz. Applied with the objective of hyperthermia (thermal effect).
Device: 448 kHz capacitive resistive monopolar radiofrequency
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour
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.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plantar flexion strength
Time Frame: 1 hour
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.
1 hour
Functionality of the lower limb
Time Frame: 1 hour
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

June 9, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 15, 2026

Study Record Updates

Last Update Posted (Actual)

June 15, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 37-2026-H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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