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

9. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

19

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Spanien
    • Malaga
      • Vélez-Málaga, Malaga, Spanien

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Radiofrecuency in tendon achilles
Monopolar capacitive-resistive radiofrequency (CRMR) at 448 kHz. Applied with the objective of hyperthermia (thermal effect).
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Achilles tendon thickness (mm) measured by B-mode ultrasound
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Plantar flexion strength
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Malaga

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. juli 2026

Studieafslutning (Anslået)

30. juli 2026

Datoer for studieregistrering

Først indsendt

9. juni 2026

Først indsendt, der opfyldte QC-kriterier

9. juni 2026

Først opslået (Faktiske)

15. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 37-2026-H

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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