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

14. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Detaljert 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. 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.

Studietype

Intervensjonell

Registrering (Antatt)

19

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Malaga
      • Vélez-Málaga, Malaga, Spania

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske 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 or pregnancy
  • Contraindication for radiofrecuency treatment.
  • Athletes with visual, auditory, or any other impairment that may affect their cognitive ability to understand the test.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2026

Primær fullføring (Antatt)

30. juli 2026

Studiet fullført (Antatt)

30. juli 2026

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

9. juni 2026

Først lagt ut (Faktiske)

15. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

17. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

14. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 37-2026-H

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

UBESLUTTE

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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