Morphological and Mechanical Assessment in the Achilles Tendon After Radiofrequency Stimulation in Runners (RFAchillesRun)
14 juni 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
19
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: José Daniel Gómez-Requena, PT
- Telefonnummer: 34 686305704
- E-post: danielgomezrequena@gmail.com
Studieorter
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Malaga
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Vélez-Málaga, Malaga, Spanien
- Clínica Gómez Requena
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Kontakt:
- José Daniel Gómez-Requena, PT
- Telefonnummer: 34 686305704
- E-post: danielgomezrequena@gmail.com
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-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Radiofrecuency in tendon achilles
Monopolar capacitive-resistive radiofrequency (CRMR) at 448 kHz.
Applied with the objective of hyperthermia (thermal effect).
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Achilles tendon thickness (mm) measured by B-mode ultrasound
Tidsram: 1 hour
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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.
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1 hour
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Elastography in Achilles tendon
Tidsram: 1 hour
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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.
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1 hour
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Plantar flexion strength
Tidsram: 1 hour
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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.
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1 hour
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Functionality of the lower limb
Tidsram: 1 hour
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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.
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1 hour
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 juli 2026
Primärt slutförande (Beräknad)
30 juli 2026
Avslutad studie (Beräknad)
30 juli 2026
Studieregistreringsdatum
Först inskickad
9 juni 2026
Först inskickad som uppfyllde QC-kriterierna
9 juni 2026
Första postat (Faktisk)
15 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 37-2026-H
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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