Ultrasound Achilles Tendon Assessment

Ultrasound Achilles Tendon Assessment After 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population

448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated at both clinical practice and also in performance. Current studies show promising results in different musculoskeletal disorders, however there no studies in the assessment of quality soft tissue in sporty population after the used of this technique.

Study Overview

• Status: Not yet recruiting
• Conditions: Ultrasonography; Achilles Tendon
• Intervention / Treatment: Device: Monopolar 448 kilohertz radiofrequency stimulation

Detailed Description

Achilles Tendon pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers and sport populations. Many factors have been proposed as the cause of pain, however there are no studies analysing possibilities of preventing Achilles Tendon injuries by using a radiofrequency stimulus.

The use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment looking for improve the quality of the tissue is still to be explored.

The hypothesis of the present project is that focus treatments on 448kilohertz capacitive resistive monopolar radiofrequency on the Achilles Tendon will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.

The stimulus will be carried out on the Achilles Tendon region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

• Study Type: Interventional
• Enrollment (Anticipated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria Cuevas Cervera; Phone Number: 661808431; Email: maaricuevass@correo.ugr.es
• Study Contact Backup: Name: Santiago Navarro Ledesma, phd; Email: snl@ugr.es

Study Locations

• Spain
  • Malaga
    • Málaga, Malaga, Spain, 29018
      • Ana Gonzalez Muñoz
      • Contact: Maria Cuevas Cervera; Phone Number: 661808431; Email: maaricuevass@correo.ugr.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age between 18-50 years
• Sporty people with at least 3 days of training per week and presenting an upper limb dominance.

Exclusion Criteria:

• Suffer from any painful Achilles Tendon condition.
• History of significant Achilles Tendon trauma, such as fracture or ultrasonography Clinically suspected partial thickness cuff tear, following the classification of Wiener and Seitz.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant Achilles Tendon	Device: Monopolar 448 kilohertz radiofrequency stimulation; 448kilohertz capacitive resistive monopolar radiofrequency will be applied on the dominant Achilles Tendon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Achilles Tendon measured by quantified elastography imaging at 3 months. time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later).	The elastography is obtained when the anatomic image on grayscale ultrasound overlaps parametric color image that expresses the rate of deformity of the tissues, soft tissues tend to develop greater deformity and tissue deformity have lower rigidity.	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later). Changes in tendinous thickness [ Time Frame: 9 months ]

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Anticipated): May 14, 2023
• Primary Completion (Anticipated): June 14, 2023
• Study Completion (Anticipated): June 12, 2024

Study Registration Dates

• First Submitted: July 17, 2022
• First Submitted That Met QC Criteria: August 10, 2022
• First Posted (Actual): August 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MCuevasCervera

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No