Ultrasound Achilles Tendon Assessment

Ultrasonography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05498987
• Other study ID #: MCuevasCervera
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 14, 2023
• Est. completion date: June 12, 2024

Study information

• Verified date: April 2023
• Source: Universidad de Granada
• Contact: Maria Cuevas Cervera
• Phone: 661808431
• Email: maaricuevass[@]correo.ugr.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 28
• Est. completion date: June 12, 2024
• Est. primary completion date: June 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Achilles Tendon
• Ultrasonography

Intervention

Device:
• Monopolar 448 kilohertz radiofrequency stimulation
448kilohertz capacitive resistive monopolar radiofrequency will be applied on the dominant Achilles Tendon

Locations

Country	Name	City	State
Spain	Ana Gonzalez Muñoz	Málaga	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ]