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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05497661
Other study ID # UGranadaPatellarTendon
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 14, 2022
Est. completion date June 12, 2024

Study information

Verified date August 2022
Source Universidad de Granada
Contact Maria Aguilar Garcia
Phone 0034665116747
Email maguilar.fisioterapia@gmail.com
Is FDA regulated No
Health authority
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:

Patellar tendon injuries is is one of the most common musculoskeletal disorders, presenting a high prevalence in sport populations. Many factors have been proposed as the cause of pain and dysfunction, however there are no studies analysing possibilities of preventing patellar 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 patellar 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 patellar 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 65 Years
Eligibility Inclusion Criteria: - Age between 18-65 years. - Sporty people with at least 3 days of training per week Exclusion Criteria: - Suffer from knee pain. - Sedentary people

Study Design


Intervention

Other:
448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.
448kilohertz Capacitive Resistive Radiofrequency Stimulation on Patellar tendon in a Sporty Population.
Placebo comparator
To simulate a 448kilohertz capacitive resistive monopolar radiofrequency application on the non dominant patellar tendon

Locations

Country Name City State
Spain Clínica Ana González Málaga

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 patellar tendon measured by quantified elastography imaging at 3 months [ Time Frame: Time Frame: 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 Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
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