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Ultrasound Patellar Tendon Assessment

Primary Purpose

Patellofemoral Pain, Ultrasonography

Status
Not yet recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.
Placebo comparator
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patellofemoral Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clínica Ana González

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Effects of Capacitive Resistive Monopolar Radiofrequency in patellar tendon

Placebo Comparator: Placebo Monopolar Radiofrequency stimulus

Arm Description

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant patellar tendon.

To simulate the application of Monopolar Radiofrequency stimulus on the dominant patellar tendon

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 10, 2022
Last Updated
August 9, 2022
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT05497661
Brief Title
Ultrasound Patellar Tendon Assessment
Official Title
Ultrasound Patellar Tendon Assessment and Thermography After 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 14, 2022 (Anticipated)
Primary Completion Date
June 14, 2023 (Anticipated)
Study Completion Date
June 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patellofemoral Pain, Ultrasonography

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Effects of Capacitive Resistive Monopolar Radiofrequency in patellar tendon
Arm Type
Experimental
Arm Description
448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant patellar tendon.
Arm Title
Placebo Comparator: Placebo Monopolar Radiofrequency stimulus
Arm Type
Placebo Comparator
Arm Description
To simulate the application of Monopolar Radiofrequency stimulus on the dominant patellar tendon
Intervention Type
Other
Intervention Name(s)
448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.
Intervention Description
448kilohertz Capacitive Resistive Radiofrequency Stimulation on Patellar tendon in a Sporty Population.
Intervention Type
Other
Intervention Name(s)
Placebo comparator
Intervention Description
To simulate a 448kilohertz capacitive resistive monopolar radiofrequency application on the non dominant patellar tendon
Primary Outcome Measure Information:
Title
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)] ]
Description
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 Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Aguilar Garcia
Phone
0034665116747
Email
maguilar.fisioterapia@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maria Aguilar Garcia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Santiago Navarro Ledesma
Organizational Affiliation
University of Malaga
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ana González Muñoz
Organizational Affiliation
University of Malaga
Official's Role
Study Chair
Facility Information:
Facility Name
Clínica Ana González
City
Málaga
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana González Muñoz
Phone
0034665116747
Email
maguilar.fisioterapia@gmail.com
First Name & Middle Initial & Last Name & Degree
Santiago Navarro Ledesma, Phd
First Name & Middle Initial & Last Name & Degree
Daniel Aguilar Núñez, Phd student
First Name & Middle Initial & Last Name & Degree
Ana González Muñoz
First Name & Middle Initial & Last Name & Degree
María Aguilar García, Phd student

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ultrasound Patellar Tendon Assessment

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