Elastography and Thermography Plantar Fasciopathy Assessment After Radiofrequency Stimulation in a Sporty Population

July 12, 2022 updated by: Daniel Aguilar Nunez, University of Malaga
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

Recruiting

Intervention / Treatment

Detailed Description

Plantar Fasciopathy 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 foot 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 shoulder will produce better outcomes in terms of ultrasound assessment measured by quantified elastography, and this will decreased the possibilities of get injured.

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Málaga
      • Malaga, Málaga, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 shoulder condition.
  • History of significant shoulder trauma, such as fracture or ultrasonography
  • Clinically suspected partial thickness cuff tear, following the classification of Wiener and Seitz.
  • Recent shoulder dislocation in the past two years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Radiofrequency stimulus on the dominant PLANTAR FASCIOPATHY
448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant Plantar fasciopathy
he 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in plantar fasciopathy 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)]. Changes in tendinous thickness
Time Frame: 9 months
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Anticipated)

September 12, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

June 26, 2022

First Submitted That Met QC Criteria

July 12, 2022

First Posted (Actual)

July 15, 2022

Study Record Updates

Last Update Posted (Actual)

July 15, 2022

Last Update Submitted That Met QC Criteria

July 12, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • DAN15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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