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

Primary Purpose

Plantar Fascia; Contracture

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Radiofrecuency
Sponsored by
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Plantar Fascia; Contracture

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Clinica Ana GonzalezRecruiting
  • Clinica Ana GonzalezRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiofrequency stimulus on the dominant PLANTAR FASCIOPATHY

Arm Description

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant Plantar fasciopathy

Outcomes

Primary Outcome Measures

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
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
June 26, 2022
Last Updated
July 12, 2022
Sponsor
University of Malaga
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1. Study Identification

Unique Protocol Identification Number
NCT05460117
Brief Title
Elastography and Thermography Plantar Fasciopathy Assessment After Radiofrequency Stimulation in a Sporty Population
Official Title
Elastography and Thermography Plantar Fasciopathy Assessment After Radiofrequency Stimulation in a Sporty Population
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
September 12, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plantar Fascia; Contracture

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Radiofrequency stimulus on the dominant PLANTAR FASCIOPATHY
Arm Type
Experimental
Arm Description
448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant Plantar fasciopathy
Intervention Type
Device
Intervention Name(s)
Radiofrecuency
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
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
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Clinica Ana Gonzalez
City
Malaga
State/Province
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Gonzalez Muñoz
Phone
653 50 37 92
Email
daguilarn.tic@gmail.com
Facility Name
Clinica Ana Gonzalez
City
Malaga
State/Province
Málaga
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Gonzalez Muñoz
Phone
653 50 37 92
Email
clinicanagonzalez@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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