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

Sponsor
University of Malaga (Other)
Overall Status
Recruiting
CT.gov ID
NCT05460117
Collaborator
(none)
28
2
1
6
14
2.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Radiofrecuency
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Elastography and Thermography Plantar Fasciopathy Assessment After Radiofrequency Stimulation in a Sporty Population
Actual Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Sep 12, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Radiofrequency stimulus on the dominant PLANTAR FASCIOPATHY

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

Device: Radiofrecuency
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.

Outcome Measures

Primary Outcome Measures

  1. 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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinica Ana Gonzalez Malaga Málaga Spain
2 Clinica Ana Gonzalez Malaga Málaga Spain

Sponsors and Collaborators

  • University of Malaga

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daniel Aguilar Nunez, Clinical Professor, University of Malaga, University of Malaga
ClinicalTrials.gov Identifier:
NCT05460117
Other Study ID Numbers:
  • DAN15
First Posted:
Jul 15, 2022
Last Update Posted:
Jul 15, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2022