NCT05498987

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

August 12, 2022

Completed
9 months until next milestone

Study Start

First participant enrolled

May 14, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 14, 2023

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2024

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

July 17, 2022

Last Update Submit

April 24, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline in Achilles Tendon measured by quantified elastography imaging at 3 months. 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 (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later). Changes in tendinous thickness [ Time Frame: 9 months ]

Study Arms (1)

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant Achilles Tendon

EXPERIMENTAL

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant Achilles Tendon

Device: Monopolar 448 kilohertz radiofrequency stimulation

Interventions

448kilohertz capacitive resistive monopolar radiofrequency will be applied on the dominant Achilles Tendon

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant Achilles Tendon

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18-50 years
  • Sporty people with at least 3 days of training per week and presenting an upper limb dominance.

You may not qualify if:

  • Suffer from any painful Achilles Tendon condition.
  • History of significant Achilles Tendon trauma, such as fracture or ultrasonography Clinically suspected partial thickness cuff tear, following the classification of Wiener and Seitz.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana Gonzalez Muñoz

Málaga, Malaga, 29018, Spain

Location

Central Study Contacts

Maria Cuevas Cervera

CONTACT

Santiago Navarro Ledesma, phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 17, 2022

First Posted

August 12, 2022

Study Start

May 14, 2023

Primary Completion

June 14, 2023

Study Completion

June 12, 2024

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations