Ultrasound Supraspinatus Tendon Assessment After 448kilohertz Radiofrequency Stimulation in a Sporty Population.

Sponsor
University of Malaga (Other)
Overall Status
Completed
CT.gov ID
NCT04273633
Collaborator
(none)
38
1
2
10.2
3.7

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: Monopolar 448 kilohertz radiofrequency stimulation
  • Device: Placebo comparator
N/A

Detailed Description

Shoulder 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 shoulder 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.

The stimulus will be carried out on the shoulder region (suprascapular, axillar, subscapular, long thoracic or pectoralis nerves) and the thoracic region. All interventions will be developed by the same examiner, who is a physiotherapist with 6 years of clinical experience.

Study Design

Study Type:
Interventional
Actual Enrollment :
38 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Ultrasound Supraspinatus Tendon Assessment After 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.
Actual Study Start Date :
Feb 1, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Dec 6, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: INTERVENTION

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant shoulder

Device: Monopolar 448 kilohertz radiofrequency stimulation
448kilohertz capacitive resistive monopolar radiofrequency will be applied on the dominant shoulder

Placebo Comparator: Placebo Monopolar Radiofrequency stimulus

To simulate the application of Monopolar Radiofrequency stimulus on the dominant shoulder

Device: Placebo comparator
To simulate a 448kilohertz capacitive resistive monopolar radiofrequency application on the dominant shoulder

Outcome Measures

Primary Outcome Measures

  1. Change from Baseline in supraspinatus tendon measured by quantified elastography imaging at 3 months [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.

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 Ana González Muñon Málaga Spain

Sponsors and Collaborators

  • University of Malaga

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
SANTIAGO NAVARRO LEDESMA, UNIVERSITY PROFESSOR, University of Malaga
ClinicalTrials.gov Identifier:
NCT04273633
Other Study ID Numbers:
  • CRMRSPORT
First Posted:
Feb 18, 2020
Last Update Posted:
Dec 10, 2020
Last Verified:
Dec 1, 2020
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

Study Results

No Results Posted as of Dec 10, 2020