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

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

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: Completed
• Conditions: Ultrasonography; Shoulder
• Intervention / Treatment: Device: Monopolar 448 kilohertz radiofrequency stimulation; Device: Placebo comparator

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 Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Málaga, Spain
    • Ana González Muñon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 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

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in supraspinatus tendon measured by quantified elastography imaging at 3 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.	Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)]

Collaborators and Investigators

• Sponsor: University of Malaga

Publications and helpful links

General Publications

• Navarro-Ledesma S, Gonzalez-Munoz A. Short-term effects of 448 kilohertz radiofrequency stimulation on supraspinatus tendon elasticity measured by quantitative ultrasound elastography in professional badminton players: a double-blinded randomized clinical trial. Int J Hyperthermia. 2021;38(1):421-427. doi: 10.1080/02656736.2021.1896790.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 6, 2020

Study Registration Dates

• First Submitted: February 11, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: CRMRSPORT

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