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

NCT04273633 | Completed DMC

• 1 other identifier: CRMRSPORT
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Ultrasonography; Shoulder

Outcome Measures

Primary Outcomes (1)

• 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)]

Study Arms (2)

INTERVENTION

EXPERIMENTAL

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant shoulder

Device: Monopolar 448 kilohertz radiofrequency stimulation

Placebo Monopolar Radiofrequency stimulus

PLACEBO COMPARATOR

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

Device: Placebo comparator

Interventions

Monopolar 448 kilohertz radiofrequency stimulation DEVICE

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

INTERVENTION

Placebo comparator DEVICE

To simulate a 448kilohertz capacitive resistive monopolar radiofrequency application on the dominant shoulder

Placebo Monopolar Radiofrequency stimulus

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 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

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Ana González Muñon

Málaga, Spain

Location

Related Publications (1)

• 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.

  PMID: 33691576 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UNIVERSITY PROFESSOR

Study Record Dates

• First Submitted: February 11, 2020
• First Posted: February 18, 2020
• Study Start: February 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 6, 2020
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

ES (1)