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

Not Applicable

Completed

• Conditions: Shoulder; Ultrasonography
• Interventions: Device: Monopolar 448 kilohertz radiofrequency stimulation; Device: Placebo comparator

• Registration Number: NCT04273633
• Lead Sponsor: University of Malaga

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.

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 Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-02-11
• Study First Submitted QC: 2020-02-13
• Study First Posted: 2020-02-18
• Primary Completion: 2020-11-30
• Status Verified: 2020-12
• Study Completion: 2020-12-06
• Last Update Submitted: 2020-12-08
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INTERVENTION	Monopolar 448 kilohertz radiofrequency stimulation	448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant shoulder
Placebo Monopolar Radiofrequency stimulus	Placebo comparator	To simulate the application of Monopolar Radiofrequency stimulus on the dominant shoulder

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ana González Muñon; 🇪🇸 Málaga, Spain