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Completed

NCT Number: NCT04273633

Ultrasound Supraspinatus Tendon Assessment After 448kilohertz 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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ana González Muñon

Málaga, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monopolar 448 kilohertz radiofrequency stimulation

Device

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

Placebo comparator

Device

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

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 18, 2020
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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