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

NCT ID: NCT04273633

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2020-12-06

Brief Summary

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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

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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.

Conditions

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Ultrasonography Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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INTERVENTION

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the dominant shoulder

Group Type EXPERIMENTAL

Monopolar 448 kilohertz radiofrequency stimulation

Intervention Type DEVICE

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

Placebo Monopolar Radiofrequency stimulus

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

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DEVICE

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

Interventions

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Monopolar 448 kilohertz radiofrequency stimulation

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

Intervention Type DEVICE

Placebo comparator

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Malaga

OTHER

Sponsor Role lead

Responsible Party

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SANTIAGO NAVARRO LEDESMA

UNIVERSITY PROFESSOR

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ana González Muñon

Málaga, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33691576 (View on PubMed)

Other Identifiers

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CRMRSPORT

Identifier Type: -

Identifier Source: org_study_id