Clinical trial NCT04273633: Ultrasound Supraspinatus Tendon Assessment After 448kilohertz Radiofrequency Stimulation in a Sporty Population.
Official title: Ultrasound Supraspinatus Tendon Assessment After 448kilohertz Capacitive Resistive Radiofrequency Stimulation in a Sporty Population.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasonography
Shoulder
Lead sponsor: University of Malaga
Sponsor class: OTHER
First posted: 2020-02-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in supraspinatus tendon measured by quantified elastography imaging at 3 months
timeFrame: Time Frame: time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)]
Secondary outcomes:
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Ana González Muñon
Study officials:
References:
citation: 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.