Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain

University of Malaga

Status: Unknown

Conditions: Chronic Shoulder Pain

Treatments: Device: Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus; Other: No intervention; Other: Sham comparator

Study type: Interventional

Funder types: Other

Identifiers

NCT04245969

CRMRFSP

Details and patient eligibility

About

448kilohertz capacitive resistive monopolar radiofrequency is a novel technique in physiotherapy and its usefulness and clinical relevance is still to be investigated. Current studies show promising results in different musculoskeletal disorders, however further studies with proper designs and conclusive findings are necessary.

Full description

Shoulder pain is is one of the most common musculoskeletal disorders, presenting a high prevalence in primary care centers. Many factors have been proposed as the cause of pain, however it is still controversial and the same regarding the best treatment option.

Treatments throw different techniques have been investigated, showing a variety of results in terms of pain and sensitivity. However, the use of 448kilohertz capacitive resistive monopolar radiofrequency as the focus of the treatment is 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, strength, pain, sensitivity and range of movement, when compared to traditional methods used like manual therapy and/or exercise.

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.

The outcome measures will be electromyography and dynamometry to measure strength and muscular activity. The movements required to the patient will be shoulder flexion, abduction, adduction, and extension.

To quantify sensitivity, pain pressure thresholds will be measured throw an algometer placed on the coracoid process, on the lateral area of the shoulder (two centimeters below the acromion and on the acromioclavicular joint).

To measure the range of movement, a goniometer will be used for both glenohumeral and scapular rotations.

To measure quality of life and psychological factors several questionnaires will be asked (Pain catastrophizing scale, Pain vigilance and awareness questionnaire, Self-efficacy, SPADI, Tampa Scale-11, McGill)

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• To suffer from shoulder pain more than three months.
• Men or women aged between 18 to 65 years;
• Unilateral pain located in the anterior and/or lateral shoulder region;
• 2 out of 3 positive clinical tests (Hawkins-Kennedy; Jobe; Neer);
• Pain with normal activity ≥ 4/10 on a visual analogue scale;
• Nontraumatic onset of shoulder pain.

Exclusion criteria

• History of significant shoulder trauma, such as fracture or ultrasonography-clinically suspected full thickness cuff tear, following the classification of Wiener and Seitz
• Recent shoulder dislocation in the past two years
• Systemic illnesses such as rheumatoid arthritis
• Adhesive capsulitis of the shoulder
• Shoulder pain originating from the neck or if there was a neurological impairment, osteoporosis, hemophilia and/or malignancies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 3 patient groups

INTERVENTION

Experimental group

Description:

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the shoulder

Treatment:

Device: Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus

Placebo Monopolar Radiofrequency stimulus

Experimental group

Description:

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

Treatment:

Other: Sham comparator

No intervention group

Experimental group

Description:

To evaluate at the same time than the others groups but without being treated with 448 kilohertz Capacitive Resistive Monopolar Radiofrequency.

Treatment:

Other: No intervention