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

NCT ID: NCT04245969

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-30
• Study Completion Date: 2020-12-31

Brief Summary

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.

Detailed 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)

Conditions

Chronic Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

INTERVENTION

448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the shoulder

Group Type: EXPERIMENTAL

Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus

Intervention Type: DEVICE

448kilohertz capacitive resistive monopolar radiofrequency will be applied on the shoulder and thoracic area

Placebo Monopolar Radiofrequency stimulus

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

Group Type: EXPERIMENTAL

Sham comparator

Intervention Type: OTHER

A simulation of 448kilohertz capacitive resistive monopolar radiofrequency will be carried out to make believe the patient to be treated through this equipment.

No intervention group

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

Group Type: EXPERIMENTAL

No intervention

Intervention Type: OTHER

These participants will be assessed at the same time than the rest of participants. They will not receive any kind of treatment.

Interventions

Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus

448kilohertz capacitive resistive monopolar radiofrequency will be applied on the shoulder and thoracic area

Intervention Type: DEVICE

Sham comparator

A simulation of 448kilohertz capacitive resistive monopolar radiofrequency will be carried out to make believe the patient to be treated through this equipment.

Intervention Type: OTHER

No intervention

These participants will be assessed at the same time than the rest of participants. They will not receive any kind of treatment.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malaga

OTHER

Sponsor Role: lead

Responsible Party

SANTIAGO NAVARRO LEDESMA

UNIVERSITY PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

CRMRFSP

Identifier Type: -

Identifier Source: org_study_id