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

Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain: A Randomised Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Shoulder Pain
• Intervention / Treatment: Device: Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus; Other: Sham comparator; Other: No intervention

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)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: INTERVENTION; 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the shoulder	Device: Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus; 448kilohertz capacitive resistive monopolar radiofrequency will be applied on the shoulder and thoracic area
EXPERIMENTAL: Placebo Monopolar Radiofrequency stimulus; To simulate the application of Monopolar Radiofrequency stimulus on the affected shoulder	Other: 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.
EXPERIMENTAL: No intervention group; To evaluate at the same time than the others groups but without being treated with 448 kilohertz Capacitive Resistive Monopolar Radiofrequency.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline ultrasound imaging at 3 months	Elastography	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Change from Baseline ultrasound imaging at 3 months	Tendon thickness	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electromyography	Electromyography of different shoulder muscles (deltoid, trapezius,serratus )will be measured.	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Change from Baseline dynamometry at 3 months	Strength of different shoulder muscles (deltoid, trapezius,serratus )will be measured.	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Algometry	Pain pressure thresholds of different shoulder muscles (deltoid, trapezius,serratus )will be measured	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Range of movement	Measurement of mobility in different planes: Active shoulder flexion and abduction will be measured with the patient seated, in the scapular plane and relative to the thorax. In addition, active external and internal rotation will be measured in neutral (shoulder in adduction), 30°, 60° and 90° of abducted position.	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at three months	The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities.	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Catastrophizing Scale questionnaire	Assessment of the mechanisms by which catastrophizing impacts on pain experience.	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Heart rate variability (HRV)	Measurement of Autonomic nervous system activity: Resting HRV provides quantitative information regarding cardiac autonomic tone.	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Autonomic Symptom Profile questionnaire (ASP)	Measurement of Autonomic nervous system activity: The Autonomic Symptom Profile (ASP) is a validated self-report questionnaire that comprehensively assesses autonomic symptoms across 11 subscales and yields a composite autonomic symptom score	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)

Collaborators and Investigators

• Sponsor: University of Malaga

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 30, 2020
• Primary Completion (ANTICIPATED): May 30, 2020
• Study Completion (ANTICIPATED): December 31, 2020

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: January 26, 2020
• First Posted (ACTUAL): January 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2020
• Last Update Submitted That Met QC Criteria: January 26, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: CRMRFSP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No