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

Chronic Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04245969
• Other study ID #: CRMRFSP
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: January 2020
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Shoulder Pain
• Shoulder Pain

Intervention

Device:
• Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus
448kilohertz capacitive resistive monopolar radiofrequency will be applied on the shoulder and thoracic area

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.
• No intervention
These participants will be assessed at the same time than the rest of participants. They will not receive any kind of treatment.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline ultrasound imaging at 3 months	Elastography	time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)