Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain
Primary Purpose
Chronic Shoulder Pain
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus
Sham comparator
No intervention
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Shoulder Pain
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
INTERVENTION
Placebo Monopolar Radiofrequency stimulus
No intervention group
Arm Description
448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the shoulder
To simulate the application of Monopolar Radiofrequency stimulus on the affected shoulder
To evaluate at the same time than the others groups but without being treated with 448 kilohertz Capacitive Resistive Monopolar Radiofrequency.
Outcomes
Primary Outcome Measures
Change from Baseline ultrasound imaging at 3 months
Elastography
Change from Baseline ultrasound imaging at 3 months
Tendon thickness
Secondary Outcome Measures
Electromyography
Electromyography of different shoulder muscles (deltoid, trapezius,serratus )will be measured.
Change from Baseline dynamometry at 3 months
Strength of different shoulder muscles (deltoid, trapezius,serratus )will be measured.
Algometry
Pain pressure thresholds of different shoulder muscles (deltoid, trapezius,serratus )will be measured
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.
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.
Catastrophizing Scale questionnaire
Assessment of the mechanisms by which catastrophizing impacts on pain experience.
Heart rate variability (HRV)
Measurement of Autonomic nervous system activity:
Resting HRV provides quantitative information regarding cardiac autonomic tone.
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
Full Information
NCT ID
NCT04245969
First Posted
October 15, 2019
Last Updated
January 26, 2020
Sponsor
University of Malaga
1. Study Identification
Unique Protocol Identification Number
NCT04245969
Brief Title
Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain
Official Title
Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain: A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 30, 2020 (Anticipated)
Primary Completion Date
May 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malaga
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Shoulder Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
INTERVENTION
Arm Type
Experimental
Arm Description
448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus on the shoulder
Arm Title
Placebo Monopolar Radiofrequency stimulus
Arm Type
Experimental
Arm Description
To simulate the application of Monopolar Radiofrequency stimulus on the affected shoulder
Arm Title
No intervention group
Arm Type
Experimental
Arm Description
To evaluate at the same time than the others groups but without being treated with 448 kilohertz Capacitive Resistive Monopolar Radiofrequency.
Intervention Type
Device
Intervention Name(s)
Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus
Intervention Description
448kilohertz capacitive resistive monopolar radiofrequency will be applied on the shoulder and thoracic area
Intervention Type
Other
Intervention Name(s)
Sham comparator
Intervention Description
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
Intervention Name(s)
No intervention
Intervention Description
These participants will be assessed at the same time than the rest of participants. They will not receive any kind of treatment.
Primary Outcome Measure Information:
Title
Change from Baseline ultrasound imaging at 3 months
Description
Elastography
Time Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Title
Change from Baseline ultrasound imaging at 3 months
Description
Tendon thickness
Time Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Secondary Outcome Measure Information:
Title
Electromyography
Description
Electromyography of different shoulder muscles (deltoid, trapezius,serratus )will be measured.
Time Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Title
Change from Baseline dynamometry at 3 months
Description
Strength of different shoulder muscles (deltoid, trapezius,serratus )will be measured.
Time Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Title
Algometry
Description
Pain pressure thresholds of different shoulder muscles (deltoid, trapezius,serratus )will be measured
Time Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Title
Range of movement
Description
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 Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Title
Change from baseline SPADI (Shoulder Pain And Disability Index) questionnaire at three months
Description
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 Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Title
Catastrophizing Scale questionnaire
Description
Assessment of the mechanisms by which catastrophizing impacts on pain experience.
Time Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Title
Heart rate variability (HRV)
Description
Measurement of Autonomic nervous system activity:
Resting HRV provides quantitative information regarding cardiac autonomic tone.
Time Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
Title
Autonomic Symptom Profile questionnaire (ASP)
Description
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 Frame
time (t) 1(prior to treatment), t2 (immediately after the treatment), t3 (3 months later)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of 448kilohertz Capacitive Resistive Monopolar Radiofrequency Stimulation in Chronic Shoulder Pain
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