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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
University of Malaga
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Shoulder Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

    First Posted
    October 15, 2019
    Last Updated
    January 26, 2020
    Sponsor
    University of Malaga
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    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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