RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury

Study Overview
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Brief Summary
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The study will investigate whether the impact of PEMF and RF therapies is safe and efficacious for the treatment of pain associated with soft tissue injuries as compared to treatment with ultrasound, and to show the effects of PEMF and RF therapies on range of motion and blood flow associated with soft tissue injuries as compared to ultrasound therapy.

Detailed Description
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This is a randomized, controlled study of the safety and efficacy of a radiofrequency (RF) and pulsed electromagnetic fields (PEMF) device compared to ultrasound (US) for the treatment of pain associated with soft tissue injuries, and to show the comparative effects on blood flow (BF) and range of motion (ROM). Total expected duration of the clinical study is approximately 6 months (enrollment period of 4 months and a follow-up period of 3 weeks) while individual participation will take three weeks.

Official Title
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Clinical Evaluation of the Safety and Efficacy of RF and PEMF for the Treatment of Soft Tissue Injury

Conditions
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Soft Tissue Injuries

Intervention / Treatment
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* Device: RF and PEMF
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to read, understand and provide written informed consent to receive treatment. Healthy, adult male or female, 18 - 75 years of age. Sustained recent (within 30 days), painful unilateral mild to moderate soft tissue injury. Seeking treatment for pain associated with mild to moderate soft tissue injury. BMI score is greater than 18.5 and less than 29.9. Able and willing to comply with the treatment and follow-up schedule and requirements. Exclusion Criteria: Pregnant, planning to become pregnant or nursing during the ocurse of the study. Open wound or infection at site of soft tissue injury. Evidence of severe injury, including fracture or nerve injury. History of musculoskeletal disorders, including arthritis, tendonitis, bursitis, ankylosing spondylitis. Moderate to severe ligament tear. Having a known anti-coagulative or thromboembolic condition or taking anticoagulation medications one week prior to and during the treatment course (to allow inclusion, temporary cessation of anticoagulant use as per the subject's physician discretion is permitted). History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications. Having an anesthetic or corticosteroid injection within 4 weeks of study enrollment. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator. Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance. History of any form of cancer or pre-malignancy in the treatment area. Severe concurrent conditions, such as cardiac disorders, uncontrolled hypertension, etc. Patients with history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity). Poorly controlled endocrine disorders, such as diabetes. Skin piercings in the treatment area. Having a history of anxiety-depression syndromes. Any condition which in the opinion of the investigator may jeopardize the patient's safe participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Freeze Plus<br>Subjects in this arm will receive treatment using RF and PEMF | Device: RF and PEMF<br>* RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment<br>|
| Experimental: Ultrasound<br>Subjects in this arm will receive treatment using ultrasound | Device: Ultrasound<br>* Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Reduction in BPI-SF Severity | Reduction in pain severity during daily activity at Visit 4 compared to Baseline as measured by the Brief Pain Inventory (Short Form) - Severity. BPI-SF assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'. | Day 10 | 
| Mean Reduction in BPI-SF Interference Score | Reduction in pain interference during daily activity at Visit 4 compared to Baseline as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items. | Day 10 | 
| Short Term Blood Perfusion | Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 3 as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion. | Day 8 | 
| Long Term Blood Perfusion | Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 6 as measured by perfusion imaging as measured by perfusion imaging, measured in perfusion units (PU) where a positive value indicates an increase in blood perfusion and a negative value indicate a decrease in blood perfusion. | Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Reduction in BPI-SF Severity Score | Reduction in pain severity during daily activity at Visit 6 as measured by the BPI-SF Severity score. BPI-SF Severity score assesses pain at its 'worst', 'least', 'average', and 'now' (current pain) and is rated on a scale of 0-10, where 0 represents 'No pain' and 10 represents 'Pain as bad as you can imagine'. | Day 14 | 
| Mean Reduction in BPI-SF Interference Score | Reduction in pain interference during daily activity at Visit 6 as measured by the BPI-SF Interference score. BPI-SF Interference score measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. The 0-10 scale is also used for pain interference, where 0 represents 'does not interfere' and 10 represents 'completely interferes'. BPI pain interference is typically scored as the mean of the seven interference items. | Day 14 | 
| Early Subject Satisfaction: 5-Point Likert Satisfaction Scale | Subjects' assessment of satisfaction with the treatment at Visit 4 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as: 4 being very satisfied 3 being satisfied 2 having no opinion 1 being unsatisfied 0 being very unsatisfied | Day 8 | 
| Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale | Subjects' assessment of satisfaction with the treatment at Visit 6 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as: 4 being very satisfied 3 being satisfied 2 having no opinion 1 being unsatisfied 0 being very unsatisfied | Day 14 | 
| Final Subject Satisfaction: 5-Point Likert Satisfaction Scale | Subjects' assessment of satisfaction with the treatment at Visit 7 as measured with a scale, called a 5-point Likert Subject Satisfaction Scale. The scale parameters are defined as: 4 being very satisfied 3 being satisfied 2 having no opinion 1 being unsatisfied 0 being very unsatisfied | Day 21 | 
| Assessment of Discomfort | Subject's assessment of discomfort and pain with treatment as measured by a 10 cm visual analog scale (VAS). A line which ranges from 10 being the worst pain ever to 0 being no pain at all. | Day 21 | 
| Adverse Events | Subjects experiencing a treatment-related adverse event (AE) | Day 21 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RF/PEMF, Ultrasound