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

Not Applicable

Completed

Conditions: Soft Tissue Injuries

Interventions: Device: Ultrasound
Device: RF and PEMF

Registration Number: NCT03774823

Lead Sponsor: Venus Concept

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 10

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	Ultrasound	Subjects in this arm will receive treatment using ultrasound
Freeze Plus	RF and PEMF	Subjects in this arm will receive treatment using RF and PEMF

Primary Outcome Measures

Name	Time	Method
Short Term Blood Perfusion	Day 8	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.
Mean Reduction in BPI-SF Interference Score	Day 10	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.
Long Term Blood Perfusion	Day 14	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.
Mean Reduction in BPI-SF Severity	Day 10	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'.

Secondary Outcome Measures

Name	Time	Method
Final Subject Satisfaction: 5-Point Likert Satisfaction Scale	Day 21	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
Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale	Day 14	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
Assessment of Discomfort	Day 21	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.
Adverse Events	Day 21	Subjects experiencing a treatment-related adverse event (AE)
Mean Reduction in BPI-SF Severity Score	Day 14	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'.
Mean Reduction in BPI-SF Interference Score	Day 14	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.
Early Subject Satisfaction: 5-Point Likert Satisfaction Scale	Day 8	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