Clinical Evaluation of the Safety and Efficacy of RF and PEMF for the Treatment of Soft Tissue Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Venus Concept
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Short Term Blood Perfusion
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
Participant is not aware which group they will be randomized into upon entering the study
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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.
Outcomes
Primary Outcomes
Short Term Blood Perfusion
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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 Outcomes
- Final Subject Satisfaction: 5-Point Likert Satisfaction Scale(Day 21)
- Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale(Day 14)
- Assessment of Discomfort(Day 21)
- Adverse Events(Day 21)
- Mean Reduction in BPI-SF Severity Score(Day 14)
- Mean Reduction in BPI-SF Interference Score(Day 14)
- Early Subject Satisfaction: 5-Point Likert Satisfaction Scale(Day 8)