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

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

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Injuries
• Intervention / Treatment: Device: RF and PEMF; Device: Ultrasound

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33143
      • Kendall Sports Medicine and Rehabilitation Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Able to read, understand and provide written informed consent to receive treatment.
2. Healthy, adult male or female, 18 - 75 years of age.
3. Sustained recent (within 30 days), painful unilateral mild to moderate soft tissue injury.
4. Seeking treatment for pain associated with mild to moderate soft tissue injury.
5. BMI score is greater than 18.5 and less than 29.9.
6. Able and willing to comply with the treatment and follow-up schedule and requirements.

Exclusion Criteria:

1. Pregnant, planning to become pregnant or nursing during the ocurse of the study.
2. Open wound or infection at site of soft tissue injury.
3. Evidence of severe injury, including fracture or nerve injury.
4. History of musculoskeletal disorders, including arthritis, tendonitis, bursitis, ankylosing spondylitis.
5. Moderate to severe ligament tear.
6. 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).
7. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications.
8. Having an anesthetic or corticosteroid injection within 4 weeks of study enrollment.
9. Having any active electrical implant anywhere in the body, such as a pacemaker or an internal defibrillator.
10. Having a permanent implant in the treated areas, such as metal plates and screws or an injected chemical substance.
11. History of any form of cancer or pre-malignancy in the treatment area.
12. Severe concurrent conditions, such as cardiac disorders, uncontrolled hypertension, etc.
13. Patients with history of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area.
14. History of epidermal or dermal disorders (particularly if involving collagen or microvascularity).
15. Poorly controlled endocrine disorders, such as diabetes.
16. Skin piercings in the treatment area.
17. Having a history of anxiety-depression syndromes.
18. Any condition which in the opinion of the investigator may jeopardize the patient's safe participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Freeze Plus; Subjects in this arm will receive treatment using RF and PEMF	Device: RF and PEMF; 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
Experimental: Ultrasound; Subjects in this arm will receive treatment using ultrasound	Device: Ultrasound; Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Venus Concept
• Investigators: Study Director: Andrea Biro, Venus Concept

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): March 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: November 26, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (Actual): December 13, 2018

Study Record Updates

• Last Update Posted (Actual): January 22, 2021
• Last Update Submitted That Met QC Criteria: January 4, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Ultrasound; RF/PEMF
• Additional Relevant MeSH Terms: Wounds and Injuries; Soft Tissue Injuries
• Other Study ID Numbers: CS1217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No