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

NCT03774823 | Completed Results FDA Device

• 1 other identifier: CS1217
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Soft Tissue Injuries

Keywords

RF/PEMF; Ultrasound

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• 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

• Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale

  Day 14

• Final Subject Satisfaction: 5-Point Likert Satisfaction Scale

  Day 21

Study Arms (2)

Freeze Plus

EXPERIMENTAL

Subjects in this arm will receive treatment using RF and PEMF

Device: RF and PEMF

Ultrasound

EXPERIMENTAL

Subjects in this arm will receive treatment using ultrasound

Device: Ultrasound

Interventions

RF and PEMF DEVICE

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

Freeze Plus

Ultrasound DEVICE

Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area

Ultrasound

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Kendall Sports Medicine and Rehabilitation Clinic

Miami, Florida, 33143, United States

Location

MeSH Terms

Conditions

Soft Tissue Injuries

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Director, Clinical Affairs
• Organization: Venus Concept Ltd.

mgronski@venusconcept.com

888-907-0115

Study Officials

• Andrea Biro

  Venus Concept

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant is not aware which group they will be randomized into upon entering the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: December 13, 2018
• Study Start: August 13, 2018
• Primary Completion: March 31, 2019
• Study Completion: July 31, 2019
• Last Updated: January 22, 2021
• Results First Posted: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)