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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774823
Recruitment Status : Completed
First Posted : December 13, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Soft Tissue Injuries Device: RF and PEMF Device: Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
Masking: Single (Participant)
Masking Description: Participant is not aware which group they will be randomized into upon entering the study
Primary Purpose: Treatment
Official Title: Clinical Evaluation of the Safety and Efficacy of RF and PEMF for the Treatment of Soft Tissue Injury
Actual Study Start Date : August 13, 2018
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  1. Pain severity change: Brief Pain Inventory (Short Form) [ Time Frame: week 2 ]
    Change in pain severity during daily activity at Visit 4 compared to Baseline as measured by the Brief Pain Inventory (Short Form) in the RF and PEMF arm as compared to the US arm.

  2. Pain Interference: Brief Pain Inventory (Short Form) [ Time Frame: week 2 ]
    Change in pain interference during daily activity at Visit 4 compared to Baseline as measured by the Brief Pain Inventory (Short Form) in the RF and PEMF arm as compared to the US arm

  3. Short term Range of motion [ Time Frame: week 2 ]
    Change in range of motion pre- and post-treatment at Visit 4 compared to Baseline as measured by Goniometer in the RF and PEMF arm as compared to the US arm.

  4. Long term Range of motion [ Time Frame: week 4 ]
    Changes in range of motion at Visit 7 compared to Baseline as measured by Goniometer in the RF and PEMF arm as compared to the US arm.

  5. Short term blood perfusion [ Time Frame: week 3 ]
    Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 3 as measured by perfusion imaging in the RF and PEMF arm as compared to the US arm

  6. Long term blood perfusion [ Time Frame: week 2 ]
    Change in tissue blood perfusion (BP) pre- and post-treatment at Baseline, Visit 6 as measured by perfusion imaging in the RF and PEMF arm as compared to the US arm.


Secondary Outcome Measures :
  1. Change in pain severity: Brief Pain Inventory (Short Form) [ Time Frame: week 2 ]
    Change in pain severity during daily activity at Visit 6 as measured by the Brief Pain Inventory (Short Form) in the RF and PEMF arm as compared to the US arm.

  2. Change in pain interference: Brief Pain Inventory (Short Form) [ Time Frame: week 2 ]
    Change in pain interference during daily activity at Visit 6 as measured by the Brief Pain Inventory (Short Form) in the RF and PEMF arm as compared to the US arm.

  3. Range of motion [ Time Frame: week 2 ]
    Change in range of motion pre- and post-treatment at Visit 6 as measured by Goniometer in the RF and PEMF arm as compared to the US arm.

  4. Early Subject satisfaction: 5-point Likert Satisfaction scale [ Time Frame: week 2 ]

    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


  5. Midpoint Subject Satisfaction: 5-point Likert Satisfaction scale [ Time Frame: week 2 ]

    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


  6. Final Subject Satisfaction: 5-point Likert Satisfaction scale [ Time Frame: week 3 ]

    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


  7. Final blood perfusion [ Time Frame: week 3 ]
    Change in tissue blood perfusion (BP) compared to Baseline at Visit 7 as measured by perfusion imaging in the RF and PEMF arm as compared to the US arm.

  8. Assessment of discomfort [ Time Frame: week 3 ]
    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.

  9. Adverse events [ Time Frame: week 3 ]
    Subjects experiencing a treatment-related adverse event (AE)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774823


Locations
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United States, Florida
Kendall Sports Medicine and Rehabilitation Clinic
Miami, Florida, United States, 33143
Sponsors and Collaborators
Venus Concept
Investigators
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Study Director: Andrea Biro Venus Concept
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Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT03774823    
Other Study ID Numbers: CS1217
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Venus Concept:
RF/PEMF
Ultrasound
Additional relevant MeSH terms:
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Wounds and Injuries
Soft Tissue Injuries