Back to resultsRF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury
Primary Purpose
Soft Tissue Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RF and PEMF
Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Soft Tissue Injuries focused on measuring RF/PEMF, Ultrasound
Eligibility Criteria
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.
Sites / Locations
- Kendall Sports Medicine and Rehabilitation Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Freeze Plus
Ultrasound
Arm Description
Subjects in this arm will receive treatment using RF and PEMF
Subjects in this arm will receive treatment using ultrasound
Outcomes
Primary Outcome Measures
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'.
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.
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.
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.
Secondary Outcome Measures
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'.
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.
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
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
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
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.
Adverse Events
Subjects experiencing a treatment-related adverse event (AE)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03774823
Brief Title
RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury
Official Title
Clinical Evaluation of the Safety and Efficacy of RF and PEMF for the Treatment of Soft Tissue Injury
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
March 31, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Injuries
Keywords
RF/PEMF, Ultrasound
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
Masking
Participant
Masking Description
Participant is not aware which group they will be randomized into upon entering the study
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Freeze Plus
Arm Type
Experimental
Arm Description
Subjects in this arm will receive treatment using RF and PEMF
Arm Title
Ultrasound
Arm Type
Experimental
Arm Description
Subjects in this arm will receive treatment using ultrasound
Intervention Type
Device
Intervention Name(s)
RF and PEMF
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
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 Measure Information:
Title
Mean Reduction in BPI-SF Severity
Description
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'.
Time Frame
Day 10
Title
Mean Reduction in BPI-SF Interference Score
Description
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.
Time Frame
Day 10
Title
Short Term Blood Perfusion
Description
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.
Time Frame
Day 8
Title
Long Term Blood Perfusion
Description
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.
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Mean Reduction in BPI-SF Severity Score
Description
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'.
Time Frame
Day 14
Title
Mean Reduction in BPI-SF Interference Score
Description
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.
Time Frame
Day 14
Title
Early Subject Satisfaction: 5-Point Likert Satisfaction Scale
Description
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
Time Frame
Day 8
Title
Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale
Description
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
Time Frame
Day 14
Title
Final Subject Satisfaction: 5-Point Likert Satisfaction Scale
Description
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
Time Frame
Day 21
Title
Assessment of Discomfort
Description
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.
Time Frame
Day 21
Title
Adverse Events
Description
Subjects experiencing a treatment-related adverse event (AE)
Time Frame
Day 21
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Biro
Organizational Affiliation
Venus Concept
Official's Role
Study Director
Facility Information:
Facility Name
Kendall Sports Medicine and Rehabilitation Clinic
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury
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