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

• Sponsor: Venus Concept (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03774823
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arms: 2
• Actual Duration (Months): 11.6
• Patients Per Site Per Month: 0.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Soft Tissue Injuries	Device: RF and PEMF; Device: Ultrasound	N/A

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
• 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 ultrasoundOne 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: Aug 13, 2018
• Actual Primary Completion Date: Mar 31, 2019
• Actual Study Completion Date: Jul 31, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Mean Reduction in BPI-SF Severity [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'.

2. Mean Reduction in BPI-SF Interference Score [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.

3. Short Term Blood Perfusion [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.

4. Long Term Blood Perfusion [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.

Secondary Outcome Measures

1. Mean Reduction in BPI-SF Severity Score [Day 14]

   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'.

2. Mean Reduction in BPI-SF Interference Score [Day 14]

   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.

3. Early Subject Satisfaction: 5-Point Likert Satisfaction Scale [Day 8]

   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

4. Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale [Day 14]

   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

5. Final Subject Satisfaction: 5-Point Likert Satisfaction Scale [Day 21]

   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

6. Assessment of Discomfort [Day 21]

   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.

7. Adverse Events [Day 21]

   Subjects experiencing a treatment-related adverse event (AE)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kendall Sports Medicine and Rehabilitation Clinic	Miami	Florida	United States	33143

Sponsors and Collaborators

• Venus Concept

Investigators

• Study Director: Andrea Biro, Venus Concept

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 15, 2018

More Information

Publications

None provided.

• Responsible Party: Venus Concept
• ClinicalTrials.gov Identifier: NCT03774823
• Other Study ID Numbers: CS1217
• First Posted: Dec 13, 2018
• Last Update Posted: Jan 22, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Wounds and Injuries; Soft Tissue Injuries

Study Results

Participant Flow

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Period Title: Overall Study
STARTED	5	5
COMPLETED	4	4
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Freeze Plus	Ultrasound	Total
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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	Total of all reporting groups
Overall Participants	4	4	8
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	4 100%	4 100%	8 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	1 25%	0 0%	1 12.5%
Male	3 75%	4 100%	7 87.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 75%	4 100%	7 87.5%
Not Hispanic or Latino	1 25%	0 0%	1 12.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	4 100%	4 100%	8 100%
Brief Pain Inventory (Short Form) (score on a scale) [Mean (Standard Deviation) ]
BPI-SF Severity	6.56 (1.72)	4.38 (2.06)	5.47 (1.54)
BPI-SF Interference	4.75 (2.82)	0.86 (0.62)	2.81 (2.75)

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	4	4
Mean (Standard Deviation) [score on a scale]	2.75 (1.86)	2.44 (1.76)

2. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	4	4
Mean (Standard Deviation) [score on a scale]	2.11 (2.96)	0.25 (0.96)

3. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

One subject in the Freeze Plus arm and one subject in the Ultrasound arm did not have blood perfusion measured at visit 3.

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	3	3
Mean (Standard Deviation) [Perfusion units]	21.04 (2.62)	-0.46 (6.38)

4. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

One subject in the Freeze Plus arm and one subject in the Ultrasound arm did not have blood perfusion measured at visit 6.

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	3	3
Mean (Standard Deviation) [Perfusion units]	19.43 (6.13)	1.44 (4.24)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	4	4
Mean (Standard Deviation) [score on a scale]	2.81 (1.34)	0.94 (0.94)

6. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	4	4
Mean (Standard Deviation) [score on a scale]	1.43 (1.05)	0.68 (1.01)

7. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	4	4
Mean (Standard Deviation) [score on a scale]	3.5 (0.6)	3.5 (1)

8. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	4	4
Mean (Standard Deviation) [score on a scale]	4 (0)	3.5 (1)

9. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	4	4
Mean (Standard Deviation) [score on a scale]	3.4 (0)	3.5 (1)

10. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	4	4
Mean (Standard Deviation) [score on a scale]	3.025 (.95)	0.8 (0.27)

11. Secondary Outcome

Title	Adverse Events
Description	Subjects experiencing a treatment-related adverse event (AE)
Time Frame	Day 21

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Freeze Plus	Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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	Subjects in this arm will receive treatment using ultrasound 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
Measure Participants	4	4
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Adverse data were collected for up to 21 days.
Arm/Group Title	Freeze Plus		Ultrasound
Arm/Group Description	Subjects in this arm will receive treatment using RF and PEMF 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		Subjects in this arm will receive treatment using ultrasound 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
All Cause Mortality
	Freeze Plus		Ultrasound
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Serious Adverse Events
	Freeze Plus		Ultrasound
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)
Other (Not Including Serious) Adverse Events
	Freeze Plus		Ultrasound
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/4 (0%)		0/4 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.