Trial Outcomes & Findings for RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury (NCT NCT03774823)

Results Overview

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'.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Day 10

Results posted on

2021-01-22

Participant Flow

Participant milestones

Participant milestones
Measure	Freeze Plus 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	Ultrasound 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
Overall Study STARTED	5	5
Overall Study COMPLETED	4	4
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Freeze Plus 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	Ultrasound 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
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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 n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	8 participants n=5 Participants
Brief Pain Inventory (Short Form) BPI-SF Severity	6.56 score on a scale STANDARD_DEVIATION 1.72 • n=5 Participants	4.38 score on a scale STANDARD_DEVIATION 2.06 • n=7 Participants	5.47 score on a scale STANDARD_DEVIATION 1.54 • n=5 Participants
Brief Pain Inventory (Short Form) BPI-SF Interference	4.75 score on a scale STANDARD_DEVIATION 2.82 • n=5 Participants	0.86 score on a scale STANDARD_DEVIATION 0.62 • n=7 Participants	2.81 score on a scale STANDARD_DEVIATION 2.75 • n=5 Participants

PRIMARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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
Mean Reduction in BPI-SF Severity	2.75 score on a scale Standard Deviation 1.86	2.44 score on a scale Standard Deviation 1.76

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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
Mean Reduction in BPI-SF Interference Score	2.11 score on a scale Standard Deviation 2.96	0.25 score on a scale Standard Deviation 0.96

PRIMARY outcome

Timeframe: Day 8

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

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.

Outcome measures

Outcome measures
Measure	Freeze Plus n=3 Participants 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	Ultrasound n=3 Participants 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
Short Term Blood Perfusion	21.04 Perfusion units Standard Deviation 2.62	-0.46 Perfusion units Standard Deviation 6.38

PRIMARY outcome

Timeframe: Day 14

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

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.

Outcome measures

Outcome measures
Measure	Freeze Plus n=3 Participants 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	Ultrasound n=3 Participants 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
Long Term Blood Perfusion	19.43 Perfusion units Standard Deviation 6.13	1.44 Perfusion units Standard Deviation 4.24

SECONDARY outcome

Timeframe: 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'.

Outcome measures

Outcome measures
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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
Mean Reduction in BPI-SF Severity Score	2.81 score on a scale Standard Deviation 1.34	0.94 score on a scale Standard Deviation 0.94

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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
Mean Reduction in BPI-SF Interference Score	1.43 score on a scale Standard Deviation 1.05	0.68 score on a scale Standard Deviation 1.01

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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
Early Subject Satisfaction: 5-Point Likert Satisfaction Scale	3.5 score on a scale Standard Deviation 0.6	3.5 score on a scale Standard Deviation 1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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
Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale	4 score on a scale Standard Deviation 0	3.5 score on a scale Standard Deviation 1

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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
Final Subject Satisfaction: 5-Point Likert Satisfaction Scale	3.4 score on a scale Standard Deviation 0	3.5 score on a scale Standard Deviation 1

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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
Assessment of Discomfort	3.025 score on a scale Standard Deviation .95	0.8 score on a scale Standard Deviation 0.27

SECONDARY outcome

Timeframe: Day 21

Subjects experiencing a treatment-related adverse event (AE)

Outcome measures

Outcome measures
Measure	Freeze Plus n=4 Participants 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	Ultrasound n=4 Participants 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
Adverse Events	0 Participants	0 Participants

Adverse Events

Freeze Plus

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Clinical Affairs

Venus Concept Ltd.

Phone: 888-907-0115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place