Soft Tissue Injuries
Conditions
Keywords
RF/PEMF, Ultrasound
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.
Interventions
DEVICERF 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
DEVICEUltrasound
Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area
Sponsors
Venus Concept
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant is not aware which group they will be randomized into upon entering the study
Intervention model description
One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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'. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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'. |
| Adverse Events | Day 21 | Subjects experiencing a treatment-related adverse event (AE) |
| 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. |
| 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. |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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 | 4 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Freeze Plus | Ultrasound | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 4 Participants | 8 Participants |
| Brief Pain Inventory (Short Form) BPI-SF Interference | 4.75 score on a scale STANDARD_DEVIATION 2.82 | 0.86 score on a scale STANDARD_DEVIATION 0.62 | 2.81 score on a scale STANDARD_DEVIATION 2.75 |
| Brief Pain Inventory (Short Form) BPI-SF Severity | 6.56 score on a scale STANDARD_DEVIATION 1.72 | 4.38 score on a scale STANDARD_DEVIATION 2.06 | 5.47 score on a scale STANDARD_DEVIATION 1.54 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 4 participants | 4 participants | 8 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Long Term Blood Perfusion | 19.43 Perfusion units | Standard Deviation 6.13 |
| Ultrasound | Long Term Blood Perfusion | 1.44 Perfusion units | Standard Deviation 4.24 |
Primary
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.
Time frame: Day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Mean Reduction in BPI-SF Interference Score | 2.11 score on a scale | Standard Deviation 2.96 |
| Ultrasound | Mean Reduction in BPI-SF Interference Score | 0.25 score on a scale | Standard Deviation 0.96 |
Primary
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'.
Time frame: Day 10
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Mean Reduction in BPI-SF Severity | 2.75 score on a scale | Standard Deviation 1.86 |
| Ultrasound | Mean Reduction in BPI-SF Severity | 2.44 score on a scale | Standard Deviation 1.76 |
Primary
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Short Term Blood Perfusion | 21.04 Perfusion units | Standard Deviation 2.62 |
| Ultrasound | Short Term Blood Perfusion | -0.46 Perfusion units | Standard Deviation 6.38 |
Secondary
Adverse Events
Subjects experiencing a treatment-related adverse event (AE)
Time frame: Day 21
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Freeze Plus | Adverse Events | 0 Participants |
| Ultrasound | Adverse Events | 0 Participants |
Secondary
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.
Time frame: Day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Assessment of Discomfort | 3.025 score on a scale | Standard Deviation 0.95 |
| Ultrasound | Assessment of Discomfort | 0.8 score on a scale | Standard Deviation 0.27 |
Secondary
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
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Early Subject Satisfaction: 5-Point Likert Satisfaction Scale | 3.5 score on a scale | Standard Deviation 0.6 |
| Ultrasound | Early Subject Satisfaction: 5-Point Likert Satisfaction Scale | 3.5 score on a scale | Standard Deviation 1 |
Secondary
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
Time frame: Day 21
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Final Subject Satisfaction: 5-Point Likert Satisfaction Scale | 3.4 score on a scale | Standard Deviation 0 |
| Ultrasound | Final Subject Satisfaction: 5-Point Likert Satisfaction Scale | 3.5 score on a scale | Standard Deviation 1 |
Secondary
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.
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Mean Reduction in BPI-SF Interference Score | 1.43 score on a scale | Standard Deviation 1.05 |
| Ultrasound | Mean Reduction in BPI-SF Interference Score | 0.68 score on a scale | Standard Deviation 1.01 |
Secondary
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'.
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Mean Reduction in BPI-SF Severity Score | 2.81 score on a scale | Standard Deviation 1.34 |
| Ultrasound | Mean Reduction in BPI-SF Severity Score | 0.94 score on a scale | Standard Deviation 0.94 |
Secondary
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
Time frame: Day 14
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Freeze Plus | Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale | 4 score on a scale | Standard Deviation 0 |
| Ultrasound | Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale | 3.5 score on a scale | Standard Deviation 1 |