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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Freeze Plus | Experimental | Subjects in this arm will receive treatment using RF and PEMF |
|
| Ultrasound | Experimental | Subjects in this arm will receive treatment using ultrasound |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF and PEMF | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | Day 10 |
| 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. | Day 10 |
| 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. | Day 8 |
| 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. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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'. | Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Biro | Venus Concept | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kendall Sports Medicine and Rehabilitation Clinic | Miami | Florida | 33143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subjects seeking treatment for pain associated with mild to moderate soft tissue injury.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Ultrasound |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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'. | Posted | Mean | Standard Deviation | score on a scale | Day 10 |
|
Adverse data were collected for up to 21 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Affairs | Venus Concept Ltd. | 888-907-0115 | mgronski@venusconcept.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2018 | Oct 15, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017695 | Soft Tissue Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
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Participant is not aware which group they will be randomized into upon entering the study
| Ultrasound | Device | 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 | 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. | Day 14 |
| 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 | Day 8 |
| 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 | Day 14 |
| 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 | Day 21 |
| 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. | Day 21 |
| Adverse Events | Subjects experiencing a treatment-related adverse event (AE) | Day 21 |
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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Brief Pain Inventory (Short Form) | The Brief Pain Inventory - Short Form (BPI-SF) is a self-administered questionnaire made up of the response to 2 components: a) BPI-SF Severity which is the severity of a patient's pain and b) BPI-SF Interference which is the impact of this pain on daily functioning. The patient is asked to rate severity and interference on a 10-point scale where 0 represents 'No pain/No interference' and 10 represents 'Pain/Interference as bad as you can imagine'. | Mean | Standard Deviation | score on a scale |
|
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
|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 10 |
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| 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. | One subject in the Freeze Plus arm and one subject in the Ultrasound arm did not have blood perfusion measured at visit 3. | Posted | Mean | Standard Deviation | Perfusion units | Day 8 |
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| 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. | One subject in the Freeze Plus arm and one subject in the Ultrasound arm did not have blood perfusion measured at visit 6. | Posted | Mean | Standard Deviation | Perfusion units | Day 14 |
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| 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'. | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
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|
|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
|
|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Day 8 |
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|
|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Day 14 |
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|
| 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 | Posted | Mean | Standard Deviation | score on a scale | Day 21 |
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|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Day 21 |
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| Secondary | Adverse Events | Subjects experiencing a treatment-related adverse event (AE) | Posted | Count of Participants | Participants | Day 21 |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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 | 0 | 4 | 0 | 4 | 0 | 4 |
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