Soft Tissue InjuriesNCT03774823
RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury
A study testing RF and PEMF and Ultrasound in people with Soft Tissue Injuries, run by Venus Concept at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Soft Tissue Injuries
- What is being tested?
- RF and PEMF and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 31 Jul 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 18Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kendall Sports Medicine and Rehabilitation Clinic
Miami, Florida, 33143
About this study
Official title: Clinical Evaluation of the Safety and Efficacy of RF and PEMF for the Treatment of Soft Tissue Injury
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.
Read the 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.
- Conditions
- Soft Tissue Injuries
- Being tested
- RF and PEMF, Ultrasound
- Keywords
- RF/PEMF, Ultrasound
- Medical subject headings
- Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF and PEMFDevice
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
UltrasoundDevice
Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area
| Study group | Role | What they receive |
|---|---|---|
| Freeze Plus | Experimental | Subjects in this arm will receive treatment using RF and PEMF Receives: Device: RF and PEMF |
| Ultrasound | Experimental | Subjects in this arm will receive treatment using ultrasound Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14
Secondary outcomes (7)
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'.
Measured: Day 14
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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: Day 21
Adverse Events
Subjects experiencing a treatment-related adverse event (AE)
Measured: Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start13 Aug 2018
- Primary completion31 Mar 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Soft Tissue InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrea Biro, Study director, Venus Concept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774823
- Sponsor's protocol ID
- CS1217
- Status last verified
- Jan 2021
- First submitted
- 26 Nov 2018
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Safety and Efficacy of RF and PEMF for the Treatment of Soft Tissue Injury
- ClinicalTrials.gov ID
- NCT03774823
- Acronym / sponsor ID
- CS1217
- Conditions
- Soft Tissue Injuries
- Keywords
- RF/PEMF, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
| Arm | Type | Receives |
|---|---|---|
| Freeze Plus | Experimental | Device: RF and PEMFSubjects in this arm will receive treatment using RF and PEMF |
| Ultrasound | Experimental | Device: UltrasoundSubjects in this arm will receive treatment using ultrasound |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RF and PEMFRF 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 | Device | Freeze Plus |
| UltrasoundUltrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area | Device | Ultrasound |
Primary outcome
Mean Reduction in BPI-SF Severity
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
7 secondary outcomes
Mean Reduction in BPI-SF Severity Score
Time frame: Day 14
Mean Reduction in BPI-SF Interference Score
Time frame: Day 14
Early Subject Satisfaction: 5-Point Likert Satisfaction Scale
Time frame: Day 8
Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale
Time frame: Day 14
Final Subject Satisfaction: 5-Point Likert Satisfaction Scale
Time frame: Day 21
Assessment of Discomfort
Time frame: Day 21
Adverse Events
Time frame: Day 21
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Biro study director
Venus Concept
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RF and PEMF and Ultrasound in people with Soft Tissue Injuries, run by Venus Concept at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Reduction in BPI-SF Severity (time frame: Day 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.