Clinical trial NCT03774823: RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury
Official title: Clinical Evaluation of the Safety and Efficacy of RF and PEMF for the Treatment of Soft Tissue Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Soft Tissue Injuries
Keywords: RF/PEMF
Ultrasound
Lead sponsor: Venus Concept
Sponsor class: INDUSTRY
First posted: 2018-12-13
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group receives treatment with RF and PEMF while the second group receives treatment with ultrasound
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Reduction in BPI-SF Severity
timeFrame: Day 10
measure: Mean Reduction in BPI-SF Interference Score
timeFrame: Day 10
measure: Short Term Blood Perfusion
timeFrame: Day 8
measure: Long Term Blood Perfusion
timeFrame: Day 14
Secondary outcomes:
measure: Mean Reduction in BPI-SF Severity Score
timeFrame: Day 14
measure: Mean Reduction in BPI-SF Interference Score
timeFrame: Day 14
measure: Early Subject Satisfaction: 5-Point Likert Satisfaction Scale
timeFrame: Day 8
measure: Midpoint Subject Satisfaction: 5-Point Likert Satisfaction Scale
timeFrame: Day 14
measure: Final Subject Satisfaction: 5-Point Likert Satisfaction Scale
timeFrame: Day 21
measure: Assessment of Discomfort
timeFrame: Day 21
measure: Adverse Events
timeFrame: Day 21
Other outcomes:
Locations:
city: Miami
country: United States
facility: Kendall Sports Medicine and Rehabilitation Clinic
state: Florida
Study officials:
affiliation: Venus Concept
name: Andrea Biro
role: STUDY_DIRECTOR
References: