Status:
COMPLETED
RF/PEMF Versus Ultrasound for the Treatment of Soft Tissue Injury
Lead Sponsor:
Venus Concept
Conditions:
Soft Tissue Injuries
Eligibility:
All Genders
18-75 years
Phase:
NA
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, ...
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 associa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
- 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.
Key Trial Info
Start Date :
August 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03774823
Start Date
August 13 2018
End Date
July 31 2019
Last Update
January 22 2021
Active Locations (1)
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1
Kendall Sports Medicine and Rehabilitation Clinic
Miami, Florida, United States, 33143