A double blind, randomized control study on the efficacy of Electro Pressure Regeneration Therapy (EPRT) devices for acute ankle sprain treatment
- Location: Department of Orthopedic Surgery, Mount Sinai Medical Center, New York, New York
Objective: Ankle injuries, typically ankle inversion injuries, are the most common orthopedic condition treated in clinical practice.
Among military personnel, these injuries result in significant lost duty time and impact military readiness. In addition, these injuries may lead to prolonged ankle pain, chronic ankle laxity, and potential re-injury. In the battlefield, they may be a detriment to survival.
Research has demonstrated the efficacy of electronic devices in reducing edema and pain of sprained ankles. The Electro Pressure Regeneration Therapy (EPRT) is a non-invasive, ultra-low electrical current device that stimulates regeneration of injured tissue, reduces inflammation, and enhances an immune response in the treatment of pain, wound healing, and cellular regeneration. The ultimate goal of this research is to identify portable, non-pharmaceutical therapies for ankle sprains to reduce the lost duty time of military personnel.
Research Design: This double-blind, randomized sham-controlled study (n=40) evaluates the efficacy of standard care plus active or sham EPRT on pain intensity, swelling, quality of life, and function for patients with acute grade 2-3 ankle injuries.
Methodology: Outpatients who present to Mount Sinai Hospital in New York City and who meet the eligibility criteria and consent will undergo pre and post test assessments of pain intensity, swelling, quality of life and function. After the initial post treatment assessment, participants will be followed by telephone to monitor swelling and pain on days 1, 3, 7, and a final clinical visit between days 10 to 12, when they will be evaluated for quality of life and function. Medication use will be self reported (diary) daily until the final assessment.
Outcome: This research study was initiated by FAIM and has been transferred to another institution for completion.