One Year Follow-Up Study of RelēF or ReleF Shows Durable Improvements in Pain and Function
Plantar Fasciitis Study of RelēF Shows Durable Improvements in Pain and Function
For the first time, study authors Drs. Cronkey & LaPorta offered objective criteria of the effectiveness of RelēF™ (mcRF) by documenting variation in ultrasound measurement of the thickness of the plantar fascia, and following changes over one year.
OAKLAND, California – Alpha Orthopaedics, Inc. announced today new data from a one year follow-up of the study RelēF (mcRF) for the treatment of pain associated with Plantar Fasciopathy; “The Plantar Fascia Study.” Dr. Joseph Cronkey and Dr. Guido LaPorta from Dunmore, Pennsylvania, prospectively enrolled and treated 46 subjects in this independently conducted study. Patients were treated in up to two sessions using the innovative, office-based, non-invasive RelēF Technology. In addition to the pain relief and improved function already discussed by the authors at the Eastern Orthopaedic Association (EOA) meeting in 2012, the follow-up results demonstrated a decrease in the thickness of the plantar fascia, a change that correlated well with pain relief. At one year of follow-up, all but four patients had some level of pain relief ranging from 20 to 100%.
MUSCULOSKELETAL ULTRASOUND OFFERED OBJECTIVE EVIDENCE OF EFFECTIVENESS: Recovery from plantar fasciopathy was measured using standard subjective measurements that included evaluation of pain and function utilizing the Visual Analog Scale (VAS) scoring, Roles Maudsley Score, and the Foot Function Index Questionnaire (FFIQ), pre and post treatment. In addition, objective data, i.e., ultrasound measurements of the thickness of the plantar fascia, were conducted throughout the study, since thickening had being identified as a confirming feature of the disease.
At one year follow-up, based on the study success criteria, 73% of the patients obtained good or excellent results. Likewise 72% of the patients showed a significant decrease in the thickness of the plantar fascia as evidenced by ultrasound measurements. These results were statistically significant. Moreover, 78% of the patients were satisfied with procedure outcomes, while 84% of the study participants responded that they would be willing to repeat the treatment and/or recommend to a friend. These outcomes are in line with other studies completed by other investigators and mirror the outcomes seen by physicians who have adopted the technology for their everyday practice.
RelēF Technology delivers Radiofrequency energy while cooling non-targeted tissues by conduction. The clinical benefit of the technology resides in its ability to induce tissular changes that incite the body’s wound healing response. The Alpha Orthopaedics RelēF Technology works in a totally noninvasive fashion, representing a significant advantage over alternative means that require the use of needles or surgical procedures. Dr. Terry Whipple from Orthopaedic Research of Virginia (ORV) commented: “I am very impressed by the rigorous study design, rigid adherence to clinical protocol, expert physician skill and scrupulous data gathering in the study by Drs. Cronkey and LaPorta. This study adds to the body of evidence supporting the adoption of RelēF in everyday clinical practice.”
ABOUT ALPHA ORTHOPAEDICS:
Alpha Orthopaedics, Inc. is a highly innovative U.S.-based medical device company that develops and manufactures noninvasive technologies for the treatment of musculoskeletal conditions. The company is in a pre-market mode for its RelēF Technology having completed numerous clinical evaluations and market tests in preparation for a full commercial launch. To learn more about our business and our products, please visit
www.alphaorthopaedics.com and www.relef.info
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