Clinical Studies and White Papers

An Open-Label Pilot Study Investigating Noninvasive High-Frequency Peripheral Nerve Fiber Stimulation in Chronic Pain

D.A. Hegarty, B. Bretherton. Pain Management and Neuromodulation, Mater Private Hospital, Cork; Department of Anesthesiology, School of Medicine, University College, Cork, Ireland; School of Biomedical Sciences, Faculty of Biological Sciences, University of Leeds, Leeds; Pain Management Department, Leeds Teaching Hospitals NHS Trust, Leeds, UK

Post-operative pain treatment following total knee replacement surgery using BioWavePENS

T. Wanich, J. Gelber, R. Windsor, S. Rodeo. A randomized controlled pilot study to determine average maximum intensity settings, safety, and initial efficacy in terms of pain reduction, increased range of motion, and reduced pain medications, for a percutaneous neuromodulation pain therapy device (“BioWavePENS®”) following post-operative treatments for total knee replacement procedures.

Podium Presentation:
Eastern Orthopaedic Association 39th Annual Meeting, October 22-25, 2008, Ritz-Carlton, Lake Las Vegas, Henderson, Nevada

Poster Presentation:
American Academy of Orthopaedic Surgeons 2009 Annual Meeting, February 25-28, 2009, Las Vegas, Nevada

Treatment of chronic pain from osteoarthritis of the knee using BioWavePENS

Brian J. Cole, MD, MBA; Richard Kang, MD, MS; Paul B. Lewis, MD, MS; Adam Kramer, ATC; Jennifer K. Hayden, RN, MSN; Randomized Single-blinded Controlled Clinical Trial of a BiowavePENS device (Percutaneous Electrical Nerve Stimulation) versus Sham PENS treatment for the Osteoarthritic Knee. Orthopedics, June 2007, Volume 30, Number 6.

Treatment of pain from acute sports injuries using BioWavePRO

S. Panchal, J. Pergolizzi. White Paper on use of a neuromodulation pain therapy device (“BioWavePRO”) to treat acute sports injuries on New York Giants football players. 600 treatments on 80 players from June 2003 – December 2005. Unpublished manuscript, 2006.

Treatment of joint pain using BioWaveHOME

W. Coren. A clinical study of the efficacy of the BioWave home device for reducing pain and increasing range of motion over 24 hours following a 20-minute treatment of shoulder, knee, hip, and extremity pain. Unpublished manuscript, 2003.

Evaluation of optimal signal frequency and efficacy of BioWave

S. Diwan, H.C. Hemmings, R.F. Eliazo, S. Panchal. Symptomatic treatment of chronic low back pain: determination of optimal signal frequency and preliminary efficacy of a targeted noninvasive electronic pain control device. Anesth. Analg. Abstracts 96 S-1-S: 293, 2003.

Randomized, Double-Blinded, Comparative Crossover Trial Comparing Biowave vs TENS

S. Diwan MD, H. Hemmings MD, PhD, S. Panchal MD, Summary of a Randomized, Double-Blinded, Comparative Crossover Trial of the Safety and Efficacy of a Non-Invasive Targeted Electronic Pain Control Device (“Biowave System”) Versus Transcutaneous Electrical Nerve Stimulation (TENS) for the Symptomatic Treatment of Chronic Low Back Pain; March 2006.

Long Term Use of BioWaveHOME for the Treatment of Chronic Pain in Veterans

L. Kleinwaks, M. Rogers, D. McGurl.Long Term Use of BiowaveHOME High Frequency Neurostimulation for the Treatment of Chronic Pain in Veterans Following Successful BiowavePRO Neurostimulation Therapy in Veterans Administration Hospitals. White Paper, October 2017.

DISCLAIMER: This White Paper contains additional clinical information regarding BioWave and is provided for informational purposes only. Musculoskeletal Clinical Regulatory Advisors, LLC (MCRA), an independent organization, prepared this White Paper; the methodology used by MCRA in preparing the White Paper is set forth in the document, including on pages 2-4. Preparation of the White Paper was funded by BioWave Corporation. The White Paper neither constitutes nor implies an endorsement by the United States Government, the U.S. Department of Veteran Affairs, the Veteran’s Health Administration or any other governmental entity or organization. Consult your physician or health provider about whether treatment with a BioWave device is right for you.

Neuromodulation Pain Therapy Treatment

R. Yacoub. Neuromodulation pain therapy. ADVANCE for Physical Therapy and Rehab Medicine 23(13): 22-24, 2012.

Significantly Reduced Pain and Improved Function Following Short-Term Use of the BioWaveHOME High Frequency Neurostimulation System for Conservative Pain Management

Lindsay Kleinwaks, Ph.D., Senior Associate, Regulatory Affairs Dave McGurl, Director, Regulatory Affairs. Following two weeks of BioWaveHOME use, four hundred sixty three (463) subjects provided responses via returned surveys. The BioWaveHOME device provided subjects with statistically and clinically significant reductions in pain, with an average reduction in pain score of 3 points.

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