Prospective, Multicenter, Randomized, Double-Blinded, Partial Crossover Study to Assess the Safety and Efficacy of the Novel Neuromodulation System in the Treatment of Patients With Chronic Pain of Peripheral Nerve Origin

Neuromodulation : Journal of the International Neuromodulation Society
Timothy DeerNagy Mekhail

Abstract

Currently available central nervous system treatment strategies are often insufficient in management of peripheral neuropathic pain, prompting a resurgence of neuromodulation focused on peripheral pain. A new peripheral nerve stimulation device was investigated in a prospective, randomized, double blind, crossover study, looking specifically at efficacy and safety, with Food and Drug Administration oversight. Prospective, multicenter, randomized, double-blind, partial crossover study to assess safety and efficacy. After IRB approval, patients were enrolled, implanted, and then followed for three months to assess efficacy and one year for safety based on Food and Drug Administration guidance. One hundred forty-seven patients were consented and screened for the study. Thirty-five did not meet inclusion or exclusion criteria. Ninety-four patients were implanted and then randomized to the treatment (45) or the Control group (49). The primary efficacy endpoint, three months after randomization to treatment, demonstrated that patients receiving active stimulation achieved a statistically significantly higher response rate of 38% vs. the 10% rate found in the Control group (p = 0.0048). Improvement in pain was statistically significan...Continue Reading

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Citations

Sep 28, 2016·Current Pain and Headache Reports·Krishnan ChakravarthyKayode Williams
Oct 20, 2017·Current Urology Reports·Juan M Guzman-Negron, Howard B Goldman
Dec 15, 2018·Neuromodulation : Journal of the International Neuromodulation Society·Guilherme S PiedadePhilipp J Slotty
May 20, 2020·Current Opinion in Urology·F M J Martens, K-D Sievert
Apr 7, 2020·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Brendan Langford, William D Mauck
Aug 18, 2020·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Vafi SalmasiMatthew Pingree
Aug 22, 2020·Current Pain and Headache Reports·Jay KarriAlaa Abd-Elsayed
Jan 14, 2020·Neuromodulation : Journal of the International Neuromodulation Society·John Taylor Mansfield, Mehul J Desai
Sep 9, 2020·Anesthesiology·Brian M Ilfeld, John J Finneran
Oct 12, 2018·Pain Research and Treatment·Raghavendra Nayak, Ratan K Banik
Jun 4, 2019·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Michael A FishmanRobert Levy
May 29, 2020·Current Urology Reports·Annah Vollstedt, Jason Gilleran
Jan 4, 2017·Neuromodulation : Journal of the International Neuromodulation Society·Timothy R DeerNagy Mekhail
Jan 27, 2019·Brain Sciences·Timothy R DeerKrishnan Chakravarthy
Aug 18, 2020·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Timothy R DeerNagy Mekhail
Jan 27, 2019·Nature Reviews. Neurology·Andres M LozanoJoachim K Krauss
May 2, 2019·Therapeutic Advances in Urology·Serge P Marinkovic
Jan 4, 2017·Neuromodulation : Journal of the International Neuromodulation Society·Timothy R DeerNagy Mekhail
Sep 13, 2017·Laryngoscope Investigative Otolaryngology·Ronald SahyouniHarrison W Lin
Jun 2, 2017·Journal of Neurophysiology·Arthur Prochazka
Oct 25, 2020·Neuromodulation : Journal of the International Neuromodulation Society·Mark A ChmielaMichael Stanton-Hicks
Dec 10, 2020·Pain Management·Shane M RegnierKrishnan V Chakravarthy
Nov 23, 2020·Pain Practice : the Official Journal of World Institute of Pain·Nafisseh S WarnerWilliam D Mauck
Jul 28, 2016·Current Opinion in Anaesthesiology·Lance A RoyRichard Rauck
Mar 3, 2020·Clinics in Plastic Surgery·Greg I Lee, Michael W Neumeister
Jan 16, 2021·Expert Review of Medical Devices·Rodney A Gabriel, Brian M Ilfeld
Apr 13, 2021·Current Opinion in Supportive and Palliative Care·David J MageeMatthew R D Brown
Apr 7, 2021·Pain Medicine : the Official Journal of the American Academy of Pain Medicine·Rajat N MomanMatthew J Pingree
May 12, 2021·Current Pain and Headache Reports·Natalie H StrandJillian Maloney
Jun 2, 2021·Lancet·Helena KnotkovaMarc A Huntoon
Aug 3, 2021·Anesthesiology and Pain Medicine·Ezio Amorizzo, Gianni Colini-Baldeschi

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