BACKGROUND: Spinal cord stimulation (SCS) is an established therapy for chronic neuropathic pain and most frequently utilised for Failed Back Surgery Syndrome (FBSS). BurstDR™ also known as DeRidder Burst-SCS, a novel waveform, has demonstrated superiority to conventional tonic stimulation of the thoracic spine in FBSS. There are case reports of an improvement in multidimensional pain outcomes using DeRidder Burst-SCS in the cervical spine for chronic neck and cervical radicular pain. The safety and efficacy of cervical DeRidder Burst-SCS stimulation still however remain undetermined. METHODS/ DESIGN: This is a prospective, multicentre feasibility trial evaluating the safety and therapeutic efficacy of DeRidder Burst-SCS stimulation for the treatment of chronic intractable neck pain with or without radiation to the arm, shoulder, and upper back. After baseline evaluation, subjects will undergo an SCS trial using the Abbott Invisible Trial system according to standard clinical procedures. During the trial phase, SCS leads will be implanted in the cervical epidural space. At the end of the SCS trial, subjects experiencing at least 50% pain relief will be considered for permanent implant. Pain intensity, medication usage, and other multidimensional pain outcomes will be collected. The timing of these will be at baseline, end of the SCS trial and at 3-, 6-, and 12-month visits. Incidence of adverse events will be collected throughout the study duration. DISCUSSION: The results of this feasibility study will validate the efficacy and safety of DeRidder Burst-SCS stimulation in the cervical spine. The results obtained in this study will potentially be used to generate a level 1 evidence-based study with formal statistical hypotheses testing. TRIAL REGISTRATION: www.clinicaltrials.gov Identifier: NCT03159169.
BACKGROUND: Spinal cord stimulation (SCS) is an established therapy for chronic neuropathic pain and most frequently utilised for Failed Back Surgery Syndrome (FBSS). BurstDR™ also known as DeRidder Burst-SCS, a novel waveform, has demonstrated superiority to conventional tonic stimulation of the thoracic spine in FBSS. There are case reports of an improvement in multidimensional pain outcomes using DeRidder Burst-SCS in the cervical spine for chronic neck and cervical radicular pain. The safety and efficacy of cervical DeRidder Burst-SCS stimulation still however remain undetermined. METHODS/ DESIGN: This is a prospective, multicentre feasibility trial evaluating the safety and therapeutic efficacy of DeRidder Burst-SCS stimulation for the treatment of chronic intractable neck pain with or without radiation to the arm, shoulder, and upper back. After baseline evaluation, subjects will undergo an SCS trial using the Abbott Invisible Trial system according to standard clinical procedures. During the trial phase, SCS leads will be implanted in the cervical epidural space. At the end of the SCS trial, subjects experiencing at least 50% pain relief will be considered for permanent implant. Pain intensity, medication usage, and other multidimensional pain outcomes will be collected. The timing of these will be at baseline, end of the SCS trial and at 3-, 6-, and 12-month visits. Incidence of adverse events will be collected throughout the study duration. DISCUSSION: The results of this feasibility study will validate the efficacy and safety of DeRidder Burst-SCS stimulation in the cervical spine. The results obtained in this study will potentially be used to generate a level 1 evidence-based study with formal statistical hypotheses testing. TRIAL REGISTRATION: www.clinicaltrials.gov Identifier: NCT03159169.
Authors: Jay S Grider; Laxmaiah Manchikanti; Alexios Carayannopoulos; Manohar Lal Sharma; Carl C Balog; Michael E Harned; Vahid Grami; Rafael Justiz; Kent H Nouri; Salim M Hayek; Ricardo Vallejo; Paul J Christo Journal: Pain Physician Date: 2016-01 Impact factor: 4.965
Authors: Krishna Kumar; Rod S Taylor; Line Jacques; Sam Eldabe; Mario Meglio; Joan Molet; Simon Thomson; Jim O'Callaghan; Elon Eisenberg; Germain Milbouw; Eric Buchser; Gianpaolo Fortini; Jonathan Richardson; Richard B North Journal: Pain Date: 2007-09-12 Impact factor: 6.961
Authors: Marleen C Tjepkema-Cloostermans; Cecile C de Vos; Rian Wolters; Cindy Dijkstra-Scholten; Mathieu W P M Lenders Journal: Neuromodulation Date: 2016-04-05
Authors: Timothy R Deer; Nagy Mekhail; David Provenzano; Jason Pope; Elliot Krames; Michael Leong; Robert M Levy; David Abejon; Eric Buchser; Allen Burton; Asokumar Buvanendran; Kenneth Candido; David Caraway; Michael Cousins; Michael DeJongste; Sudhir Diwan; Sam Eldabe; Kliment Gatzinsky; Robert D Foreman; Salim Hayek; Philip Kim; Thomas Kinfe; David Kloth; Krishna Kumar; Syed Rizvi; Shivanand P Lad; Liong Liem; Bengt Linderoth; Sean Mackey; Gladstone McDowell; Porter McRoberts; Lawrence Poree; Joshua Prager; Lou Raso; Richard Rauck; Marc Russo; Brian Simpson; Konstantin Slavin; Peter Staats; Michael Stanton-Hicks; Paul Verrills; Joshua Wellington; Kayode Williams; Richard North Journal: Neuromodulation Date: 2014-08