Paul Verrills1, John Salmon2, Marc Russo3, Bradford Gliner4, Adele Barnard5, David Caraway4. 1. Metro Pain Group, Clayton, VIC, Australia. 2. PainCare, Perth, WA, Australia. 3. Genesis Research Services, Broadmeadow, NSW, Australia. 4. Nevro Corp, Redwood City, CA, USA. 5. Nevro Corp, Redwood City, CA, USA. adele.barnard@nevro.com.
Abstract
PURPOSE: Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. The purpose of this Australian multi-centre prospective, clinical trial was to assess the safety and effectiveness of paraesthesia-independent 10 kHz SCS for the treatment of upper limb and neck pain. METHODS: Subjects with chronic, intractable neck and/or upper limb pain of ≥ 5 cm (on a 0-10-cm visual analogue scale) were enrolled (ACTRN12614000153617) following human research ethics committee approval. Subjects were implanted with two epidural leads spanning C2-C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza® system (Nevro Corp., Redwood City, CA, USA) and included in the safety and effectiveness evaluation at 3 months post-implant (primary endpoint assessment, PEA) and followed to 12 months. RESULTS: Overall, 31/38 (82.6%) subjects reported a successful 10 kHz SCS trial and proceeded to a permanent implant. Twenty-three of 30 subjects (76.7%) met the PEA. Subjects reported a reduction in neck pain and upper limb pain from baseline at the PEA (8.1 ± 0.2 cm vs. 2.9 ± 0.5 cm, 7.3 ± 0.3 cm vs. 2.5 ± 0.5 cm, respectively, p ≤ 0.0001). Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA. Results were maintained 12 months post-implant. No neurological deficits, nor reports of paraesthesia, were observed. CONCLUSIONS: Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain.
PURPOSE: Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. The purpose of this Australian multi-centre prospective, clinical trial was to assess the safety and effectiveness of paraesthesia-independent 10 kHz SCS for the treatment of upper limb and neck pain. METHODS: Subjects with chronic, intractable neck and/or upper limb pain of ≥ 5 cm (on a 0-10-cm visual analogue scale) were enrolled (ACTRN12614000153617) following human research ethics committee approval. Subjects were implanted with two epidural leads spanning C2-C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza® system (Nevro Corp., Redwood City, CA, USA) and included in the safety and effectiveness evaluation at 3 months post-implant (primary endpoint assessment, PEA) and followed to 12 months. RESULTS: Overall, 31/38 (82.6%) subjects reported a successful 10 kHz SCS trial and proceeded to a permanent implant. Twenty-three of 30 subjects (76.7%) met the PEA. Subjects reported a reduction in neck pain and upper limb pain from baseline at the PEA (8.1 ± 0.2 cm vs. 2.9 ± 0.5 cm, 7.3 ± 0.3 cm vs. 2.5 ± 0.5 cm, respectively, p ≤ 0.0001). Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA. Results were maintained 12 months post-implant. No neurological deficits, nor reports of paraesthesia, were observed. CONCLUSIONS: Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain.
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
Authors: Erika A Petersen; Thomas G Stauss; James A Scowcroft; Elizabeth S Brooks; Judith L White; Shawn M Sills; Kasra Amirdelfan; Maged N Guirguis; Jijun Xu; Cong Yu; Ali Nairizi; Denis G Patterson; Kostandinos C Tsoulfas; Michael J Creamer; Vincent Galan; Richard H Bundschu; Neel D Mehta; Dawood Sayed; Shivanand P Lad; David J DiBenedetto; Khalid A Sethi; Johnathan H Goree; Matthew T Bennett; Nathan J Harrison; Atef F Israel; Paul Chang; Paul W Wu; Charles E Argoff; Christian E Nasr; Rod S Taylor; David L Caraway; Nagy A Mekhail Journal: Mayo Clin Proc Innov Qual Outcomes Date: 2022-07-01
Authors: Abram Burgher; Peter Kosek; Steven Surrett; Steven M Rosen; Todd Bromberg; Ashish Gulve; Anu Kansal; Paul Wu; W Porter McRoberts; Ashish Udeshi; Michael Esposito; Bradford E Gliner; Mona Maneshi; Anand Rotte; Jeyakumar Subbaroyan Journal: J Pain Res Date: 2020-11-10 Impact factor: 3.133