Study | Location | Study funding | Study design | # | Study groups # | Mean/median age | Waveform | Max follow-up |
RCT | ||||||||
Al-Kaisy et al 40 2022 | UK | Abbott | Double-blind cross-over RCT | 43 | 22—anatomic placement 21—paresthesia placement | 51.6 (12.1) | Burst SCS | 12M (n=39) |
De Andres et al 50 2017 | Spain | No funding received | Blinded RCT | 60 | 26—HF- SCS 29—SCS | 51.6 (9.3) 53.8 (11.46) | LH 40 Hz HF 10 kHz | 12M (n=55) |
Eldabe et al 55 2010 | Europe, Canada, Australia, and Israel | Medtronic | Multicenter RCT | 100 | 48—CMM 52—SCS+CMM | 50.4 (10.4) | Mean 49 Hz | 6M (n=94) |
Hara et al 22 2022 | Netherlands | Funded (Non-Industry) | Quadruple-blinded cross-over RCT | 50 | 47—Implanted | 52.2 (9.9) | Burst SCS | 3M |
Kapural et al 202161 | USA | Nevro Corp. | Multicenter RCT | 159 | 76—CMM alone 67—CMM to SCS 69—implanted | 58.5 (26-77) 53 (29–87) | HF 10 kHz | 12M (n=66) Crossover at 6M (n=55) |
Kumar et al 63 2007 | Europe, Canada, Australia, and Israel | Medtronic Inc. | Multicenter RCT | 100 | 48—CMM 52—SCS | 52 (10.7) 48.9 (10) | Mean 49 Hz | 12M (n=88) |
Rigoard et al 69 2019 | Europe, Colombia, UK, North America | Medtronic Inc. | Multicenter RCT | 218 | 108—CMM 110—CMM+SCS | 53.9 (11.5) | Not Specified | 24M (n=154) |
Non-RCT | ||||||||
Al-Kaisy et al 41 2014 | UK and Belgium | Nevro Corp. | Prospective, multicenter, single-arm study | 82 | 72—implanted | 50.8 (9.2) | 10 kHz | 24M (n=65) |
Barolat et al 42 2001 | USA | Not reported | Prospective, multicenter, single-arm study | 44 | 44—implanted | 48.8 (9.9) | Not Specified | 12M (n=15) |
Benyamin et al 43 2020 | North America | Medtronic Inc. | Prospective, multicenter, single-arm study | 44 | 32—implanted | 56 (11.9) | Variety | 3M (n=29) |
Bolash et al 44 2022 | USA | Stimwave Technologies | Prospective, single cohort study | 49 | 49—implanted | 59.9 (11) | LF, HF 10 kHz | 6M (n=39) |
Bondoc et al 45 2022 | USA | No funding received | Retrospective analysis | 189 | 154—under 65 years 35–65 years or older | 53.6 | Not Specified | 12M (n=189) |
Brooker et al 46 2021 | Australia | Saluda Medical | Prospective, multicenter, single-arm study | 70 | 50—implanted | 56.7 (12.2) | Closed loop SCS | 24M (n=38) |
Burchiel et al 47 1995 | USA | Medtronic Inc. | Prospective, single-arm study | 79 | 57—implanted | 51.6 (14.1) | Not Specified | 3M (n=45) |
Campwala et al 48 2021 | USA | No funding received | Retrospective analysis | 134 | 82—Spine surgery 52—no spine surgery | 56.2 (11.7) 51.4 (11.6) | Variety | 12M |
Costantini et al 49 2010 | Europe | Medtronic Europe | Retrospective analysis | 69 | 69—implanted | 70 (10.1) | Not Specified | Median=24M |
De Jaeger et al 51 2019 | Belgium | Medtronic Europe | Prospective, multicenter, single-arm study | 81 | 81—implanted | 54.6 (10.1) | 500 Hz | 3M (n=81) |
Delmotte et al 52 2015 | France and Canada | Not reported | Retrospective subgroup analysis | 72 | 21—optimized lead positioning 51—non-optimized | 52.1 (8.7) | 90 Hz | 6M (n=71) |
DiBenedetto et al 53 2018 | USA | Nevro Corp. | Retrospective, matched sample, cohort study | 96 | 64—CMM 32—SCS+CMM | 55.2 (14.7) 56 (10) | 10 kHz | 12M (n=96) |
Do et al 54 2021 | Belgium | No funding received | Retrospective analysis | 208 | 183—implanted | 52 | Variety | 24M |
Goudman et al 56 2021 | Belgium and France | Medtronic Europe | Prospective, multicenter, single-arm study | 185 | 139—implanted | 54 (12.01) | 450–500 Hz | 12M (n=92) |
Harman et al 57 2020 | Turkey | Not reported | Retrospective analysis | 19 | 16—implanted | 50 (35–80) | Not Specified | Mean 18.3M (SD 3.9) |
Jonsson et al 58 2020 | Sweden | Medtronic Inc. | Retrospective, database, cohort study | 73 765 | 73,765—Spine surgery 239— SCS+Spine Surgery | 55.1 (17) 47.4 (12) | Not Specified | At least 2Y |
Kallewaard et al 59 2021 | Netherlands | Nevro Corp. | Prospective, uncontrolled, open-label study | 68 | 58—implanted | 52.6 (11.3) | 10 kHz | 12M (n=50) |
Kamieniak et al 60 2019 | Poland | Not reported | Prospective, controlled study | 48 | 24—controls 17—implanted | 56.7 (10.48) 55.9 (11.6) | 40–80 Hz | 3M (n=12) |
Kinfe et al 62 2014 | Germany | Not reported | Prospective, nonrandomized study | 100 | 50—paddle leads 50—cylindrical lead | 56.3 (11.5) | 30–130 Hz | 6M |
Mehta et al 64 2022 | UK | Medtronic Inc. | Prospective, open-label, single-arm study | 20 | 19—implanted | Not reported | 500 Hz | 12M (n=16) |
Mosiewicz et al 65 2015 | Poland | Not reported | Prospective, single-arm study | 36 | 36—implanted | 59.6 (9.4) | Not Specified | 6M (n=36) |
Mullins et al 66 2022 | Canada | No funding received | Retrospective analysis | 25 | 25—implanted | 58.2 (SEM: 55.8–60.7) | Not Specified | 6M (n=23) |
Paul et al 67 2017 | USA | Not reported | Retrospective analysis | 48 | 35—successful SCS 13—failed SCS | 51.4 (11.9) 57.2 (13.2) | Not Specified | 6M (n=48) |
Perez et al 68 2021 | Spain | Boston Scientific Iberica | Prospective, multicenter, observational study | 85 | 46—CMM 39—SCS | 60.8 (SE 1.8) 53 (SE 1.8) | Variety | 24M (n=54) |
Slavin et al 70 1999 | USA | Not reported | Prospective, single-arm study | 10 | 10—implanted | 49 (7) | Not Specified | 1M (n=10) |
Spincemaille et al 71 2004 | Netherlands | Medtronic Netherlands | Prospective, single-arm study | 135 | 105—implanted | 52.5 (9.5) | Not Specified | 12M (n=96) |
Van Buyten et al 72 2013 | Belgium and UK | Nevro Corp. | Prospective, multicenter, single-arm study | 83 | 72—implanted | 50.4 (9.5) | 10 kHz | 6M (n=72) |
Van Heteren et al 73 2022 | Netherlands | Medtronic funded RCT | Subanalysis of prior RCT | 100 | 65—SCS+PNFS 25—SCS only | 50.4 (10.7) 53.1 (11.6) | Not Specified | 12M (n=75) |
Zucco et al 74 2015 | Italy | Medtronic Italy | Observational, multicenter, ambispective study | 80 | 72—implanted | 58 (13) | No Not Specified | 24M (n=55) |
CMM, conventional medical management; HF-SCS, high frequency SCS; Hz, hertz; LF-SCS, Low Frequency SCS; M, months; PNFS, peripheral nerve field stimulation; RCT, randomised controlled trial; SCS, spinal cord stimulation; SD, standard deviation; SEM, standard error of the mean; Y, years.