TY - JOUR
T1 - Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction
T2 - Two-Year Results of the ReActiv8-B Pivotal Trial
AU - Gilligan, Christopher
AU - Volschenk, Willem
AU - ReActiv8-B investigators
AU - Russo, Marc
AU - Green, Matthew
AU - Gilmore, Christopher
AU - Mehta, Vivek
AU - Deckers, Kristiaan
AU - De Smedt, Kris
AU - Latif, Usman
AU - Georgius, Peter
AU - Gentile, Jonathan
AU - Mitchell, Bruce
AU - Langhorst, Meredith
AU - Huygen, Frank
AU - Baranidharan, Ganesan
AU - Patel, Vikas
AU - Mironer, Eugene
AU - Ross, Edgar
AU - Carayannopoulos, Alexios
AU - Hayek, Salim
AU - Gulve, Ashish
AU - Van Buyten, Jean Pierre
AU - Tohmeh, Antoine
AU - Fischgrund, Jeffrey
AU - Lad, Shivanand
AU - Ahadian, Farshad
AU - Deer, Timothy
AU - Klemme, William
AU - Rauck, Richard
AU - Rathmell, James
AU - Maislin, Greg
AU - Heemels, Jan Pieter
AU - Eldabe, Sam
N1 - Funding Information:
Source(s) of financial support: This study was funded by Mainstay Medical .
Publisher Copyright:
© 2021 The Authors
PY - 2023/1
Y1 - 2023/1
N2 - Background: Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. Objective: This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. Materials and Methods: Open-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. Results: At two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. Conclusions: At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. Clinical Trial Registration: The study is registered on clinicaltrials.gov with identifier NCT02577354.
AB - Background: Impaired neuromuscular control and degeneration of the multifidus muscle have been linked to the development of refractory chronic low back pain (CLBP). An implantable restorative-neurostimulator system can override the underlying multifidus inhibition by eliciting episodic, isolated contractions. The ReActiv8-B randomized, active-sham-controlled trial provided effectiveness and safety evidence for this system, and all participants received therapeutic stimulation from four months onward. Objective: This study aimed to evaluate the two-year effectiveness of this restorative neurostimulator in patients with disabling CLBP secondary to multifidus muscle dysfunction and no indications for spine surgery. Materials and Methods: Open-label follow-up of 204 participants implanted with a restorative neurostimulation system (ReActiv8, Mainstay Medical, Dublin, Ireland) was performed. Pain intensity (visual analog scale [VAS]), disability (Oswestry disability index [ODI]), quality-of-life (EQ-5D-5L), and opioid intake were assessed at baseline, six months, one year, and two years after activation. Results: At two years (n = 156), the proportion of participants with ≥50% CLBP relief was 71%, and 65% reported CLBP resolution (VAS ≤ 2.5 cm); 61% had a reduction in ODI of ≥20 points, 76% had improvements of ≥50% in VAS and/or ≥20 points in ODI, and 56% had these substantial improvements in both VAS and ODI. A total of 87% of participants had continued device use during the second year for a median of 43% of the maximum duration, and 60% (34 of 57) had voluntarily discontinued (39%) or reduced (21%) opioid intake. Conclusions: At two years, 76% of participants experienced substantial, clinically meaningful improvements in pain, disability, or both. These results provide evidence of long-term effectiveness and durability of restorative neurostimulation in patients with disabling CLBP, secondary to multifidus muscle dysfunction. Clinical Trial Registration: The study is registered on clinicaltrials.gov with identifier NCT02577354.
UR - http://www.scopus.com/inward/record.url?scp=85124810046&partnerID=8YFLogxK
U2 - 10.1016/j.neurom.2021.10.011
DO - 10.1016/j.neurom.2021.10.011
M3 - Article
C2 - 35088722
AN - SCOPUS:85124810046
SN - 1094-7159
VL - 26
SP - 87
EP - 97
JO - Neuromodulation
JF - Neuromodulation
IS - 1
ER -