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Please use this identifier to cite or link to this item: https://hdl.handle.net/11055/1259
Title: Long-Term Outcomes of Restorative Neurostimulation in Patients With Refractory Chronic Low Back Pain Secondary to Multifidus Dysfunction: Two-Year Results of the ReActiv8-B Pivotal Trial
Authors: Gilligan C
Volschenk W
Russo M 
Green M
Gilmore C
Mehta V
Deckers K
De Smedt K
Latif U
Georgius P 
Gentile J
Mitchell B
Langhorst M
Huygen F
Baranidharan G
Patel V
Mironer E
Ross E
Carayannopoulos A
Hayek S
Gulve A
Van Buyten JP
Tohmeh A
Fischgrund J
Lad S
Ahadian F
Deer T
Klemme W
Rauck R
Rathmell J
Maislin G
Heemels JP
Eldabe S
Keywords: Chronic low back pain
durability
functional segmental stability
multifidus muscle
restorative neurostimulation
Issue Date: Jan-2023
Source: 26(1):87-97.
Abstract: 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.
URI: https://hdl.handle.net/11055/1259
ISSN: 1094-7159
Appears in Collections:Scholarly and Clinical

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