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

The American Society of Pain and Neuroscience (ASPN) Evidence-Based Clinical Guideline of Interventional Treatments for Low Back Pain

“…This trial demonstrated clinical effectiveness as measured by substantial and durable improvements in pain, disability, and quality of life in a cohort of patients with a favorable benefit risk profile. 339 , 340 …”

“…The highest level trial of the permanently implanted PNS system was an international, multi-center, prospective, randomized, active, sham controlled, blinded trial, which generated high, level I-A evidence supporting the significance of the treatment effect. 339 , 340 The study was conducted at 24 sites in the US, Australia, and Europe. A total enrollment of 204 subjects were implanted with the permanently implanted PNS system and randomized (1:1) to the treatment or control group.…”

“… Gilligan et al, 2021 339 Randomized, multi-center, active- sham-controlled clinical trial 204 I-A Comparison of responder subjects with greater than or equal to 30% relief on VAS (LBP) without analgesic increase at 120 days; ODI, EQ-5D, PPR, PGIC, and LBP resolution The primary endpoint comparing the responder proportions was inconclusive in superiority; however, prespecified secondary outcomes and analyses were consistent with a modest but clinically significant meaningful treatment benefit at 120 days. Gilligan et al, 2021 340 Open-label follow up of randomized, active-sham-controlled trial 204 I-C VAS, ODI, EQ-5D-5L, opioid intake at 6, 12, and 24 months At two years, 76% subjects experienced ≥50% CLBP relief and 65% reported CLBP resolution; 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. Kapural et al, 2018 341 Case report 2 II BPI, ODI 2 subjects experienced clinically significant reductions in average BPI at end of therapy, which was sustained at 4 months with at least 50% reduction in ODI and 83% reduction in BPI, revealing the utility of minimally invasive neuromodulation therapy Gilmore et al, 2019 342 Case Series 9 II BPI-3, BPI-5 Among responders at four months, the mean reduction in average pain intensity (BPI-5) and worst pain intensity (BPI-3) was 84% and 78%, respectively.…”

Restorative Neurostimulation: A Clinical Guide for Therapy Adoption

“…50 A longitudinal follow-up of 156 patients from the ReActiv8-B trial for whom complete 2-year data were available showed that 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. 51 Mean EQ-5D had improved from 0.585 to 0.798, which approached the US population norm. 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.…”

Nonsurgical Interventional Spine Pain Procedures

“…It elicits episodic and isolated contractions in the lumbar multifidus muscle, enhancing lower back stabilization for refractory chronic LBP. After 2 years, 71% of patients reported relief and 65% reported resolution of their symptoms 90 .…”