Introduction: Restorative neurostimulation has been suggested as a specific treatment for chronic mechanical low back pain associated with multifidus dysfunction (CLBP).1 In the RESTORE randomized controlled trial (RCT), the aim was to assess clinical outcomes in patients with CLBP randomized to either a restorative neurostimulation group or to a control group receiving optimal medical management (OMM) over one year.
Methods: RESTORE is a multi-center, open-label RCT involving patients from 23 United States clinical sites. Trial conduct complied with FDA regulations, Declaration of Helsinki, and Good Clinical Practices. Local institutional review board or ethics committee approvals were obtained at the sites, and results were reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Candidates were assessed for CLBP and general eligibility by previously published criteria.2 Eligibility was verified by a three-member panel of independent medical experts prior to randomization. Consented participants were randomized to either receive restorative neurostimulation or OMM for one year. Clinical outcomes of Oswestry Disability Index (ODI), Numeric Pain Rating Scale (NRS), and Euroqol’s EQ-5D-5L (EQ-5D) were evaluated.
Results: A total of 203 participants (mean age=47±12yrs; BMI=29±4kg/m2; pain duration from first occurrence=11.4±8.7yrs) were randomized between treatment (n=99) and control (n=104). At baseline, the treatment group had an ODI of 44±8, NRS 7.1±0.8, and EQ-5D 0.626±0.116. Similarly, the control group had an ODI of 44±8, NRS 7.1±0.9, and EQ-5D 0.613±0.125.
The primary endpoint demonstrated a statistically significant, clinically relevant mean improvement in ODI between restorative neurostimulation and OMM arms (-19.7±1.4 vs. -2.9±1.4; p< 0.001). Additionally, improvements in both NRS (-3.6±0.2 vs. -0.6±0.2; p< 0.001) and EQ-5D (0.155±0.012 vs. 0.008±0.012; p< 0.001) were statistically and clinically significant with restorative neurostimulation compared to OMM.
Conclusion : RESTORE is the second RCT to demonstrate comparative efficacy of restorative neurostimulation, and is safe, reversible, clinically effective, and exceptionally durable as an option for patients suffering with non-operative CLBP. This demonstration of treatment superiority over OMM through one year is a significant milestone in addressing a major health burden and unmet clinical need.
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