RESTORE : 1-Year Outcomes of Control Cross Over from Optimal Medical Management to Restorative Neurostimulation

Introduction: Restorative neurostimulation (ReActiv8, Mainstay Medical , Dublin Ireland) is a specific treatment for chronic mechanical low back pain resulting from multifidus muscle dysfunction. The primary endpoint of the RESTORE clinical trial demonstrated superiority of restorative neurostimulation over optimal medical management (OMM). This was consistent with published data from the ReActiv8-B clinical trial and real-world experience. In the second part of this Randomized Control Trial (RCT), we assessed clinical outcomes one year after crossover from (OMM) to restorative neurostimulation.

Methods: RESTORE is a multi-centre, open-label RCT, conducted at 23 clinical sites in the United States. Candidates were assessed for CLBP associated with multifidus dysfunction and general eligibility by the previously published criteria.2 Eligibility was verified by a three-member panel of independent medical experts prior to randomization. Conduct of the trial complied with the Declaration of Helsinki and Good Clinical Practice. Local institutional review board approval was obtained at each site. The results are reported in accordance with the CONSORT (Consolidated Standards of Reporting Trials) guidelines. Participants were randomized to Treatment with Restorative Neurostimulation with the ReActiv8 system or Control (OMM). At one year, patients were given the opportunity to cross over from OMM to the treatment group and outcomes were collected at 6 and 12 months following crossover.

Results: A total of 203 patients were randomised between treatment (n=99) and control (n=104). The average age of the participants was 47±12 years, BMI, 29±4 and duration of pain from first occurrence was 11.4±8.7 years. At baseline the treatment group has an ODI of 44±8, NRS 7.1±0.8, and EQ-5D 0.626±0.116 and the control group had an ODI of 44±8, NRS 7.1±0.9, and EQ-5D 0.613±0.125.

At the 1-year primary endpoint control group patients reported an average reduction in ODI of only 2.9±1.4, NRS of 0.6±0.2;and EQ5D of 0.008±0.012.2 At this time, 85%(80/94) of the control group completers elected to crossover to treatment. One year after the crossover, 97.5% (78/80 ) were available for followup and reported improvement from baseline in ODI, NRS and EQ-5D of 21.3±1.7, 3.8±0.3 and 0.192±0.017 respectively. Two-year mean(SE) improvement in outcomes from baseline for the treatment group continued to show maintenance of the improvements observed at the primary endpoint (ODI:24.6±1.9, NRS:4.2±0.3 EQ-5D:0.161±0.018) (Figure 1).

Conclusion: RESTORE is the second RCT to demonstrate the efficacy of restorative neurostimulation. This crossover portion of this study demonstrates the direct effect of restorative neurostimulation in patients who failed to respond to traditional CLBP therapies.

Keyword 1: Chronic Low Back Pain

Keyword 2: Multifidus Dysfunction

Keyword 3: Restorative Neurostimulation

Keyword 4: RCT

Keyword 5: Crossover

References : 1. Gilligan, C. et al. ReActiv8 stimulation therapy vs. Optimal medical management: A randomized controlled trial for the treatment of intractable mechanical chronic low back pain (RESTORE trial protocol). Pain Ther. 12, 607–620 (2023).
2. Schwab, F. et al. Restorative neurostimulation therapy compared to optimal medical management: A randomized evaluation (RESTORE) for the treatment of chronic mechanical low back pain due to multifidus dysfunction. Pain Ther. 14, 401–423 (2025).

Funding: Mainstay Medical