Mainstay Medical's ReActiv8 restorative neurostimulation system has shown promising results in the treatment of intractable chronic low back pain (CLBP), according to the one-year primary assessment results from the RESTORE clinical trial. The study, a multi-center, prospective, randomized trial, demonstrated that ReActiv8, when added to optimal medical management, led to superior improvements in back pain-related disability, pain intensity, and overall quality of life compared to standard of care treatments alone.
The RESTORE trial, which involved 203 patients across 23 centers in the U.S., randomized participants to either optimized medical management or ReActiv8 therapy plus optimized medical management. The primary endpoint focused on the mean improvement in the Oswestry Disability Index (ODI) score at the one-year follow-up. Key findings revealed a statistically significant (p<0.001) and clinically meaningful mean change in the ReActiv8 group compared to the control arm, with an ODI improvement of -19.7 ± 1.4 versus -2.9 ± 1.4, respectively.
Significant Improvements in Secondary Endpoints
In addition to the primary endpoint, all secondary endpoints exhibited statistically significant differences between the ReActiv8 and control groups (p<0.001). These included:
- Pain Reduction: The ReActiv8 group experienced a mean improvement in back pain, measured using the 11-point Numeric Rating Scale (NRS), of -3.6 ± 0.2, compared to -0.6 ± 0.2 in the control group.
- Quality of Life: Healthcare-related quality of life, assessed via the EQ-5D-5L, showed a mean improvement of +0.155 ± 0.012 for the ReActiv8 group versus +0.008 ± 0.012 for the control group. This improvement brought the ReActiv8 group's mean quality of life score closer to the average score of the overall U.S. population.
- Composite Endpoint: A significant 72% of patients in the ReActiv8 group achieved the composite endpoint of ≥15-point ODI improvement and/or ≥50% NRS improvement with no worsening in either measure, compared to only 11% in the control group (p<0.001).
- Pain Remission: Pain remission, defined as an NRS score of ≤3 at one year, was observed in 52% of patients in the ReActiv8 group, while only 6% of the control group achieved this level of pain reduction.
Expert Commentary
The steering committee of the RESTORE study, consisting of Dr. Frank Schwab, Dr. Chris Gilligan, Dr. Nagy Mekhail, and Dr. Kiran Patel, stated, "This patient population has historically had extremely limited options beyond temporary palliative treatments and drugs. The results in this study demonstrated that ReActiv8 Restorative Neurostimulation provided superior improvements to the lives of patients above and beyond what is currently used to treat them."
Jason Hannon, CEO of Mainstay Medical, added, "These high-quality data showing the treatment benefit of ReActiv8 compared to the current standard of care meaningfully add to the growing body of clinical evidence regarding ReActiv8 and firmly establishes the critical role of this therapy in treating intractable mechanical low back pain patients."
ReActiv8: Targeting Multifidus Muscle Dysfunction
ReActiv8 is an implantable medical device designed to treat adults with intractable CLBP associated with multifidus muscle dysfunction, a primary underlying cause of mechanical chronic low back pain. Candidates for ReActiv8 are patients who have failed other forms of therapy, including pain medication and physical therapy, and are not candidates for spine surgery. The device is commercially available in the European Economic Area, Australia, the UK, and the US.
Safety Profile
The adverse event profile observed in the RESTORE trial was consistent with previously reported ReActiv8 studies and was considered favorable compared to other neuromodulation treatment procedures.
