Mainstay Medical has announced the publication of positive one-year primary assessment results from the RESTORE randomised clinical trial evaluating ReActiv8 for the treatment of intractable chronic low back pain. The data show that the addition of ReActiv8 restorative neurostimulation therapy to the current standard of care results in superior improvements in back pain-related disability, pain, and quality of life, compared to standard-of-care treatments alone. The results have been published in the journal Pain and Therapy.
The study included 203 patients, with 99 randomised into the treatment arm and 104 randomised into the control arm.
Its primary endpoint—mean improvement in Oswestry disability index (ODI) score between the treatment and control arms at the one-year follow-up visit—was statistically significant (p<0.001), with a clinically meaningful mean change in the ReActiv8 group (ODI, -19.7±1.4) compared to the control arm (ODI, -2.9±1.4).
In addition, all secondary endpoints showed statistically significant differences between the ReActiv8 and control arms—as well as clinically meaningful improvements for the ReActiv8 arm—at one year, including:
- Mean improvement in back pain measured using the 11-point numeric rating scale (NRS) in the ReActiv8 group (NRS, -3.6±0.2) versus the control group (NRS, -0.6±0.2; p<0.001)
- Mean improvement in healthcare-related quality of life measured using the EQ-5D-5L assessment in the ReActiv8 group (+0.155±0.012) versus the control group (+0.008±0.012; p<0.001), with improvements in the ReActiv8 group resulting in a mean quality-of-life score approaching the average across the overall US population
In a press release, Mainstay notes that the proportion of patients who reached the composite endpoint of ≥15-point ODI improvement and/or ≥50% NRS improvement, and no worsening in either measure, at one year was 72% in the ReActiv8 group and 11% in the control group (p<0.001). Pain remission—defined as NRS ≤3 at one year—was observed in 52% of patients in the ReActiv8 group and in 6% of those in the control group.
The profile of related adverse events in RESTORE was similar to previously reported ReActiv8 studies and favourable to other neuromodulation treatment procedures, Mainstay further claims.
“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,” said RESTORE study steering committee members Frank Schwab (Lenox Hill Hospital/ Northwell Health System, New York, USA), Chris Gilligan (Robert Wood Johnson University Hospital, New Brunswick, USA), Nagy Mekhail (Cleveland Clinic/Case Western Reserve University, Cleveland, USA) and Kiran Patel (Lenox Hill Hospital/New York City [NYC] Neuromodulation Center of Excellence, New York, USA). “These exciting results further validate ReActiv8’s restorative mechanism of action treating multifidus dysfunction, a primary underlying cause of mechanical chronic lower back pain in certain patients. Combining these impressive results with the newly issued ICD-10 code for multifidus dysfunction, this study further demonstrates the ability of clinicians to confidently select and treat patients with chronic mechanical low back pain who were previously very difficult to treat.”
“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 establish the critical role of this therapy in treating intractable mechanical low back pain patients,” added Mainstay chief executive officer (CEO) Jason Hannon. “We are proud to have the only commercially available device with a strong safety profile and long-term, peer-reviewed evidence supporting the rehabilitation of this severely affected patient population. We look forward to leveraging these data, along with the compelling results from our ReActiv8-B clinical trial and our numerous other studies, to further engage payers in the USA to expand commercial insurance access to this transformational therapy, which has the potential to deliver significant reductions in overall healthcare costs.”
