Mainstay Medical has announced the completion of enrolment in its RESTORE randomised clinical study of ReActiv8 for the treatment of intractable chronic low back pain. The study is designed to provide a direct comparison to optimised medical management for the purpose of testing the hypothesis that the addition of ReActiv8 restorative neurostimulation therapy to current care paradigms results in significant improvements in back pain-related disability.
The RESTORE study is a multicentre, prospective randomised controlled trial that has been conducted at 25 leading centres in the USA, according to Mainstay. A total of 226 eligible patients were randomised to either continue with their optimal medical management or ReActiv8 restorative neurostimulation therapy plus optimal medical management.
Patient-reported outcomes are being collected at regular intervals out to the one-year primary endpoint, at which time the patients in the control arm are offered implantation with the ReActiv8 system. Assessment of the patients will also continue for an additional year.
The co-principal investigators of the RESTORE study are Frank Schwab (Lenox Hill Hospital/Northwell Health System, New York, USA), Chris Gilligan (Brigham and Women’s Hospital/Harvard Medical School, Boston, USA), and Kiran Patel (NYC Neuromodulation Center of Excellence, New York, USA).
“This type of randomised controlled clinical trial in this difficult-to-treat and underserved patient population will produce high-quality data comparing ReActiv8 to the current standard of care,” said the RESTORE investigators. “Once the data are published, they will meaningfully add to the growing body of clinical evidence regarding ReActiv8 and firmly establish the role of this therapy in treating mechanical low back pain patients.
“The RESTORE trial represents a substantial addition to the clinical evidence behind treatment options for this patient population, who have extremely limited options beyond temporary palliative treatments and drugs. Directly addressing the underlying issue of muscular dysfunction can represent a substantial advancement in treatment options.
“We would like to express sincere thanks to the patients who agreed to be screened for this study, the trial investigators and their hard-working staff, and the Mainstay team for their passion and commitment to the programme. We look forward to the results of this trial to prove the degree to which ReActiv8 can improve the lives of these patients above and beyond what is currently used to treat them.”