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Back Pain Device Shows Lasting Results
4 Sep
Summary
- ReActiv8 therapy demonstrated continued improvements over two years.
- Eighty-three percent of control patients crossed over to ReActiv8.
- New study results were published in The Spine Journal.
Mainstay Medical Holdings plc has released two-year findings from its RESTORE randomized clinical trial assessing ReActiv8 for chronic low back pain. The study observed ongoing improvements in patient-reported disability, pain levels, and quality of life.
Results indicated that patients who crossed over to ReActiv8 therapy after one year showed improvements indistinguishable from the initial treatment group. These findings were published in The Spine Journal.
The trial involved 203 patients, with significant positive outcomes noted in both the treatment and crossover groups regarding Oswestry Disability Index (ODI) and Numeric Rating Scale (NRS) scores.
Adverse event profiles were comparable to previous ReActiv8 studies and favorable when contrasted with other neuromodulation treatments. The company aims to expand insurance access for ReActiv8 in the United States.
