Shots:
- The RESTORE trial assessed the ReActiv8 Restorative Neurostimulation therapy (n=99) vs SoC (n=104) for 1yr. to treat intractable chronic low back pain in patients (N=203)
- The data showed a mean improvement in ODI score (1EP; -19.7 ± 1.4 vs -2.9 ± 1.4), back pain measured by 11-pts. NRS (2EPs; -3.6 ± 0.2 vs -0.6 ±0.2), quality of life measured by EQ-5D-5L test (2EPs; +0.155 ± 0.012 vs +0.008 ± 0.012)
- In Addition, 72% vs 11% patients had ≥15pts. ODI &/or ≥50% NRS improvement & no worsening in either for 1yr., plus pain remission (≤3 NRS) was observed in 52% vs 6% patients with favorable safety. Data published in Pain & Therapy
Ref: Businesswire | Image: Mainstay Medical
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