ArticleNeurosurgery2023
Effect of Restorative Neurostimulation on Major Drivers of Chronic Low Back Pain Economic Impact.
Article in Neurosurgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
5 citing papers in PubMed, 6 citations in OpenAlex.
- ISASS Recommendations and Coverage Criteria for Restorative Neurostimulation for Multifidus Dysfunction, Lumbar Region: Coverage Indications, Limitations, and/or Medical Necessity-An ISASS 2025 Guideline Update.International journal of spine surgery · 2025Article
- The relationship of PROMIS physical function scores and healthcare resource utilization in patients treated for chronic low back pain.Interventional pain medicine · 2024Article
- Precision Rehabilitation After Neurostimulation Implantation for Multifidus Dysfunction in Nociceptive Mechanical Chronic Low Back Pain.Archives of rehabilitation research and clinical translation · 2024Article
- Multifidus dysfunction and restorative neurostimulation: a scoping review.Pain medicine (Malden, Mass.) · 2023Article
- International Society for the Advancement of Spine Surgery Statement: Restorative Neurostimulation for Chronic Mechanical Low Back Pain Resulting From Neuromuscular Instability.International journal of spine surgery · 2023Article
Corrections and comments
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Authors and funding
2 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundHigh-impact chronic low back pain (CLBP) correlates with high healthcare resource utilization. Therapies that can alter impact status may provide beneficial long-term economic benefits. An implantable restorative neurostimulation system (ReActiv8, Mainstay Medical) designed to over-ride multifidus inhibition to facilitate motor control restoration, thereby resolving mechanical low back pain symptoms, has shown significant durable clinical effects in moderately and severely impacted patients.
objectiveTo examine changes in high-impact chronic low back pain in patients treated with restorative neurostimulation at 2 years.
methodsReActiv8-B is a prospective, international, multicenter trial to evaluate the safety and efficacy of restorative neurostimulation in patients with intractable CLBP and no prior surgery. For this longitudinal subanalysis, patients were stratified into low-, moderate-, and high-impact CLBP categories using the US Department of Health and Human Services definition comprising pain intensity, duration, and impact on work, self-care, and daily activities.
resultsOf 2-year completers (n = 146), 71% had high-impact CLBP at baseline and this proportion reduced to 10%, with 85% reporting no or low impact. This corresponds with measurements of HRQoL returning to near-population norms.
conclusionIn addition to clinically meaningful improvements in pain and function with long-term durability, the overwhelming majority of patients transitioned from a high- to a no- or low-impact CLBP state. This is typically associated with significantly lower healthcare-utilization levels. The of recovery trajectory is consistent with a restorative mechanism of action and suggests that over the long term, the improvement in these health states will be maintained.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.