Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction
Abstract Introduction Many interventional strategies are commonly used to treat chronic low back pain (CLBP), though few are specifically intended to target the distinct underlying pathomechanisms causing low back pain. Restorative neurostimulation has been suggested as a specific treatment for mech...
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Adis, Springer Healthcare
2025-01-01
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| Series: | Pain and Therapy |
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| Online Access: | https://doi.org/10.1007/s40122-024-00689-0 |
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| author | Frank Schwab Nagy Mekhail Kiran V. Patel Meredith Langhorst Robert D. Heros Jonathan Gentile Sherif Costandi Gregory Moore Christopher Gilmore Smith Manion Krishnan Chakravarthy S. Craig Meyer Justin V. Bundy Jordan L. Tate Rebecca Sanders Sandeep Vaid Oszkar Szentirmai Johnathan Goree Vikas V. Patel Jeff Lehmen Mehul J. Desai Jason E. Pope Anthony Giuffrida Salim Hayek Sohrab Singh Virk Richard Paicius William R. Klemme Robert Levy Christopher Gilligan the RESTORE investigators |
| author_facet | Frank Schwab Nagy Mekhail Kiran V. Patel Meredith Langhorst Robert D. Heros Jonathan Gentile Sherif Costandi Gregory Moore Christopher Gilmore Smith Manion Krishnan Chakravarthy S. Craig Meyer Justin V. Bundy Jordan L. Tate Rebecca Sanders Sandeep Vaid Oszkar Szentirmai Johnathan Goree Vikas V. Patel Jeff Lehmen Mehul J. Desai Jason E. Pope Anthony Giuffrida Salim Hayek Sohrab Singh Virk Richard Paicius William R. Klemme Robert Levy Christopher Gilligan the RESTORE investigators |
| author_sort | Frank Schwab |
| collection | DOAJ |
| description | Abstract Introduction Many interventional strategies are commonly used to treat chronic low back pain (CLBP), though few are specifically intended to target the distinct underlying pathomechanisms causing low back pain. Restorative neurostimulation has been suggested as a specific treatment for mechanical CLBP resulting from multifidus dysfunction. In this randomized controlled trial, we report outcomes from a cohort of patients with CLBP associated with multifidus dysfunction treated with restorative neurostimulation compared to those randomized to a control group receiving optimal medical management (OMM) over 1 year. Methods RESTORE is a multicenter, open-label randomized controlled trial. Candidates were assessed for CLBP associated with multifidus dysfunction, with no indication for or history of lumbar spine surgery. Participants were randomized to either restorative neurostimulation with the ReActiv8 system or OMM. The primary endpoint was a comparison of the mean change in the Oswestry Disability Index (ODI) between the treatment and control arms at 1 year, and secondary endpoints included pain (numeric rating scale [NRS]) and health-related quality of life (EuroQol Five-Dimension [EQ-5D-5L]). Results A total of 203 patients, average age 47 years, and with an average 11-year history of low back pain, were included in the analysis. The primary endpoint was a statistically significant demonstration of a clinically relevant mean improvement in the Oswestry Disability Index (ODI) between restorative neurostimulation and OMM arms: ODI (−19.7 ± 1.4 vs. −2.9 ± 1.4; p < 0.001). Additionally, improvements in both the numeric rating scale (NRS) (−3.6 ± 0.2 vs. −0.6 ± 0.2; p < 0.001) and EuroQol Five-Dimension (EQ-5D-5L) (0.155 ± 0.012 vs. 0.008 ± 0.012; p < 0.001) were statistically and clinically significant in the restorative neurostimulation arm compared to the OMM arm. Conclusion The RESTORE trial demonstrates that restorative neurostimulation is a safe, reversible, clinically effective, and highly durable option for patients suffering with nonoperative CLBP associated with multifidus dysfunction. This demonstration of treatment superiority over OMM through 1 year is a significant milestone in addressing a major health burden and unmet clinical need. Trial Registration ClinicalTrials.gov Identifier: NCT04803214. |
| format | Article |
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| institution | Kabale University |
| issn | 2193-8237 2193-651X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Adis, Springer Healthcare |
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| series | Pain and Therapy |
| spelling | doaj-art-7bdce2969a12415ab61799fb153a9fb32025-01-26T12:14:04ZengAdis, Springer HealthcarePain and Therapy2193-82372193-651X2025-01-0114140142310.1007/s40122-024-00689-0Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus DysfunctionFrank Schwab0Nagy Mekhail1Kiran V. Patel2Meredith Langhorst3Robert D. Heros4Jonathan Gentile5Sherif Costandi6Gregory Moore7Christopher Gilmore8Smith Manion9Krishnan Chakravarthy10S. Craig Meyer11Justin V. Bundy12Jordan L. Tate13Rebecca Sanders14Sandeep Vaid15Oszkar Szentirmai16Johnathan Goree17Vikas V. Patel18Jeff Lehmen19Mehul J. Desai20Jason E. Pope21Anthony Giuffrida22Salim Hayek23Sohrab Singh Virk24Richard Paicius25William R. Klemme26Robert Levy27Christopher Gilligan28the RESTORE investigatorsNorthwell Health Orthopaedic Institute at Lenox HillCleveland ClinicNorthwell Health Pain Medicine, AnesthesiologyOrthoIndy HospitalSpinal DiagnosticsIndiana Spine GroupCleveland ClinicPacific Sports and SpineCenter for Clinical Research, Carolinas Pain InstituteMidwest Anesthesia AssociatesInnovative Pain Treatment SolutionsColumbia Orthopaedic GroupAugusta-Aiken Orthopedic SpecialistsSouthern Pain and SpineFreeman Institute for Pain ManagementSummit Spine & Joint CentersCleveland Clinic FloridaDepartment of Anesthesiology, University of Arkansas Medical SciencesDepartment of Orthopedic Surgery, University of ColoradoLehmen Spine CenterInternational Spine Pain & Performance CenterEvolve Restorative CenterCantor Spine Center, Paley Orthopedic and Spine InstituteDivision of Pain Medicine, University Hospitals, Cleveland Medical CenterNorthwell HealthSouthern California Spine and SportUniformed Services University of the Health SciencesAnesthesia Pain Care Consultants, LLCRobert Wood Johnson University Hospital/Rutgers Medical SchoolAbstract Introduction Many interventional strategies are commonly used to treat chronic low back pain (CLBP), though few are specifically intended to target the distinct underlying pathomechanisms causing low back pain. Restorative neurostimulation has been suggested as a specific treatment for mechanical CLBP resulting from multifidus dysfunction. In this randomized controlled trial, we report outcomes from a cohort of patients with CLBP associated with multifidus dysfunction treated with restorative neurostimulation compared to those randomized to a control group receiving optimal medical management (OMM) over 1 year. Methods RESTORE is a multicenter, open-label randomized controlled trial. Candidates were assessed for CLBP associated with multifidus dysfunction, with no indication for or history of lumbar spine surgery. Participants were randomized to either restorative neurostimulation with the ReActiv8 system or OMM. The primary endpoint was a comparison of the mean change in the Oswestry Disability Index (ODI) between the treatment and control arms at 1 year, and secondary endpoints included pain (numeric rating scale [NRS]) and health-related quality of life (EuroQol Five-Dimension [EQ-5D-5L]). Results A total of 203 patients, average age 47 years, and with an average 11-year history of low back pain, were included in the analysis. The primary endpoint was a statistically significant demonstration of a clinically relevant mean improvement in the Oswestry Disability Index (ODI) between restorative neurostimulation and OMM arms: ODI (−19.7 ± 1.4 vs. −2.9 ± 1.4; p < 0.001). Additionally, improvements in both the numeric rating scale (NRS) (−3.6 ± 0.2 vs. −0.6 ± 0.2; p < 0.001) and EuroQol Five-Dimension (EQ-5D-5L) (0.155 ± 0.012 vs. 0.008 ± 0.012; p < 0.001) were statistically and clinically significant in the restorative neurostimulation arm compared to the OMM arm. Conclusion The RESTORE trial demonstrates that restorative neurostimulation is a safe, reversible, clinically effective, and highly durable option for patients suffering with nonoperative CLBP associated with multifidus dysfunction. This demonstration of treatment superiority over OMM through 1 year is a significant milestone in addressing a major health burden and unmet clinical need. Trial Registration ClinicalTrials.gov Identifier: NCT04803214.https://doi.org/10.1007/s40122-024-00689-0Multifidus dysfunctionRestorative neurostimulationChronic low back painNeuromuscular controlPeripheral nerve stimulationNociceptive pain |
| spellingShingle | Frank Schwab Nagy Mekhail Kiran V. Patel Meredith Langhorst Robert D. Heros Jonathan Gentile Sherif Costandi Gregory Moore Christopher Gilmore Smith Manion Krishnan Chakravarthy S. Craig Meyer Justin V. Bundy Jordan L. Tate Rebecca Sanders Sandeep Vaid Oszkar Szentirmai Johnathan Goree Vikas V. Patel Jeff Lehmen Mehul J. Desai Jason E. Pope Anthony Giuffrida Salim Hayek Sohrab Singh Virk Richard Paicius William R. Klemme Robert Levy Christopher Gilligan the RESTORE investigators Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction Pain and Therapy Multifidus dysfunction Restorative neurostimulation Chronic low back pain Neuromuscular control Peripheral nerve stimulation Nociceptive pain |
| title | Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction |
| title_full | Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction |
| title_fullStr | Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction |
| title_full_unstemmed | Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction |
| title_short | Restorative Neurostimulation Therapy Compared to Optimal Medical Management: A Randomized Evaluation (RESTORE) for the Treatment of Chronic Mechanical Low Back Pain due to Multifidus Dysfunction |
| title_sort | restorative neurostimulation therapy compared to optimal medical management a randomized evaluation restore for the treatment of chronic mechanical low back pain due to multifidus dysfunction |
| topic | Multifidus dysfunction Restorative neurostimulation Chronic low back pain Neuromuscular control Peripheral nerve stimulation Nociceptive pain |
| url | https://doi.org/10.1007/s40122-024-00689-0 |
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