Durable patient-reported outcomes following 60-day percutaneous peripheral nerve stimulation (PNS) of the medial branch nerves.

Autor:	Gilmore CA; Center for Clinical Research, Carolinas Pain Institute, Winston-Salem, NC, USA., Deer TR; Spine & Nerve Centers of the Virginias, Charleston, WV, USA., Desai MJ; International Spine, Pain & Performance Center, Washington, DC, USA., Hopkins TJ; Duke University, Durham, NC, USA., Li S; Premier Pain Centers, Shrewsbury, NJ, USA., DePalma MJ; Virginia iSpine Physicians, Richmond, VA, USA., Cohen SP; Johns Hopkins School of Medicine, Baltimore, MD, USA., McGee MJ; SPR Therapeutics, Inc, Cleveland, OH, USA., Boggs JW; SPR Therapeutics, Inc, Cleveland, OH, USA.
Jazyk:	angličtina
Zdroj:	Interventional pain medicine [Interv Pain Med] 2023 Mar 13; Vol. 2 (1), pp. 100243. Date of Electronic Publication: 2023 Mar 13 (Print Publication: 2023).
DOI:	10.1016/j.inpm.2023.100243
Abstrakt:	Background: Chronic low back pain (CLBP) is often associated with clinical evidence of central nervous system sensitization and finding a clear source of nociceptive input can be challenging. Conventional therapies targeting peripheral spinal pain structures can fail to address centrally-mediated, underlying causes of pain. Sixty-day percutaneous peripheral nerve stimulation (PNS) applied to the lumbar medial branch nerves is a non-surgical, non-opioid treatment that may restore the balance of peripheral inputs to the central nervous system and reverse maladaptive changes in central pain processing. As a minimally invasive, non-destructive treatment, percutaneous PNS was designed to be used earlier in the treatment continuum than radiofrequency ablation or permanently-implanted neurostimulation systems. Objective: The objective of this clinical trial was to characterize the durability of responses to medial branch PNS in a prospective multicenter case series study of CLBP patients recalcitrant to multiple non-surgical treatments. Design: Prospective, multicenter clinical trial. Population: Adults with CLBP without radicular leg pain who had previously failed multiple types of conventional treatments. Intervention: Sixty-day percutaneous PNS applied to the lumbar medial branch nerves. Methods: Percutaneous PNS leads were implanted under image guidance (ultrasound and/or fluoroscopy) and treatment was applied for up to 60 days, after which the leads were removed. Participants were followed through 14 months (12 months after the 2-month PNS treatment). Prospectively-defined endpoints included assessments of pain intensity, disability, pain interference, health-related quality of life, depression, and patient global impression of change. Results: Treatment of CLBP with 60-day percutaneous PNS treatment produced clinically meaningful improvements in average pain intensity, disability, and/or pain interference for a majority of participants through the entire 14 month follow up period without requiring permanent system implantation. The proportion of participants experiencing clinically meaningful improvement in at least one outcome (pain intensiy, disability, pain interference) with PNS was 91% after 2 months, 79% at 5 months, 73% at 8 months, 75% at 11 months, and 77% at 14 months. There were no serious or unanticipated study-related adverse events. Conclusion: This prospective multicenter clinical trial demonstrates the clinical utility of percutaneous PNS when applied to the medial branch nerves for the treatment of chronic low back pain recalcitrant to non-surgical treatments. Given the minimally invasive nature of percutaneous PNS and the significant benefits experienced by participants, percutaneous PNS provides a safe and effective first-line neuromodulation treatment for patients with CLBP that may obviate the need for neuroablative procedures or permanent neurostimulation system implantation. Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Christopher Gilmore, Mehul Desai, Sean Li, Michael DePalma, Timothy Deer, and Steven Cohen reports financial support was provided by SPR Therapeutics Inc. Christopher Gilmore, Mehul Desai, Sean Li, Michael DePalma, Timothy Deer, and Steven Cohen reports a relationship with SPR Therapeutics Inc that includes: consulting or advisory, speaking and lecture fees, and travel reimbursement. Joseph Boggs and Meredith McGee has patent issued to SPR Therapeutics, Inc. Drs Gilmore, Desai, Hopkins, Li, DePalma, and Deer are physician investigators with clinical research sponsored by SPR Therapeutics. Drs Gilmore, Desai, Li, Deer, and Cohen are consultants for SPR, and Drs Desai and Deer have equity ownership in SPR Therapeutics. Drs McGee and Boggs are employees of SPR Therapeutics with equity ownership. (© 2023 The Authors.)
Databáze:	MEDLINE
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