Treatment of nonsurgical refractory back pain with high-frequency spinal cord stimulation at 10 kHz: 12-month results of a pragmatic, multicenter, randomized controlled trial.

Autor:	Kapural L; 1Carolina's Pain Institute, Winston-Salem, North Carolina., Jameson J; 2Axis Spine Center, Coeur d'Alene, Idaho., Johnson C; 3Midwest Pain Management Center, Overland Park., Kloster D; 4Crimson Pain Management, Overland Park, Kansas., Calodney A; 5Interventional Spine, Texas Spine and Joint Hospital, Tyler, Texas., Kosek P; 6Pain Management, Oregon Neurosurgery Specialists, Springfield, Oregon., Pilitsis J; 7Neurosurgery, Albany Medical Center, Albany, New York., Bendel M; 8Pain Management, Mayo Clinic, Rochester, Minnesota., Petersen E; 9Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, Arkansas., Wu C; 10Neurosurgery, Thomas Jefferson University Hospitals, Philadelphia, Pennsylvania., Cherry T; 11Department of Neurosurgery and Neuroscience, Kaiser Permanente, Redwood City, California., Lad SP; 12Neurosurgery, Duke University Medical Center, Durham, North Carolina., Yu C; 13Pain Research, Swedish Health Services, Seattle, Washington., Sayed D; 14Anesthesiology and Pain Medicine, University of Kansas Hospital, Kansas City, Kansas., Goree J; 9Neurosurgery, University of Arkansas for Medical Sciences, Little Rock, Arkansas., Lyons MK; 16Neurosurgery, Mayo Clinic Arizona, Phoenix, Arizona., Sack A; 14Anesthesiology and Pain Medicine, University of Kansas Hospital, Kansas City, Kansas., Bruce D; 11Department of Neurosurgery and Neuroscience, Kaiser Permanente, Redwood City, California., Rubenstein F; 15Nevro Corp., Redwood City, California; and., Province-Azalde R; 15Nevro Corp., Redwood City, California; and., Caraway D; 15Nevro Corp., Redwood City, California; and., Patel NP; 16Neurosurgery, Mayo Clinic Arizona, Phoenix, Arizona.
Jazyk:	angličtina
Zdroj:	Journal of neurosurgery. Spine [J Neurosurg Spine] 2022 Feb 11; Vol. 37 (2), pp. 188-199. Date of Electronic Publication: 2022 Feb 11 (Print Publication: 2022).
DOI:	10.3171/2021.12.SPINE211301
Abstrakt:	Objective: Spinal cord stimulation (SCS) at 10 kHz (10-kHz SCS) is a safe and effective therapy for treatment of chronic low-back pain. However, it is unclear from existing evidence whether these findings can be generalized to patients with chronic back pain that is refractory to conventional medical management (CMM) and who have no history of spine surgery and are not acceptable candidates for spine surgery. The authors have termed this condition "nonsurgical refractory back pain" (NSRBP) and conducted a multicenter, randomized controlled trial to compare CMM with and without 10-kHz SCS in this population. Methods: Patients with NSRBP, as defined above and with a spine surgeon consultation required for confirmation, were randomized 1:1 to patients undergoing CMM with and without 10-kHz SCS. CMM included nonsurgical treatment for back pain, according to physicians' best practices and clinical guidelines. Primary and secondary endpoints included the responder rate (≥ 50% pain relief), disability (Oswestry Disability Index [ODI]), global impression of change, quality of life (EQ-5D-5L), and change in daily opioid use and were analyzed 3 and 6 months after randomization. The protocol allowed for an optional crossover at 6 months for both arms, with observational follow-up over 12 months. Results: In total, 159 patients were randomized; 76 received CMM, and 69 (83.1%) of the 83 patients who were assigned to the 10-kHz SCS group received a permanent implant. At the 3-month follow-up, 80.9% of patients who received stimulation and 1.3% of those who received CMM were found to be study responders (primary outcome, ≥ 50% pain relief; p < 0.001). There was also a significant difference between the treatment groups in all secondary outcomes at 6 months (p < 0.001). In the 10-kHz SCS arm, outcomes were sustained, including a mean 10-cm visual analog scale score of 2.1 ± 2.3 and 2.1 ± 2.2 and mean ODI score of 24.1 ± 16.1 and 24.0 ± 17.0 at 6 and 12 months, respectively (p = 0.9). In the CMM arm, 74.7% (56/75) of patients met the criteria for crossover and received an implant. The crossover arm obtained a 78.2% responder rate 6 months postimplantation. Five serious adverse events occurred (procedure-related, of 125 total permanent implants), all of which resolved without sequelae. Conclusions: The study results, which included follow-up over 12 months, provide important insights into the durability of 10-kHz SCS therapy with respect to chronic refractory back pain, physical function, quality of life, and opioid use, informing the current clinical practice for pain management in patients with NSRBP.
Databáze:	MEDLINE
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