Comparing Conventional Medical Management to Spinal Cord Stimulation for the Treatment of Low Back Pain in a Cohort of DISTINCT RCT Patients.

Aim: Low Back Pain (LBP) is a prevalent condition. Spinal cord stimulation (SCS) has emerged as a more effective, long-term treatment compared to conventional medical management (CMM). The DISTINCT study enrolled and randomized chronic LBP patients with no indication of traditional spine surgery. This analysis focuses comparing study outcomes on patients initially randomized to receive CMM treatment and subsequently crossed over to SCS after 6 months.
Purpose: To compare the therapeutic effectiveness and cost-efficiency of passive recharge burst SCS to CMM.
Patients and Methods: A total of 269 patients were enrolled with 162 randomly assigned to SCS and 107 to CMM. The DISTINCT study design allowed a crossover to the alternative treatment arm after 6 months. Patients underwent a trial and received a permanent implant if they reported ≥50% pain reduction. Outcome analysis included pain (NRS), disability (ODI), catastrophizing (PCS), quality of life (PROMIS-29) and health care utilization.
Results: Seventy out of eighty-one patients opted to cross over to trial SCS at 6M with 94% (66/70) undergoing a trial. Among those, 88% (58/66) reported a ≥50% or more pain relief and 55 received a permanent implant. At 12M visit, 71.4% reported a ≥50% pain improvement sustained at the 18M visit, with 24.5% (12/49) indicating a ≥80% improvement. Disability reductions (79% meeting the minimally important difference of a 13-point decrease), decreased catastrophizing, and significant improvements in all PROMIS-29 domains were noted. Furthermore, 42% of the patients reported decreased or discontinued opioid usage. Clinical benefits at the 12M visit were sustained through the 18M visit accompanied by a significant reduction in healthcare utilization and a $1214 cost savings.
Conclusion: SCS demonstrates superior, long-term performance and safety outcomes compared to CMM therapy in LBP patients who received both CMM and SCS therapy. Additionally, SCS patients experienced reduced healthcare resource utilization and lower costs compared to those receiving CMM.
Competing Interests: Timothy Deer has consulting agreements with Abbott, Saluda, Nalu, and SPR Therapeutics and has received grant support from Vertos, SpineThera, Mainstay, Cornerloc, Boston Scientific, PainTeq, Spinal Simplicity, Biotronik, Aurora, Nervonik, Saluda, Nalu, and SPR Therapeutics. Timothy Deer has stocks or stock options with Saluda, Nalu, and SPR Therapeutics. Jacqueline Weisbein has consulting agreements with Abbott, Vertos, Saluda, Biotronik and SI Bone. She has received payment or honoraria for lectures, presentations, speaking bureaus or educational events from Abbott and Saluda. Jacqueline Weisbein has received grants from Abbvie, Medtronic, Saluda, and SI Bone. Udoka Okaro is an employee of Abbott. Denis Patterson has received grant/research support from Abbott, Flowonix, Nevro, Saluda, Vertiflex. Denis Patterson has consulting agreements with Aurora Spine, Abbvie, Nevro, Abbott, AIS, Allergan, Amgen, CornerLoc, Flowonix, Lundbeck, PainTEQ, Pajunk Medical, Saluda, Spark Biomedical, Vertos and has received honoraria from Abbott, Allergan, Amgen, Vertos, CornerLoc, Lundbeck, PainTEQ and Saluda. He also has stock or stock options with CornerLoc. Ajay Antony has consulting agreements with Abbott, Boston Scientific, Saluda, Vertos, PainTEQ, and Avanos and serves on an advisory board for Boston Scientific, Abbott, and Saluda. Patrick Buchanan reports consulting fees from Abbott, Saluda and PainTEQ. Chris Gilligan reports consulting fees from Biotronik, Mainstay Medical, Persica, Saluda, and Iliad Lifesciences and stock or stock options from Mainstay Medical. He also reports to the Board of Directors for International Neuromodulation Society and Editor-in-Chief for Pain Practice. Robert Heros reports consulting fees from Abbott, Mainstay Medical, Saluda Medical, Biotronik, Ethos Laboratories and Boston Scientific and support for attending meetings from Mainstay Medical and participated on a data safety monitoring board/advisory board for Biotronik. James J. Yue reports consulting income and grant support from Abbott. The other authors report no conflicts of interest in this work.
(© 2024 Deer et al.)