TY - JOUR
T1 - Surgical treatment of refractory low back pain using implanted BurstDR spinal cord stimulation (SCS) in a cohort of patients without options for corrective surgery
T2 - Findings and results from the DISTINCT study, a prospective randomized multi-center-controlled trial
AU - Yue, James J.
AU - Gilligan, Christopher J.
AU - Falowski, Steven
AU - Jameson, Jessica
AU - Desai, Mehul J.
AU - Moeschler, Susan
AU - Pilitsis, Julie
AU - Heros, Robert
AU - Tavel, Edward
AU - Wahezi, Sayed
AU - Funk, Robert
AU - Buchanan, Patrick
AU - Christopher, Anne
AU - Weisbein, Jacqueline
AU - Patterson, Denis
AU - Levy, Robert
AU - Antony, Ajay
AU - Miller, Nathan
AU - Scarfo, Keith
AU - Kreiner, Scott
AU - Wilson, Derron
AU - Lim, Chi
AU - Braun, Edward
AU - Dickerson, David
AU - Duncan, Jonathan
AU - Xu, Jijun
AU - Candido, Kenneth
AU - Mohab, Ibrahim
AU - Michael, Fishell
AU - Blomme, Bram
AU - Okaro, Udoka
AU - Deer, Timothy
N1 - Publisher Copyright:
© 2024 The Author(s)
PY - 2024/9
Y1 - 2024/9
N2 - Background: Low back pain (LBP) is a highly prevalent, disabling condition affecting millions of people. Patients with an identifiable anatomic pain generator and resulting neuropathic lower extremity symptoms often undergo spine surgery, but many patients lack identifiable and/or surgically corrective pathology. Nonoperative treatment options often fail to provide sustained relief. Spinal cord stimulation (SCS) is sometimes used to treat these patients, but the lack of level 1 evidence limits its widespread use and insurance coverage. The DISTINCT RCT study evaluates the efficacy of passive recharge burst SCS compared to conventional medical treatment (CMM) in alleviating chronic, refractory axial low back pain. Methods: This prospective, multicenter, randomized, study with an optional 6-month crossover involved patients who were not candidates for lumbar spine surgery. The primary and secondary endpoints evaluated improvements in low back pain intensity (NRS), back pain-related disability (ODI), pain catastrophizing (PCS), and healthcare utilization. Patients were randomized to SCS therapy or CMM at 30 US study sites. Results: The SCS arm reported an 85.3% NRS responder rate (≥ 50% reduction) compared to 6.2% (5/81) in the CMM arm. After the 6M primary endpoint, SCS patients elected to remain on assigned therapy and 66.2% (49/74) of CMM patients chose to trial SCS (crossover). At the 12M follow-up, SCS and crossover patients reported 78.6% and 71.4% NRS responder rates. Secondary outcomes indicated significant improvements in ODI, PCS, and reduced healthcare utilization. Six serious adverse events were reported and resolved without sequelae. Conclusion: DISTINCT chronic low back pain patients with no indication for corrective surgery experienced a significant and sustained response to burst SCS therapy for up to 12 months. CMM patients who crossed over to the SCS arm reported profound improvements after 6 months. This data advocates for a timely consideration of SCS therapy in patients unresponsive to conservative therapy.
AB - Background: Low back pain (LBP) is a highly prevalent, disabling condition affecting millions of people. Patients with an identifiable anatomic pain generator and resulting neuropathic lower extremity symptoms often undergo spine surgery, but many patients lack identifiable and/or surgically corrective pathology. Nonoperative treatment options often fail to provide sustained relief. Spinal cord stimulation (SCS) is sometimes used to treat these patients, but the lack of level 1 evidence limits its widespread use and insurance coverage. The DISTINCT RCT study evaluates the efficacy of passive recharge burst SCS compared to conventional medical treatment (CMM) in alleviating chronic, refractory axial low back pain. Methods: This prospective, multicenter, randomized, study with an optional 6-month crossover involved patients who were not candidates for lumbar spine surgery. The primary and secondary endpoints evaluated improvements in low back pain intensity (NRS), back pain-related disability (ODI), pain catastrophizing (PCS), and healthcare utilization. Patients were randomized to SCS therapy or CMM at 30 US study sites. Results: The SCS arm reported an 85.3% NRS responder rate (≥ 50% reduction) compared to 6.2% (5/81) in the CMM arm. After the 6M primary endpoint, SCS patients elected to remain on assigned therapy and 66.2% (49/74) of CMM patients chose to trial SCS (crossover). At the 12M follow-up, SCS and crossover patients reported 78.6% and 71.4% NRS responder rates. Secondary outcomes indicated significant improvements in ODI, PCS, and reduced healthcare utilization. Six serious adverse events were reported and resolved without sequelae. Conclusion: DISTINCT chronic low back pain patients with no indication for corrective surgery experienced a significant and sustained response to burst SCS therapy for up to 12 months. CMM patients who crossed over to the SCS arm reported profound improvements after 6 months. This data advocates for a timely consideration of SCS therapy in patients unresponsive to conservative therapy.
KW - BurstDR
KW - Chronic low back pain burst
KW - DISTINCT RCT
KW - Nonsurgical Low back pain
KW - Passive recharge burst
KW - SCS
UR - http://www.scopus.com/inward/record.url?scp=85199042224&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85199042224&partnerID=8YFLogxK
U2 - 10.1016/j.xnsj.2024.100508
DO - 10.1016/j.xnsj.2024.100508
M3 - Article
AN - SCOPUS:85199042224
SN - 2666-5484
VL - 19
JO - North American Spine Society Journal
JF - North American Spine Society Journal
M1 - 100508
ER -