UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
■这个前景,多中心,随机化,选择6个月交叉的研究纳入了不适合进行腰椎手术的患者.主要和次要终点评估了下腰痛强度(NRS)的改善,背痛相关残疾(ODI),疼痛灾难化(PCS),和医疗保健利用。在30个美国研究地点,患者被随机分配到SCS治疗或CMM。
■SCS手臂报告了85.3%的NRS响应率(≥50%的减少),而CMM手臂为6.2%(5/81)。在6M主终点之后,SCS患者选择继续接受指定的治疗,66.2%(49/74)的CMM患者选择试验SCS(交叉)。在12M随访中,SCS和交叉患者报告了78.6%和71.4%的NRS应答率。次要结果表明ODI有显著改善,PCS,并降低医疗保健利用率。报告了6起严重不良事件,并且没有后遗症。
■DISTINCT无矫正手术指征的慢性下腰痛患者对爆发性SCS治疗的持续反应长达12个月。交叉到SCS臂的CMM患者在6个月后报告了明显的改善。该数据主张及时考虑对保守治疗无反应的患者的SCS治疗。