PDF(Pubmed)
Abstract：
UNASSIGNED: 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.
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.
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.
摘要：
■下腰痛（LBP）是一种非常普遍的，影响数百万人的残疾状况。具有可识别的解剖疼痛发生器并导致神经性下肢症状的患者通常会接受脊柱手术，但是许多患者缺乏可识别的和/或手术矫正的病理学。非手术治疗方案通常无法提供持续的缓解。脊髓刺激（SCS）有时用于治疗这些患者，但是缺乏一级证据限制了其广泛使用和保险范围。DISTINCTRCT研究评估了被动充电爆发性SCS与传统医学治疗（CMM）相比在缓解慢性，难治性轴向下腰痛。
■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。
■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。
