Bailey Christopher S, Glennie Andrew, Rasoulinejad Parham, Kanawati Andrew, Taylor David, Sequeira Keith, Miller Thomas, Watson Jim, Rosedale Richard, Bailey Stewart I, Gurr Kevin R, Siddiqi Fawaz, Urquhart Jennifer C
Department of Surgery, London Health Sciences Centre, London, Ontario, Canada.
Schulich School of Medicine and Dentistry, Western University, London, Ontario, Canada.
J Bone Joint Surg Am. 2021 Dec 1;103(23):2161-2169. doi: 10.2106/JBJS.21.00448. Epub 2021 Oct 12.
Randomized controlled trials evaluating acute sciatica have not demonstrated prolonged improvements in terms of patient-reported pain and function. For chronic sciatica, however, microdiscectomy has been found to be superior at 1 year. Whether this effect persists during the second year is not known. The purpose of the present study was to report the 2-year outcomes following lumbar microdiscectomy as compared with standardized nonoperative care for the treatment of chronic sciatica resulting from a lumbar disc herniation.
The present study is a secondary analysis of a previously reported randomized controlled trial with extension to 2 years of follow-up. Patients with radiculopathy for 4 to 12 months resulting from an L4-L5 or L5-S1 disc herniation were randomized to microdiscectomy or 6 months of nonoperative care followed by surgery if needed. Intention-to-treat analysis was performed at 2 years for the primary outcome (the intensity of leg pain) (range of possible scores, 0 [no pain] to 10 [worst pain]) as well as for secondary outcomes (including the Oswestry Disability Index score, the intensity of back pain, and quality of life).
One hundred and twenty-eight patients were randomized in the present study. Twenty-four (38%) of the 64 patients who had been randomized to nonoperative care crossed over to surgical treatment by 2 years following enrollment. At the 2-year time point, the follow-up rate was approximately 70%. At 2 years, the operative group had less leg pain than the nonoperative group (mean, 2.8 ± 0.4 compared with 4.2 ± 0.4; treatment effect, 1.3 [95% confidence interval, 0.3 to 2.4]). The treatment effect favored surgery for all secondary outcome measures at 6 months and 1 year and for back pain intensity and physical function at 2 years.
At 2 years, the present study showed that microdiscectomy was superior to nonoperative care for the treatment of chronic sciatica resulting from an L4-L5 or L5-S1 disc herniation. However, the difference between the groups did not surpass the minimal clinically important difference at 2 years as was reached at earlier follow-up points, likely as the result of patients crossing over from nonoperative to operative treatment.
Therapeutic Level II . See Instructions for Authors for a complete description of levels of evidence.
评估急性坐骨神经痛的随机对照试验并未显示出患者报告的疼痛和功能方面有长期改善。然而，对于慢性坐骨神经痛，已发现显微椎间盘切除术在1年时效果更佳。这种效果在第二年是否持续尚不清楚。本研究的目的是报告腰椎显微椎间盘切除术与标准化非手术治疗相比，治疗腰椎间盘突出症所致慢性坐骨神经痛的2年结局。
本研究是对先前报道的随机对照试验的二次分析，随访期延长至2年。因L4-L5或L5-S1椎间盘突出导致神经根病4至12个月的患者被随机分为显微椎间盘切除术组或6个月非手术治疗组，必要时再行手术。对主要结局（腿痛强度）（可能得分范围为0[无疼痛]至10[最严重疼痛]）以及次要结局（包括奥斯维斯特里功能障碍指数评分、背痛强度和生活质量）在2年时进行意向性分析。
本研究中128例患者被随机分组。64例随机分配至非手术治疗组的患者中，有24例（38%）在入组后2年内转而接受手术治疗。在2年时间点，随访率约为70%。在2年时，手术组的腿痛比非手术组轻（平均值分别为2.8±0.4和4.2±0.4；治疗效果为1.3[95%置信区间为0.3至2.4]）。对于所有次要结局指标，在6个月和1年时治疗效果有利于手术，在2年时对于背痛强度和身体功能也是如此。
在2年时，本研究表明显微椎间盘切除术在治疗L4-L5或L5-S1椎间盘突出所致慢性坐骨神经痛方面优于非手术治疗。然而，两组之间的差异在2年时并未超过早期随访点所达到的最小临床重要差异，这可能是由于患者从非手术治疗转为手术治疗的结果。
治疗性II级。有关证据水平的完整描述，请参阅作者须知。
