2001 Volvo Award winner in clinical studies:: Lumbar fusion versus nonsurgical treatment for chronic low back pain -: A multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group
2001 Volvo Award winner in clinical studies:: Lumbar fusion versus nonsurgical treatment for chronic low back pain -: A multicenter randomized controlled trial from the Swedish Lumbar Spine Study Group
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DOI：
10.1097/00007632-200112010-00002
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发表时间：
2001-12-01
期刊：
影响因子：
3
通讯作者：
Nordwall, A
中科院分区：
文献类型：
--
作者：
Fritzell, P;Hägg, O;Nordwall, A
研究设计：一项由独立观察者进行为期2年随访的随机对照多中心研究。
目的：确定在患有严重慢性下腰痛（CLBP）的患者中，与非手术治疗相比，下腰椎融合是否能更有效地减轻疼痛和减少残疾。
背景资料概述：关于CLBP患者融合手术后的报道结果差异很大，在缺乏随机对照研究的情况下，治疗效果的证据薄弱。
患者和方法：1992年至1998年期间，共有294名被转诊至19个脊柱中心的患者被随机盲法分为4个治疗组。年龄在25 - 65岁之间、患有CLBP至少2年且在L4 - L5、L5 - S1或两者都有椎间盘退变影像学证据的患者有资格参与研究。手术组（n = 222）包括3种不同的融合技术，在本研究中未单独分析。非手术组（n = 72）的患者接受不同种类的物理治疗。手术组男性占49.5%，平均年龄为43岁。非手术组相应的数据为48.6%和44岁。患者平均分别患有下腰痛7.8年和8.5年，因腰痛平均请病假3.2年和2.9年。使用视觉模拟量表（VAS）测量疼痛。使用奥斯威斯特里下腰痛问卷、米勒评分和一般功能评分（GFS）测量残疾。使用宗氏抑郁量表测量抑郁症状。由患者和独立观察者评估总体结果。使用瑞典社会保险记录评估工作残疾。根据意向性治疗原则，改变分组的患者被纳入显著性分析。
结果：在2年随访时，294名患者中的289名（98%），包括25名改变分组的患者接受了检查。手术组的腰痛减轻了33%（从64降至43），而非手术组减轻了7%（从63降至58）（P = 0.0002）。疼痛在最初6个月改善最明显，然后逐渐恶化。根据奥斯威斯特里量表，残疾在手术组减少了25%（从47降至36），而非手术患者中减少了6%（从48降至46）（P = 0.015）；根据米勒量表，减少了28%（从64降至46），而非手术组减少了8%（从66降至60）（P = 0.004）；根据GFS量表，减少了31%（从49降至34），而非手术组减少了4%（从48降至46）（P = 0.005）。根据宗氏量表，手术组的抑郁症状减少了20%（从39降至31），而非手术组减少了7%（从39降至36）（P = 0.123）。在手术组中，63%（122/195）的患者认为自己“好得多”或“更好”，而非手术组中这一比例为29%（18/62）（P未给出完整内容）
Study Design. A randomized controlled multicenter study with a 2-year follow-up by an independent observer.Objectives. To determine whether fusion of the lower lumbar spine could reduce pain and diminish disability more effectively when compared with nonsurgical treatment in patients with severe chronic low back pain (CLBP).Summary of Background Data. The reported results after fusion surgery on patients with CLBP vary considerably, and the evidence of treatment efficacy is weak in the absence of randomized controlled studies.Patients and Methods. A total of 294 patients referred to 19 spinal centers from 1992 through 1998 were randomized blindly into four treatment groups. Patients aged 25-65 years with CLBP for at least 2 years and with radiologic evidence of disc degeneration at L4-L5, L5-S1, or both were eligible to participate in the study. The surgical group (n=222) included three different fusion techniques, not analyzed separately in this study. Patients in the nonsurgical group (n=72) were treated with different kinds of physical therapy. The surgical group comprised 49.5% men, and the mean age was 43 years. The corresponding figures for the nonsurgical group were 48.6% and 44 years, The patients had suffered from low back pain for a mean of 7.8 and 8.5 years and been on sick leave due to back pain for a mean of 3.2 and 2.9 years, respectively: The Visual Analogue Scale (VAS) was used to measure pain. The Oswestry Low Back Pain Questionnaire, the Million Score and the General Function Score (GFS) were used to measure disability. The Zung Depression Scale was used to measure depressive symptoms. The overall result was assessed by the patient and by an independent observer. Records from the Swedish Social Insurance were used to evaluate work disability. Patients who changed groups were included in the analyses of significance according to the intention-to-treat principle.Results. At the 2-year follow-up 289 of 294 (98%) patients, including 25 who had changed groups, were examined. Back pain was reduced in the surgical group by 33% (64 to 43), compared with 7% (63 to 58) in the nonsurgical group (P=0.0002). Pain improved most during the first 6 months and then gradually deteriorated. Disability according to Oswestry was reduced by 25% (47 to 36) compared with 6% (48 to 46) among nonsurgical patients (P=0.015), according to Million by 28% (64 to 46) compared with 8% (66 to 60) (P=0.004); and according-toGFS by 31% (49 to 34) compared with 4% (48 to 46) (P=0.005). The depressive symptoms, according to Zung, were reduced by 20% (39 to 31) in the surgical group compared with 7% (39 to 36) in the nonsurgical group (P=0.123). In the surgical group 63% (122/195) rated themselves as "much better" or "better" compared with 29% (18/62) in the nonsurgical group (P