Carette S, Marcoux S, Truchon R, Grondin C, Gagnon J, Allard Y, Latulippe M
Department of Medicine, Laval University, Quebec City, Canada.
N Engl J Med. 1991 Oct 3;325(14):1002-7. doi: 10.1056/NEJM199110033251405.
Chronic low back pain is a common problem with many treatments, few of which have been rigorously evaluated. This randomized, placebo-controlled trial was designed to evaluate the efficacy of injections of corticosteroid into facet joints to treat chronic low back pain.
Patients with chronic low back pain who reported immediate relief of their pain after injections of local anesthetic into the facet joints between the fourth and fifth lumbar vertebrae and the fifth lumbar and first sacral vertebrae were randomly assigned to receive under fluoroscopic guidance injections of either methylprednisolone acetate (20 mg; n = 49) or isotonic saline (n = 48) in the same facet joints. Ninety-five patients were followed for six months and their condition assessed with scales of pain severity, back mobility, and limitation of function.
After one month, none of the outcome measures evaluating pain, functional status, and back flexion differed clinically or statistically between the two study groups. Forty-two percent of the patients who received methylprednisolone and 33 percent of those who received placebo reported marked or very marked improvement (95 percent confidence interval for the difference, -11 to 28 percentage points; P = 0.53). The results were similar after three months. At the six-month evaluation, the patients treated with methylprednisolone reported more improvement, less pain on the visual-analogue scale, and less physical disability. The differences were reduced, however, when concurrent interventions were taken into account. Moreover, only 11 patients (22 percent) in the methylprednisolone group and 5 (10 percent) in the placebo group had sustained improvement from the first month to the sixth month (95 percent confidence interval for the difference, -2 to 26; P = 0.19).
We conclude that injecting methylprednisolone acetate into the facet joints is of little value in the treatment of patients with chronic low back pain.
慢性下腰痛是一个常见问题,治疗方法众多,但很少有经过严格评估的。这项随机、安慰剂对照试验旨在评估向小关节内注射皮质类固醇治疗慢性下腰痛的疗效。
那些在向第四和第五腰椎以及第五腰椎和第一骶椎之间的小关节内注射局部麻醉剂后报告疼痛立即缓解的慢性下腰痛患者,被随机分配在荧光镜引导下于相同小关节内接受醋酸甲泼尼龙(20毫克;n = 49)或等渗盐水(n = 48)注射。95名患者被随访6个月,并用疼痛严重程度、背部活动度和功能受限量表对其病情进行评估。
1个月后,两个研究组在评估疼痛、功能状态和背部前屈的各项指标上,在临床或统计学上均无差异。接受甲泼尼龙治疗的患者中有42%、接受安慰剂治疗的患者中有33%报告有显著或非常显著的改善(差异的95%置信区间为-11至28个百分点;P = 0.53)。3个月后的结果相似。在6个月评估时,接受甲泼尼龙治疗的患者报告有更多改善、视觉模拟量表上疼痛减轻且身体残疾程度减轻。然而,当考虑到同期干预措施时,差异减小。此外,从第1个月到第6个月,甲泼尼龙组只有11名患者(22%)、安慰剂组只有5名患者(10%)持续改善(差异的95%置信区间为-2至26;P = 0.19)。
我们得出结论,向小关节内注射醋酸甲泼尼龙对慢性下腰痛患者的治疗价值不大。