Khot Abhay, Bowditch Mark, Powell John, Sharp David
Department of Trauma and Orthopaedics, Ipswich Hospital, Ipswich, UK.
Spine (Phila Pa 1976). 2004 Apr 15;29(8):833-6; discussion 837. doi: 10.1097/00007632-200404150-00002.
A prospective randomized study of the therapeutic effect of intradiscal steroid injection compared to a saline placebo.
To determine whether intradiscal steroid injection influences the clinical outcome at 1 year in patients with chronic low back pain of discogenic origin.
Steroids have been used empirically in the treatment of back pain. They have been used in the epidural space and around nerve roots and have been used as an alternative to chymopapain within the disc. Previous studies have, however, shown variable results.
A total of 120 patients with chronic low back pain of discogenic origin were enrolled in the study. At discography, if they had concordant pain, they were randomized to injection of normal saline or methylprednisolone into the disc space. These patients were prospectively followed up for 12 months, and they were asked to report pain according to a visual analogue score and their Oswestry Disability Index was recorded. The primary outcome measure was determined as a percentage change in disability, and the results were analyzed using independent samples t test. The secondary outcome measure was a change in the pain score, and this was analyzed using the Mann-Whitney U test.
There was no significant difference in the primary outcome between the two groups (P = 0.71). The steroid group had a mean change of 2.28 (SE 2.49) in percentage disability, while the saline group had a mean change of 3.42 (SE 1.79). With respect to the change in pain score, there was no significant difference between the two groups (P = 0.72). Those patients who had saline injection had a median change in pain score of 0 (interquartile range -1 to 1), whereas those given steroid treatment had a median change in pain score of 0 (interquartile range -0.25 to 1).
This study demonstrates that intradiscal steroid injections do not improve the clinical outcome in patients with discogenic back pain compared with placebo.
一项前瞻性随机研究,比较椎间盘内注射类固醇与生理盐水安慰剂的治疗效果。
确定椎间盘内注射类固醇对椎间盘源性慢性下腰痛患者1年时临床结局的影响。
类固醇已被经验性地用于治疗背痛。它们被用于硬膜外间隙和神经根周围,也被用作椎间盘内木瓜凝乳蛋白酶的替代品。然而,先前的研究结果各不相同。
共纳入120例椎间盘源性慢性下腰痛患者。在椎间盘造影时,如果他们有一致性疼痛,则被随机分为向椎间盘间隙注射生理盐水或甲基泼尼松龙。对这些患者进行前瞻性随访12个月,并要求他们根据视觉模拟评分报告疼痛情况,同时记录其Oswestry功能障碍指数。主要结局指标确定为功能障碍的百分比变化,并使用独立样本t检验分析结果。次要结局指标为疼痛评分的变化,使用Mann-Whitney U检验进行分析。
两组的主要结局无显著差异(P = 0.71)。类固醇组功能障碍百分比的平均变化为2.28(标准误2.49),而生理盐水组为3.42(标准误1.79)。关于疼痛评分的变化,两组之间无显著差异(P = 0.72)。接受生理盐水注射的患者疼痛评分的中位数变化为0(四分位间距-1至1),而接受类固醇治疗的患者疼痛评分的中位数变化为0(四分位间距-0.25至1)。
本研究表明,与安慰剂相比,椎间盘内注射类固醇并不能改善椎间盘源性背痛患者的临床结局。