Manchikanti Laxmaiah, Cash Kimberly A, McManus Carla D, Pampati Vidyasagar, Abdi Salahadin
Pain Management Center of Paducah, Paducah, KY 42003, USA.
Pain Physician. 2008 Nov-Dec;11(6):833-48.
Spinal stenosis is one of the 3 most common diagnoses of low back and leg symptoms which also include disc herniation and degenerative spondylolisthesis. Spinal stenosis is a narrowing of the spinal canal with encroachment on the neural structures by surrounding the bone and soft tissue. In the United States, one of the most commonly performed interventions for managing chronic low back pain are epidural injections, including their use for spinal stenosis. However, there have not been any randomized trials and evidence is limited with regards to the effectiveness of epidural injections in managing chronic function-limiting low back and lower extremity pain secondary to lumbar spinal stenosis.
A randomized, double-blind, equivalence trial.
An interventional pain management practice, a specialty referral center, a private practice setting in the United States.
To evaluate the effectiveness of caudal epidural injections with or without steroids in providing effective and long-lasting pain relief in the management of chronic low back pain in spinal stenosis and to evaluate the differences between local anesthetic with or without steroids.
Patients were randomly assigned to one of 2 groups, with Group I patients receiving caudal epidural injections of local anesthetic (lidocaine 0.5%), whereas Group II patients received caudal epidural injections with 0.5% lidocaine 9 mL mixed with 1 mL of steroid. Randomization is being performed by computer-generated random allocation sequence by simple randomization.
Multiple outcome measures were utilized which included the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3 months, 6 months, and 12 months post-treatment. Significant pain relief was defined as 50% or more, whereas significant improvement in disability score was defined as reduction of 40% or more.
Significant pain relief (> or =50%) was demonstrated in 55% to 65% of the patients and functional status improvement with 40% reduction in ODI scores in 55% to 80% of the patients. The overall average procedures per year were 3.4 +/- 1.27 in Group I and 2.6 +/- 1.35 in Group II with an average total relief per year of 30.3 +/- 19.49 weeks in Group I and 23.1 +/- 21.36 weeks in Group II over a period of 52 weeks.
The results of this study are limited by the lack of a placebo group and a preliminary report of 20 patients in each group, even though sample was justified.
Caudal epidural injections with or without steroids may be effective in patients with chronic function-limiting low back and lower extremity pain with spinal stenosis in approximately 60% of the patients.
腰椎管狭窄症是导致腰腿痛的3种最常见诊断之一，其他两种包括椎间盘突出症和退变性腰椎滑脱。腰椎管狭窄症是指椎管狭窄，周围骨骼和软组织压迫神经结构。在美国，硬膜外注射是治疗慢性腰痛最常用的干预措施之一，包括用于治疗腰椎管狭窄症。然而，尚无任何随机试验，关于硬膜外注射治疗继发于腰椎管狭窄症的慢性功能受限性腰腿痛的有效性，证据有限。
一项随机、双盲、等效性试验。
美国一家介入性疼痛管理诊所、一家专科转诊中心、一家私人诊所。
评估尾端硬膜外注射含或不含类固醇药物在治疗腰椎管狭窄症慢性腰痛方面提供有效和持久疼痛缓解的效果，并评估含或不含类固醇的局部麻醉剂之间的差异。
患者被随机分为2组，第一组患者接受尾端硬膜外注射局部麻醉剂（0.5%利多卡因），而第二组患者接受尾端硬膜外注射9毫升0.5%利多卡因与1毫升类固醇混合的药物。通过计算机生成的随机分配序列进行简单随机化。
采用多种结果测量指标，包括数字评分量表（NRS）、Oswestry功能障碍指数2.0（ODI）、就业状况和阿片类药物摄入量，在治疗后3个月、6个月和12个月进行评估。显著的疼痛缓解定义为缓解50%或更多，而功能障碍评分的显著改善定义为降低40%或更多。
55%至65%的患者显示出显著的疼痛缓解（≥50%），55%至80%的患者功能状态改善，ODI评分降低40%。在52周的时间里，第一组每年的平均手术次数为3.4±1.27次，第二组为2.6±1.35次，第一组每年的平均总缓解时间为30.3±19.49周，第二组为23.1±21.36周。
本研究结果因缺乏安慰剂组以及每组仅20例患者的初步报告而受到限制，尽管样本量是合理的。
尾端硬膜外注射含或不含类固醇药物，对于约60%患有慢性功能受限性腰腿痛的腰椎管狭窄症患者可能有效。
