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经皮粘连松解术与硬膜外类固醇注射治疗腰椎术后综合征的疗效比较:一项随机、等效对照试验。

A comparative effectiveness evaluation of percutaneous adhesiolysis and epidural steroid injections in managing lumbar post surgery syndrome: a randomized, equivalence controlled trial.

机构信息

Pain Management Center of Paducah, Paducah, KY, USA.

出版信息

Pain Physician. 2009 Nov-Dec;12(6):E355-68.

PMID:19935992
Abstract

BACKGROUND

Speculated causes of post lumbar surgery syndrome include epidural fibrosis, acquired stenosis, and facet joint pain among other causes. Even though fluoroscopically directed caudal epidural injections and facet joint interventions are effective in some patients, others continue to suffer with chronic persistent pain. Percutaneous adhesiolysis with target delivery of medications has been demonstrated to be effective in these patients. However, the evidence for percutaneous adhesiolysis in managing post surgery syndrome has been questioned, coupled with a paucity of controlled trials.

STUDY DESIGN

A randomized, equivalence, controlled trial.

SETTING

An interventional pain management practice, a specialty referral center, a private practice setting in the United States.

OBJECTIVES

To evaluate the effectiveness of percutaneous epidural adhesiolysis in patients with chronic low back and lower extremity pain in post surgery syndrome and compare with fluoroscopically directed caudal epidural steroid injections.

METHODS

Patients were randomly assigned to one of 2 groups: Group I (60 patients) receiving caudal epidural injections with catheterization up to S3 with local anesthetic, steroids, and 0.9% sodium chloride solution serving as the control group, and Group II (60 patients) receiving percutaneous adhesiolysis with targeted delivery of lidocaine, 10% hypertonic sodium chloride solution, and non-particulate Betamethasone serving as the intervention group. Randomization was performed by computer-generated random allocation sequence by simple randomization.

OUTCOMES ASSESSMENT

Multiple outcome measures were utilized including the Numeric Rating Scale (NRS), the Oswestry Disability Index 2.0 (ODI), employment status, and opioid intake with assessment at 3, 6, and 12 months post treatment. Significant pain relief was described as 50% or more, whereas significant improvement in the disability score was defined as a reduction of 40% or more.

RESULTS

Significant pain relief (>or= 50%) and functional status improvement was recorded in 73% of patients in Group II versus 12% in Group I (P < 0.001). The average procedures per year were 3.5 with an average total relief of 42 out of 52 weeks in Group II and 2.2 procedures with total relief per year of 13 weeks in Group I (P < 0.001).

LIMITATIONS

The results of this study are limited by potentially inadequate double blinding, by the lack of a placebo group, and the preliminary report of one-year follow-up.

CONCLUSIONS

Percutaneous adhesiolysis in chronic function-limiting, recalcitrant low back pain in post lumbar surgery syndrome demonstrated effectiveness in 73% of the patients.

摘要

背景

腰椎手术后综合征的推测病因包括硬膜外纤维化、获得性狭窄和小关节疼痛等。虽然经皮骶管硬膜外注射和小关节介入治疗对一些患者有效,但其他患者仍持续遭受慢性持续性疼痛。经皮粘连松解术联合靶向药物治疗已被证明对这些患者有效。然而,经皮粘连松解术治疗术后综合征的证据受到质疑,且缺乏对照试验。

研究设计

一项随机、等效、对照试验。

设置

美国的介入性疼痛管理实践、专科转诊中心和私人执业环境。

目的

评估经皮硬膜外粘连松解术治疗慢性腰痛和下肢疼痛术后综合征患者的有效性,并与经皮骶管硬膜外类固醇注射进行比较。

方法

患者随机分为两组:I 组(60 例)接受骶管硬膜外注射,导管插入至 S3 水平,给予局部麻醉、类固醇和 0.9%氯化钠溶液作为对照组;II 组(60 例)接受经皮粘连松解术,靶向给予利多卡因、10%高渗氯化钠溶液和非颗粒性倍他米松作为干预组。随机化通过简单随机化的计算机生成随机分配序列进行。

结局评估

使用多种结局评估指标,包括数字评分量表(NRS)、Oswestry 残疾指数 2.0(ODI)、就业状况和阿片类药物摄入,治疗后 3、6 和 12 个月进行评估。显著疼痛缓解定义为 50%或更多,而残疾评分显著改善定义为减少 40%或更多。

结果

I 组有 12%的患者(n=7)出现 50%或以上的显著疼痛缓解,而 II 组有 73%的患者(n=44)出现显著疼痛缓解(P<0.001)。II 组患者的平均手术次数为 3.5 次,每年的平均总缓解时间为 42 周,而 I 组患者的平均手术次数为 2.2 次,每年的平均总缓解时间为 13 周(P<0.001)。

局限性

本研究结果受到潜在的不充分双盲、缺乏安慰剂组和为期一年的初步随访的限制。

结论

在腰椎手术后综合征引起的慢性功能受限、顽固性腰痛患者中,经皮粘连松解术的有效性为 73%。

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