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一项随机、安慰剂对照研究,评估外侧支神经切断术治疗慢性骶髂关节疼痛的疗效。

A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain.

机构信息

Advanced Pain Management, Green Bay, Wisconsin 54311, USA.

出版信息

Pain Med. 2012 Mar;13(3):383-98. doi: 10.1111/j.1526-4637.2012.01328.x. Epub 2012 Feb 2.

Abstract

OBJECTIVE

The objective of this study was to compare the efficacy of lateral branch neurotomy using cooled radiofrequency to a sham intervention for sacroiliac joint pain.

DESIGN

Fifty-one subjects were randomized on a 2:1 basis to lateral branch neurotomy and sham groups, respectively. Follow-ups were conducted at 1, 3, 6, and 9 months. Subjects and coordinators were blinded to randomization until 3 months. Sham subjects were allowed to crossover to lateral branch neurotomy after 3 months.

SUBJECTS

Subjects 18-88 years of age had chronic (>6 months) axial back pain and positive response to dual lateral branch blocks.

INTERVENTIONS

Lateral branch neurotomy involved the use of cooled radiofrequency electrodes to ablate the S1-S3 lateral branches and the L5 dorsal ramus. The sham procedure was identical to the active treatment, except that radiofrequency energy was not delivered.

OUTCOME MEASURES

The principal outcome measures were pain (numerical rating scale, SF-36BP), physical function (SF-36PF), disability (Oswestry disability index), quality of life (assessment of quality of life), and treatment success.

RESULTS

Statistically significant changes in pain, physical function, disability, and quality of life were found at 3-month follow-up, with all changes favoring the lateral branch neurotomy group. At 3-month follow-up, 47% of treated patients and 12% of sham subjects achieved treatment success. At 6 and 9 months, respectively, 38% and 59% of treated subjects achieved treatment success.

CONCLUSIONS

The treatment group showed significant improvements in pain, disability, physical function, and quality of life as compared with the sham group. The duration and magnitude of relief was consistent with previous studies, with current results showing benefits extending beyond 9 months.

摘要

目的

本研究旨在比较使用冷却射频进行侧支神经切断术与假手术治疗骶髂关节疼痛的疗效。

设计

51 名受试者按 2:1 的比例随机分为侧支神经切断术组和假手术组,分别进行随访。随访时间为 1、3、6 和 9 个月。受试者和协调员在 3 个月前对随机分组情况保持盲法,3 个月后假手术组允许交叉至侧支神经切断术组。

受试者

18-88 岁的受试者患有慢性(>6 个月)轴性背痛,对双侧侧支阻滞有阳性反应。

干预措施

侧支神经切断术涉及使用冷却射频电极消融 S1-S3 侧支和 L5 背侧支。假手术程序与主动治疗相同,只是不提供射频能量。

结果测量

主要结果测量为疼痛(数字评分量表、SF-36BP)、身体功能(SF-36PF)、残疾(Oswestry 残疾指数)、生活质量(生活质量评估)和治疗成功。

结果

在 3 个月的随访中,发现疼痛、身体功能、残疾和生活质量均有统计学意义的变化,所有变化均有利于侧支神经切断术组。在 3 个月的随访中,47%的治疗患者和 12%的假手术组达到治疗成功。分别在 6 个月和 9 个月时,治疗组的 38%和 59%达到治疗成功。

结论

与假手术组相比,治疗组在疼痛、残疾、身体功能和生活质量方面均有显著改善。缓解的持续时间和程度与之前的研究一致,目前的结果显示疗效可延长至 9 个月以上。

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