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CT 引导下脉冲射频联合激素注射治疗腰椎间盘突出症坐骨神经痛:一项随机试验。

CT-guided Pulsed Radiofrequency Combined with Steroid Injection for Sciatica from Herniated Disk: A Randomized Trial.

机构信息

From the Department of Radiological, Oncological, and Pathological Sciences, Policlinico Umberto I-Sapienza University of Rome, Viale del Policlinico 155, Rome 00161, Italy (A.N., G.A., A.D.M., R.S., P.G.N., S.P., C.C.); Spine Unit, Centro SaNa Servizi Sanitari Privati, Aprilia, Italy (A.N., E.P., R.S., R.T., J.L.); Department of Diagnostic and Interventional Radiology, IRCCS Istituto Ortopedico Rizzoli, Bologna, Italy (G.F., U.A., P.S., A.B.); Department of Radiology, Stanford University, Stanford, Calif (P.G.); and Department of Orthopaedic Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass (A.J.S.).

出版信息

Radiology. 2023 May;307(4):e221478. doi: 10.1148/radiol.221478. Epub 2023 Mar 28.

Abstract

Background Evidence regarding effective nonsurgical management of sciatica remains limited. Purpose To determine a difference in effectiveness between combined pulsed radiofrequency (PRF) and transforaminal epidural steroid injection (TFESI) treatment versus TFESI alone for sciatic pain due to lumbar disk herniation. Materials and Methods This prospective multicenter double-blind randomized clinical trial was conducted between February 2017 and September 2019 in participants with sciatica due to lumbar disk herniation lasting 12 weeks or longer that was not responsive to conservative treatment. Study participants were randomly assigned to undergo one CT-guided treatment with combined PRF and TFESI ( = 174) or TFESI alone ( = 177). The primary outcome was leg pain severity, as assessed with the numeric rating scale (NRS) (range, 0-10) at weeks 1 and 52 after treatment. Secondary outcomes included Roland-Morris Disability Questionnaire (RMDQ) score (range, 0-24) and Oswestry Disability Index (ODI) score (range, 0-100). Outcomes were analyzed according to the intention-to-treat principle via linear regression. Results Mean age of the 351 participants (223 men) was 55 years ± 16 (SD). At baseline, NRS was 8.1 ± 1.1 in the PRF and TFESI group and 7.9 ± 1.1 in the TFESI group. NRS was 3.2 ± 0.2 in the PRF and TFESI group and 5.4 ± 0.2 in the TFESI group (average treatment effect, 2.3; 95% CI: 1.9, 2.8; < .001) at week 1 and 1.0 ± 0.2 and 3.9 ± 0.2 (average treatment effect, 3.0; 95% CI: 2.4, 3.5; < .001), respectively, at week 52. At week 52, the average treatment effect was 11.0 (95% CI: 6.4, 15.6; < .001) for ODI and 2.9 (95% CI: 1.6, 4.3; < .001) for RMDQ, favoring the combined PRF and TFSEI group. Adverse events were reported in 6% (10 of 167) of participants in the PRF and TFESI group and in 3% (six of 176) of participants in the TFESI group (eight participants did not complete follow-up questionnaires). No severe adverse events occurred. Conclusion In the treatment of sciatica caused by lumbar disk herniation, pulsed radiofrequency combined with transforaminal epidural steroid injection is more effective for pain relief and disability improvement than steroid injection alone. © RSNA, 2023 See also the editorial by Jennings in this issue.

摘要

背景 关于坐骨神经痛的非手术治疗效果的证据仍然有限。

目的 旨在确定脉冲射频(PRF)联合经椎间孔硬膜外类固醇注射(TFESI)与单独 TFESI 治疗腰椎间盘突出症所致坐骨神经痛的效果差异。

材料与方法 本前瞻性多中心双盲随机临床试验于 2017 年 2 月至 2019 年 9 月进行,纳入因腰椎间盘突出症导致的坐骨神经痛持续 12 周或以上且对保守治疗无反应的患者。研究参与者被随机分配接受一次 CT 引导的联合 PRF 和 TFESI 治疗(n = 174)或单独 TFESI 治疗(n = 177)。主要结局是治疗后 1 周和 52 周时腿部疼痛严重程度,采用数字评分量表(NRS)(范围:0-10)评估。次要结局包括 Roland-Morris 残疾问卷(RMDQ)评分(范围:0-24)和 Oswestry 残疾指数(ODI)评分(范围:0-100)。根据意向治疗原则,通过线性回归分析评估结果。

结果 351 名参与者(223 名男性)的平均年龄为 55 岁 ± 16(SD)。基线时,PRF 和 TFESI 组的 NRS 为 8.1 ± 1.1,TFESI 组为 7.9 ± 1.1。PRF 和 TFESI 组治疗后第 1 周 NRS 为 3.2 ± 0.2,TFESI 组为 5.4 ± 0.2(平均治疗效果,2.3;95%CI:1.9,2.8;<.001),第 52 周时 NRS 分别为 1.0 ± 0.2 和 3.9 ± 0.2(平均治疗效果,3.0;95%CI:2.4,3.5;<.001)。第 52 周时,ODI 的平均治疗效果为 11.0(95%CI:6.4,15.6;<.001),RMDQ 为 2.9(95%CI:1.6,4.3;<.001),均有利于联合 PRF 和 TFSEI 组。PRF 和 TFESI 组有 6%(10/167)的参与者和 TFESI 组有 3%(6/176)的参与者报告了不良事件(8 名参与者未完成随访问卷)。没有发生严重不良事件。

结论 在腰椎间盘突出症所致坐骨神经痛的治疗中,脉冲射频联合经椎间孔硬膜外类固醇注射在缓解疼痛和改善残疾方面比单独使用类固醇注射更有效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d13b/10323291/ac0cc4baee2d/radiol.221478.VA.jpg

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