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评估经皮射频治疗骶髂关节疼痛效果的随机假对照双盲多中心临床试验:三个月结果

Randomized Sham-controlled Double-Blind Multicenter Clinical Trial to Ascertain the Effect of Percutaneous Radiofrequency Treatment for Sacroiliac Joint Pain: Three-month Results.

作者信息

van Tilburg Cornelis W J, Schuurmans Fleur A, Stronks Dirk L, Groeneweg Johannes G, Huygen Frank J P M

机构信息

*Department of Anesthesiology, Multidisciplinary Pain Center, Bravis Hospital, Boerhaaveplein, Bergen op Zoom †Center for Pain Medicine, Erasmus University Medical Centre, Rotterdam, The Netherlands.

出版信息

Clin J Pain. 2016 Nov;32(11):921-926. doi: 10.1097/AJP.0000000000000351.


DOI:10.1097/AJP.0000000000000351
PMID:26889616
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5640001/
Abstract

OBJECTIVES: To investigate the effect of a percutaneous radiofrequency (RF) heat lesion compared with a sham procedure, applied to the lateral branches of L5, S1, S2, S3, and S4 nerve roots. MATERIALS AND METHODS: Sixty patients aged 18 years and above with a medical history and physical examination suggestive for sacroiliac joint pain and a reduction of 2 or more on a numerical rating scale (NRS, 0 to 10) after a sacroiliac joint test block were included in this study. Treatment group: percutaneous RF heat lesion at the lateral branches of S1, S2, S3, and S4 nerve roots and the posterior ramus dorsalis of L5; sham group: same procedure as the treatment group except for the RF heat lesion. PRIMARY OUTCOME MEASURE: pain reduction (NRS). Secondary outcome measure: Global Perceived Effect. RESULTS: No statistically significant differences in pain level over time between the groups (Group×Period) (F1,58=0.353; P=0.56) nor within the treatment Group (F1,58=0.212; P=0.65) were found. The Period factor, however, yielded a significant difference (F1,58=61.67; P<0.001), that is, when pooled together the mean pain level of the patients was significantly reduced at T1 compared with T0. In the crossover group, 42.1% experienced a reduction in NRS of 2 or more at 1 month (P=0.65). No statistically significant difference in satisfaction over time between the groups was found (F1,50=2.1; P=0.15). The independent factors Group (F1,50=2.02; P=0.16) and Period (F1,50=0.95; P=0.33) also showed no statistically significant difference. The same applies to recovery: no statistically significant Group×Period effect (F1,51=0.09; P=0.77) was found, neither an effect of Group (F1,51=0.004; P=0.95) nor of Period (F1,51=0.27; P=0.60). DISCUSSION: The hypothesis of no difference in pain reduction or in Global Perceived Effect between the treatment and sham group cannot be rejected. LEVEL OF EVIDENCE: Level 1A.

摘要

目的:研究经皮射频(RF)热凝术与假手术相比,应用于L5、S1、S2、S3和S4神经根外侧支的效果。 材料与方法:本研究纳入60例年龄18岁及以上、有骶髂关节疼痛病史且经骶髂关节试验性阻滞后腰腿痛数字评分量表(NRS,0至10)降低2分或更多的患者。治疗组:对S1、S2、S3和S4神经根外侧支以及L5后支进行经皮RF热凝术;假手术组:除不进行RF热凝术外,操作步骤与治疗组相同。 主要观察指标:疼痛减轻程度(NRS)。次要观察指标:整体感觉效果。 结果:两组间随时间的疼痛水平无统计学显著差异(组×时间)(F1,58 = 0.353;P = 0.56),治疗组内也无差异(F1,58 = 0.212;P = 0.65)。然而,时间因素有显著差异(F1,58 = 61.67;P < 0.001),即汇总后患者的平均疼痛水平在T1时与T0相比显著降低。在交叉组中,42.1%的患者在1个月时NRS降低2分或更多(P = 0.65)。两组间随时间的满意度无统计学显著差异(F1,50 = 2.1;P = 0.15)。独立因素组(F1,50 = 2.02;P = 0.16)和时间(F1,50 = 0.95;P = 0.33)也无统计学显著差异。恢复情况同样如此:未发现组×时间的显著效应(F1,51 = 0.09;P = 0.77),组效应(F1,51 = 0.004;P = 0.95)和时间效应(F1,51 = 0.27;P = 0.60)也未发现。 讨论:不能拒绝治疗组与假手术组在疼痛减轻或整体感觉效果上无差异的假设。 证据级别:1A 级。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c72/5640001/08af6694ad60/ajp-32-921-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c72/5640001/f0d4bdb3f7d3/ajp-32-921-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c72/5640001/763098f7be8a/ajp-32-921-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c72/5640001/08af6694ad60/ajp-32-921-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c72/5640001/f0d4bdb3f7d3/ajp-32-921-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c72/5640001/763098f7be8a/ajp-32-921-g005.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1c72/5640001/08af6694ad60/ajp-32-921-g007.jpg

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本文引用的文献

[1]
Cooled radiofrequency denervation for treatment of sacroiliac joint pain: two-year results from 20 cases.

J Pain Res. 2013-7-4

[2]
Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: a large case series.

Pain Med. 2012-12-28

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Expert Rev Neurother. 2013-1

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Pain Pract. 2011

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J Clin Epidemiol. 2010-1-8

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Anesthesiology. 2008-8

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