Maas Esther T, Ostelo Raymond W J G, Niemisto Leena, Jousimaa Jukkapekka, Hurri Heikki, Malmivaara Antti, van Tulder Maurits W
Department of Health Sciences, Faculty of Earth and Life Sciences, VU University Amsterdam, Amsterdam, Netherlands.
Cochrane Database Syst Rev. 2015 Oct 23;2015(10):CD008572. doi: 10.1002/14651858.CD008572.pub2.
Radiofrequency (RF) denervation, an invasive treatment for chronic low back pain (CLBP), is used most often for pain suspected to arise from facet joints, sacroiliac (SI) joints or discs. Many (uncontrolled) studies have shown substantial variation in its use between countries and continued uncertainty regarding its effectiveness.
The objective of this review is to assess the effectiveness of RF denervation procedures for the treatment of patients with CLBP. The current review is an update of the review conducted in 2003.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, three other databases, two clinical trials registries and the reference lists of included studies from inception to May 2014 for randomised controlled trials (RCTs) fulfilling the inclusion criteria. We updated this search in June 2015, but we have not yet incorporated these results.
We included RCTs of RF denervation for patients with CLBP who had a positive response to a diagnostic block or discography. We applied no language or date restrictions.
Pairs of review authors independently selected RCTs, extracted data and assessed risk of bias (RoB) and clinical relevance using standardised forms. We performed meta-analyses with clinically homogeneous studies and assessed the quality of evidence for each outcome using the Grades of Recommendation, Assessment, Development and Evaluation (GRADE) approach.
In total, we included 23 RCTs (N = 1309), 13 of which (56%) had low RoB. We included both men and women with a mean age of 50.6 years. We assessed the overall quality of the evidence as very low to moderate. Twelve studies examined suspected facet joint pain, five studies disc pain, two studies SI joint pain, two studies radicular CLBP, one study suspected radiating low back pain and one study CLBP with or without suspected radiation. Overall, moderate evidence suggests that facet joint RF denervation has a greater effect on pain compared with placebo over the short term (mean difference (MD) -1.47, 95% confidence interval (CI) -2.28 to -0.67). Low-quality evidence indicates that facet joint RF denervation is more effective than placebo for function over the short term (MD -5.53, 95% CI -8.66 to -2.40) and over the long term (MD -3.70, 95% CI -6.94 to -0.47). Evidence of very low to low quality shows that facet joint RF denervation is more effective for pain than steroid injections over the short (MD -2.23, 95% CI -2.38 to -2.08), intermediate (MD -2.13, 95% CI -3.45 to -0.81), and long term (MD -2.65, 95% CI -3.43 to -1.88). RF denervation used for disc pain produces conflicting results, with no effects for RF denervation compared with placebo over the short and intermediate term, and small effects for RF denervation over the long term for pain relief (MD -1.63, 95% CI -2.58 to -0.68) and improved function (MD -6.75, 95% CI -13.42 to -0.09). Lack of evidence of short-term effectiveness undermines the clinical plausibility of intermediate-term or long-term effectiveness. When RF denervation is used for SI joint pain, low-quality evidence reveals no differences from placebo in effects on pain (MD -2.12, 95% CI -5.45 to 1.21) and function (MD -14.06, 95% CI -30.42 to 2.30) over the short term, and one study shows a small effect on both pain and function over the intermediate term. RF denervation is an invasive procedure that can cause a variety of complications. The quality and size of original studies were inadequate to permit assessment of how often complications occur.
AUTHORS' CONCLUSIONS: The review authors found no high-quality evidence suggesting that RF denervation provides pain relief for patients with CLBP. Similarly, we identified no convincing evidence to show that this treatment improves function. Overall, the current evidence for RF denervation for CLBP is very low to moderate in quality; high-quality evidence is lacking. High-quality RCTs with larger patient samples are needed, as are data on long-term effects.
射频去神经术是一种用于治疗慢性下腰痛(CLBP)的侵入性治疗方法,最常用于怀疑由小关节、骶髂关节或椎间盘引起的疼痛。许多(非对照)研究表明,各国在该方法的使用上存在很大差异,其有效性也一直存在不确定性。
本综述的目的是评估射频去神经术治疗CLBP患者的有效性。本次综述是对2003年所做综述的更新。
我们检索了Cochrane对照试验中心注册库(CENTRAL)、MEDLINE、EMBASE以及其他三个数据库、两个临床试验注册库,并检索了纳入研究从创刊至2014年5月的参考文献列表,以查找符合纳入标准的随机对照试验(RCT)。我们于2015年6月更新了该检索,但尚未纳入这些结果。
我们纳入了对诊断性阻滞或椎间盘造影有阳性反应的CLBP患者的射频去神经术RCT。我们未设语言或日期限制。
由两位综述作者独立选择RCT,提取数据,并使用标准化表格评估偏倚风险(RoB)和临床相关性。我们对临床同质的研究进行了荟萃分析,并使用推荐分级、评估、制定与评价(GRADE)方法评估每个结局的证据质量。
我们总共纳入了23项RCT(N = 1309),其中13项(56%)的RoB较低。纳入的患者包括男性和女性,平均年龄为50.6岁。我们评估证据的总体质量为极低到中等。12项研究探讨了疑似小关节疼痛,5项研究椎间盘疼痛,2项研究骶髂关节疼痛,2项研究根性CLBP,1项研究疑似放射性下腰痛,1项研究有或无疑似放射痛的CLBP。总体而言,中等质量的证据表明,与安慰剂相比,小关节射频去神经术在短期内对疼痛的影响更大(平均差(MD)-1.47,95%置信区间(CI)-2.28至-0.67)。低质量证据表明,小关节射频去神经术在短期内(MD -5.53,95% CI -8.66至-2.40)和长期内(MD -3.70,95% CI -6.94至-0.47)对功能的改善比安慰剂更有效。极低到低质量的证据表明,小关节射频去神经术在短期(MD -2.23,95% CI -2.38至-2.08)、中期(MD -2.13,95% CI -3.45至-0.81)和长期(MD -2.65,95% CI -3.43至-1.88)对疼痛的缓解比类固醇注射更有效。用于椎间盘疼痛的射频去神经术产生了相互矛盾的结果,与安慰剂相比,在短期和中期对疼痛无影响,在长期对疼痛缓解(MD -1.63,95% CI -2.58至-0.68)和功能改善(MD -6.75,95% CI -13.42至-0.09)有小的影响。缺乏短期有效性的证据削弱了中期或长期有效性的临床合理性。当射频去神经术用于骶髂关节疼痛时,低质量证据显示在短期内对疼痛(MD -2.12,95% CI -5.45至1.21)和功能(MD -14.06,95% CI -30.42至2.30)的影响与安慰剂无差异,一项研究显示在中期对疼痛和功能有小的影响。射频去神经术是一种侵入性手术,可以导致各种并发症。原始研究的质量和规模不足以评估并发症发生的频率。
综述作者未发现高质量证据表明射频去神经术能为CLBP患者缓解疼痛。同样,我们也未找到令人信服的证据表明这种治疗能改善功能。总体而言,目前关于CLBP的射频去神经术的证据质量极低到中等;缺乏高质量证据。需要有更大患者样本量的高质量RCT,以及关于长期效果的数据。