McGregor Alison H, Probyn Katrin, Cro Suzie, Doré Caroline J, Burton A Kim, Balagué Federico, Pincus Tamar, Fairbank Jeremy
Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Charing Cross Hospital, London, UK, W6 8RF.
Cochrane Database Syst Rev. 2013 Dec 9;2013(12):CD009644. doi: 10.1002/14651858.CD009644.pub2.
Lumbar spinal stenosis is a common cause of back pain that can also give rise to pain in the buttock, thigh or leg, particularly when walking. Several possible treatments are available, of which surgery appears to be best at restoring function and reducing pain. Surgical outcome is not ideal, and a sizeable proportion of patients do not regain good function. No accepted evidence-based approach to postoperative care is known-a fact thathas prompted this review.
To determine whether active rehabilitation programmes following primary surgery for lumbar spinal stenosis have an impact on functional outcomes and whether such programmes are superior to 'usual postoperative care'.
We searched the following databases from their first issues to March 2013: CENTRAL (The Cochrane Library, most recent issue), the Cochrane Back Review Group Trials Register, MEDLINE, EMBASE, CINAHL and PEDro.
We considered randomised controlled trials (RCTs) that compared the effectiveness of active rehabilitation versus usual care in adults (> 18 years of age) with confirmed lumbar spinal stenosis who had undergone spinal decompressive surgery (with or without fusion) for the first time.
Two review authors independently extracted data from the included trials by using a predeveloped form. We contacted authors of original trials to request additional unpublished data as required. We recorded baseline characteristics of participants, interventions, comparisons, follow-up and outcome measures to enable assessment of clinical homogeneity. Clinical relevance was independently assessed by using the five questions recommended by the Cochrane Back Review Group (CBRG), and risk of bias within studies was determined by using CBRG criteria.We pooled individual study results in a meta-analysis when appropriate. For continuous outcomes, we calculated the mean difference (MD) when the same measurement scales were used in all studies and the standardised mean difference (SMD) when different measurement scales were used. Whenreported means and standard deviations of the outcomes showed that outcome data were skewed, we log-transformed data for all studies in the comparison and performed a meta-analysis on the log-scale. Results of analyses performed on the log-scale were converted back to the original scale. We used a fixed-effect inverse variance model to measure treatment effect when no substantial evidence of statistical heterogeneity was found. When we detected substantial statistical heterogeneity, we used a random-effects inverse variance model.The primary outcome measure was functional status as measured by a back-specific functional scale. Secondary outcomes included measures of leg pain, low back pain and global improvement/general health. We considered statistical significance and clinical relevance of outcomes. We used the GRADE approach to assess the overall quality of evidence for each outcome on the basis of five criteria, for which evidence was ranked from high to very low quality, depending on the number of criteria met.
Our searches yielded 1,726 results, and a total of three studies (N = 373 participants) were included in the review and meta-analysis. All studies were deemed to have low risk of bias; no study had unacceptably high dropout rates. Also, no unacceptably unbalanced dropout rates, unacceptably low adherence rates or non-adherence to the protocol or clearly significant unbalanced baseline differences were noted for the primary outcome. Outcomes in the short term (within six months postoperative)Evidence of moderate quality from three RCTs (N = 340) shows that active rehabilitation is more effective than usual care for functional status (log SMD -0.22, 95% confidence interval (CI) -0.44 to 0.00, corresponding to an average percentage improvement (reduction in standardised functional score) of 20%, 95% CI 0% to 36%) and for reported low back pain (log MD -0.18, 95% CI-0.35 to -0.02, corresponding to an average percentage improvement (reduction in VAS score) of 16%, 95% CI 2% to 30%). In contrast, evidence of low quality suggests that rehabilitation is no more effective than usual care for leg pain (log MD -0.17, 95% CI -0.52 to 0.19, corresponding to an average percentage improvement (reduction in VAS score) of 16%, 95% CI 21% worsening to 41% improvement). Low-quality evidence from two RCTs (N = 238) indicates that rehabilitation has no additional benefit on general health status as compared to usual care (MD 1.30, 95% CI -4.45 to 7.06). Outcomes in the long term (at 12 months postoperative)Evidence of moderate quality from three RCTs (N = 373) shows that rehabilitation is more effective than usual care for functional status (log SMD -0.26, 95% CI -0.46 to -0.05, corresponding to an average percentage improvement (reduction in standardised functional score) of 23%, 95% CI 5% to 37%), for reported low back pain (log MD -0.20, 95% CI -0.36 to -0.05, corresponding to an average percentage improvement (reduction in VAS score) of 18%, 95% CI 5% to 30%]. Evidence of moderate quality (N = 373) and for leg pain (log MD -0.24, 95% CI -0.47 to -0.01, corresponding to an average percentage improvement (reduction in VAS score) of 21%, 95% CI 1% to 37%). In contrast, evidence of low quality from two studies (N = 273) suggests that rehabilitation is no more effective than usual care with respect to improvement in general health (MD -0.48, 95% CI -6.41 to 5.4).None of the included papers reported any relevant adverse events.
AUTHORS' CONCLUSIONS: Evidence suggests that active rehabilitation is more effective than usual care in improving both short- and long-term (back-related) functional status. Similar findings were noted for secondary outcomes, including short-term improvement in low back pain and long-term improvement in both low back pain and leg pain, although limited impact was observed in relation to improvements in general health status. The clinical relevance of these effects is medium to small. Our evaluation is limited by the small number of relevant studies identified, and further research is required.
腰椎管狭窄症是引起背痛的常见原因,也可导致臀部、大腿或腿部疼痛,尤其是在行走时。目前有几种可能的治疗方法,其中手术似乎在恢复功能和减轻疼痛方面效果最佳。手术效果并不理想,相当一部分患者无法恢复良好的功能。目前尚无公认的基于证据的术后护理方法,这一事实促使了本次综述。
确定腰椎管狭窄症初次手术后的积极康复计划是否对功能结局有影响,以及此类计划是否优于“常规术后护理”。
我们检索了以下数据库从创刊号至2013年3月的数据:CENTRAL(考克兰图书馆,最新期)、考克兰背部综述小组试验注册库、MEDLINE、EMBASE、CINAHL和PEDro。
我们纳入了比较积极康复与常规护理对确诊为腰椎管狭窄症且首次接受脊柱减压手术(有或无融合)的成年人(>18岁)有效性的随机对照试验(RCT)。
两位综述作者使用预先制定的表格独立从纳入的试验中提取数据。我们根据需要联系原始试验的作者以获取额外的未发表数据。我们记录了参与者的基线特征、干预措施、对照、随访和结局指标,以便评估临床同质性。临床相关性由考克兰背部综述小组(CBRG)推荐的五个问题独立评估,研究中的偏倚风险由CBRG标准确定。我们在适当的时候将个体研究结果汇总进行荟萃分析。对于连续性结局,当所有研究使用相同的测量量表时,我们计算平均差(MD);当使用不同的测量量表时,我们计算标准化平均差(SMD)。当结局的报告均值和标准差显示结局数据存在偏态时,我们对比较中的所有研究数据进行对数转换,并在对数尺度上进行荟萃分析。在对数尺度上进行的分析结果再转换回原始尺度。当未发现明显的统计学异质性证据时,我们使用固定效应逆方差模型来测量治疗效果。当我们检测到明显的统计学异质性时,我们使用随机效应逆方差模型。主要结局指标是通过背部特异性功能量表测量的功能状态。次要结局包括腿痛、腰痛和整体改善/总体健康的测量指标。我们考虑了结局的统计学意义和临床相关性。我们使用GRADE方法根据五个标准评估每个结局的证据总体质量,根据满足标准的数量,证据质量从高到极低进行排序。
我们的检索产生了1726条结果,共有三项研究(N = 373名参与者)纳入了综述和荟萃分析。所有研究的偏倚风险均被认为较低;没有研究的失访率高到不可接受。此外,对于主要结局,未发现失访率不可接受地不均衡、依从率低到不可接受或不遵守方案,也未发现明显的基线差异不均衡。短期(术后六个月内)结局三项RCT(N = 340)的中等质量证据表明,对于功能状态(对数SMD -0.22,95%置信区间(CI)-0.44至0.00,相当于平均改善百分比(标准化功能评分降低)20%,95% CI 0%至36%)和报告的腰痛(对数MD -0.18,95% CI -0.35至-0.02,相当于平均改善百分比(VAS评分降低)16%,95% CI 2%至30%),积极康复比常规护理更有效。相比之下,低质量证据表明,对于腿痛,康复并不比常规护理更有效(对数MD -0.17,95% CI -0.52至0.19,相当于平均改善百分比(VAS评分降低)16%,95% CI 恶化21%至改善41%)。两项RCT(N = 238)的低质量证据表明,与常规护理相比,康复对总体健康状况没有额外益处(MD 1.30,95% CI -4.45至7.06)。长期(术后12个月)结局三项RCT(N = 373)的中等质量证据表明,对于功能状态(对数SMD -0.26,95% CI -0.46至-0.05,相当于平均改善百分比(标准化功能评分降低)23%,95% CI 5%至37%)、报告的腰痛(对数MD -0.20,95% CI -0.36至-0.05,相当于平均改善百分比(VAS评分降低)18%,95% CI 5%至30%),康复比常规护理更有效。中等质量证据(N = 373)表明,对于腿痛(对数MD -0.24,95% CI -0.47至-0.01,相当于平均改善百分比(VAS评分降低)21%,95% CI 1%至37%)也是如此。相比之下,两项研究(N = 273)的低质量证据表明,在总体健康改善方面,康复并不比常规护理更有效(MD -0.48,95% CI -6.41至5.4)。纳入的论文均未报告任何相关不良事件。
有证据表明,积极康复在改善短期和长期(与背部相关的)功能状态方面比常规护理更有效。在次要结局方面也有类似发现,包括短期腰痛改善以及长期腰痛和腿痛改善,尽管在总体健康状况改善方面观察到的影响有限。这些效果的临床相关性为中到小。我们的评估受到所确定的相关研究数量较少的限制,需要进一步研究。