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用于慢性下腰痛的治疗性超声

Therapeutic ultrasound for chronic low back pain.

作者信息

Ebadi Safoora, Henschke Nicholas, Forogh Bijan, Nakhostin Ansari Noureddin, van Tulder Maurits W, Babaei-Ghazani Arash, Fallah Ehsan

机构信息

Department of Physical Medicine and Rehabilitation, School of Medicine, Iran University of Medical Sciences, Tehran, Iran.

Neuromusculoskeletal Research Center, Iran University of Medical Sciences, Tehran, Iran.

出版信息

Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD009169. doi: 10.1002/14651858.CD009169.pub3.

Abstract

BACKGROUND

This is an update of a Cochrane Review published in 2014. Chronic non-specific low back pain (LBP) has become one of the main causes of disability in the adult population around the world. Although therapeutic ultrasound is not recommended in recent clinical guidelines, it is frequently used by physiotherapists in the treatment of chronic LBP.

OBJECTIVES

The objective of this review was to determine the effectiveness of therapeutic ultrasound in the management of chronic non-specific LBP. A secondary objective was to determine the most effective dosage and intensity of therapeutic ultrasound for chronic LBP.

SEARCH METHODS

We performed electronic searches in CENTRAL, MEDLINE, Embase, CINAHL, PEDro, Index to Chiropractic Literature, and two trials registers to 7 January 2020. We checked the reference lists of eligible studies and relevant systematic reviews and performed forward citation searching.

SELECTION CRITERIA

We included randomised controlled trials (RCTs) on therapeutic ultrasound for chronic non-specific LBP. We compared ultrasound (either alone or in combination with another treatment) with placebo or other interventions for chronic LBP.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed the risk of bias of each trial and extracted the data. We performed a meta-analysis when sufficient clinical and statistical homogeneity existed. We determined the certainty of the evidence for each comparison using the GRADE approach.

MAIN RESULTS

We included 10 RCTs involving a total of 1025 participants with chronic LBP. The included studies were carried out in secondary care settings in Turkey, Iran, Saudi Arabia, Croatia, the UK, and the USA, and most applied therapeutic ultrasound in addition to another treatment, for six to 18 treatment sessions. The risk of bias was unclear in most studies. Eight studies (80%) had unclear or high risk of selection bias; no studies blinded care providers to the intervention; and only five studies (50%) blinded participants. There was a risk of selective reporting in eight studies (80%), and no studies adequately assessed compliance with the intervention. There was very low-certainty evidence (downgraded for imprecision, inconsistency, and limitations in design) of little to no difference between therapeutic ultrasound and placebo for short-term pain improvement (mean difference (MD) -7.12, 95% confidence interval (CI) -17.99 to 3.75; n = 121, 3 RCTs; 0-to-100-point visual analogue scale (VAS)). There was also moderate-certainty evidence (downgraded for imprecision) of little to no difference in the number of participants achieving a 30% reduction in pain in the short term (risk ratio 1.08, 95% CI 0.81 to 1.44; n = 225, 1 RCT). There was low-certainty evidence (downgraded for imprecision and limitations in design) that therapeutic ultrasound has a small effect on back-specific function compared with placebo in the short term (standardised mean difference -0.29, 95% CI -0.51 to -0.07 (MD -1.07, 95% CI -1.89 to -0.26; Roland Morris Disability Questionnaire); n = 325; 4 RCTs), but this effect does not appear to be clinically important. There was moderate-certainty evidence (downgraded for imprecision) of little to no difference between therapeutic ultrasound and placebo on well-being (MD -2.71, 95% CI -9.85 to 4.44; n = 267, 2 RCTs; general health subscale of the 36-item Short Form Health Survey (SF-36)). Two studies (n = 486) reported on overall improvement and satisfaction between groups, and both reported little to no difference between groups (low-certainty evidence, downgraded for serious imprecision). One study (n = 225) reported on adverse events and did not identify any adverse events related to the intervention (low-certainty evidence, downgraded for serious imprecision). No study reported on disability for this comparison. We do not know whether therapeutic ultrasound in addition to exercise results in better outcomes than exercise alone because the certainty of the evidence for all outcomes was very low (downgraded for imprecision and serious limitations in design). The estimate effect for pain was in favour of the ultrasound plus exercise group (MD -21.1, 95% CI -27.6 to -14.5; n = 70, 2 RCTs; 0-to-100-point VAS) at short term. Regarding back-specific function (MD - 0.41, 95% CI -3.14 to 2.32; n = 79, 2 RCTs; Oswestry Disability Questionnaire) and well-being (MD -2.50, 95% CI -9.53 to 4.53; n = 79, 2 RCTs; general health subscale of the SF-36), there was little to no difference between groups at short term. No studies reported on the number of participants achieving a 30% reduction in pain, patient satisfaction, disability, or adverse events for this comparison.

AUTHORS' CONCLUSIONS: The evidence from this systematic review is uncertain regarding the effect of therapeutic ultrasound on pain in individuals with chronic non-specific LBP. Whilst there is some evidence that therapeutic ultrasound may have a small effect on improving low back function in the short term compared to placebo, the certainty of evidence is very low. The true effect is likely to be substantially different. There are few high-quality randomised trials, and the available trials were very small. The current evidence does not support the use of therapeutic ultrasound in the management of chronic LBP.

摘要

背景

这是对2014年发表的一篇Cochrane系统评价的更新。慢性非特异性腰痛(LBP)已成为全球成年人群致残的主要原因之一。尽管近期临床指南不推荐使用治疗性超声,但物理治疗师在治疗慢性腰痛时经常使用。

目的

本系统评价的目的是确定治疗性超声在慢性非特异性腰痛管理中的有效性。次要目的是确定治疗性超声治疗慢性腰痛的最有效剂量和强度。

检索方法

我们在CENTRAL、MEDLINE、Embase、CINAHL、PEDro、脊椎按摩文献索引以及两个试验注册库中进行了电子检索,检索截至2020年1月7日。我们检查了纳入研究和相关系统评价的参考文献列表,并进行了正向引文检索。

入选标准

我们纳入了关于治疗性超声治疗慢性非特异性腰痛的随机对照试验(RCT)。我们将超声(单独使用或与其他治疗联合使用)与慢性腰痛的安慰剂或其他干预措施进行了比较。

数据收集与分析

两位综述作者独立评估了每项试验的偏倚风险并提取了数据。当存在足够的临床和统计学同质性时,我们进行了荟萃分析。我们使用GRADE方法确定了每次比较的证据确定性。

主要结果

我们纳入了10项RCT,共1025名慢性腰痛患者。纳入的研究在土耳其、伊朗、沙特阿拉伯、克罗地亚、英国和美国的二级医疗机构中进行,大多数研究除了采用其他治疗外还应用了治疗性超声,治疗疗程为6至18次。大多数研究的偏倚风险不明确。八项研究(80%)存在不明确或高选择偏倚风险;没有研究对护理提供者实施干预进行盲法;只有五项研究(50%)对参与者实施了盲法。八项研究(80%)存在选择性报告风险,没有研究充分评估干预措施的依从性。对于短期疼痛改善,治疗性超声与安慰剂之间几乎没有差异,证据确定性极低(因不精确、不一致和设计局限性而降级)(平均差(MD)-7.12,95%置信区间(CI)-17.99至3.75;n = 121,3项RCT;0至100分视觉模拟量表(VAS))。对于短期内疼痛减轻30%的参与者数量,也有中度确定性证据(因不精确而降级)表明治疗性超声与安慰剂之间几乎没有差异(风险比1.08,95%CI 0.81至1.44;n = 225,1项RCT)。有低确定性证据(因不精确和设计局限性而降级)表明,与安慰剂相比,治疗性超声在短期内对背部特定功能有小的影响(标准化平均差-0.29,95%CI -0.51至-0.07(MD -1.07,95%CI -1.89至-0.26;罗兰·莫里斯残疾问卷);n = 325;4项RCT),但这种影响似乎在临床上并不重要。对于幸福感,有中度确定性证据(因不精确而降级)表明治疗性超声与安慰剂之间几乎没有差异(MD -2.71,95%CI -9.85至4.44;n = 267,2项RCT;36项简短健康调查问卷(SF-36)的一般健康子量表)。两项研究(n = 486)报告了组间的总体改善和满意度,均报告组间几乎没有差异(低确定性证据,因严重不精确而降级)。一项研究(n = 225)报告了不良事件,未发现与干预相关的任何不良事件(低确定性证据,因严重不精确而降级)。没有研究报告此比较中的残疾情况。我们不知道超声联合运动是否比单独运动能带来更好的结果,因为所有结局的证据确定性都非常低(因不精确和严重设计局限性而降级)。短期内疼痛的估计效应有利于超声加运动组(MD -21.1,95%CI -27.6至-14.5;n = 70,2项RCT;0至100分VAS)。关于背部特定功能(MD -0.41,95%CI -3.14至2.32;n = 79,2项RCT;Oswestry残疾问卷)和幸福感(MD -2.50,95%CI -9.53至4.53;n = 79,2项RCT;SF-36的一般健康子量表),短期内组间几乎没有差异。没有研究报告此比较中疼痛减轻30%的参与者数量、患者满意度、残疾情况或不良事件。

作者结论

本系统评价的证据对于治疗性超声对慢性非特异性腰痛患者疼痛的影响尚不确定。虽然有一些证据表明,与安慰剂相比,治疗性超声在短期内可能对改善腰椎功能有小的影响,但证据确定性非常低。真实效应可能有很大差异。高质量随机试验很少见,现有试验规模非常小。目前的证据不支持在慢性腰痛管理中使用治疗性超声。

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