Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada.
Michael G. DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.
BMJ Open. 2021 Jul 9;11(7):e046025. doi: 10.1136/bmjopen-2020-046025.
Chronic, non-cancer, axial or radicular spinal pain is a common condition associated with considerable socioeconomic burden. Clinicians frequently offer patients various interventional procedures for the treatment of chronic spine pain; however, the comparative effectiveness and safety of available procedures remains uncertain.
We will conduct a systematic review of randomised controlled trials that explores the effectiveness and harms of interventional procedures for the management of axial or radicular, chronic, non-cancer, spine pain. We will identify eligible studies through a systematic search of Medline, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials and Web of Science from inception without language restrictions. Eligible trials will: (1) enrol primarily adult patients (≥18 years old) with axial or radicular, chronic, non-cancer, spine pain, (2) randomise patients to different, currently available, interventional procedures or to an interventional procedure and a placebo/sham procedure or usual care, and (3) measure outcomes at least 1 month after randomisation.Pairs of reviewers will independently screen articles identified through searches and extract information and assess risk of bias of eligible trials. We will use a modified Cochrane instrument to evaluate risk of bias. We will use frequentist random-effects network meta-analyses to assess the relative effects of interventional procedures, and five a priori hypotheses to explore between studies subgroup effects. We will use the Grading of Recommendations Assessment, Development and Evaluation approach to assess the certainty in evidence for each outcome, including direct, indirect and network estimates.
No research ethics approval is required for this systematic review, as no confidential patient data will be used. We will disseminate our findings through publication in a peer-reviewed journal and conference presentations, and our review will support development of a Rapid Recommendations providing contextualised clinical guidance based on this body of evidence.
CRD42020170667.
慢性、非癌症、轴向或神经根性脊柱疼痛是一种常见的病症，与相当大的社会经济负担有关。临床医生经常为慢性脊柱疼痛患者提供各种介入性手术治疗；然而，现有手术的疗效和安全性仍不确定。
我们将对随机对照试验进行系统评价，探讨介入性手术治疗轴向或神经根性、慢性、非癌症、脊柱疼痛的有效性和危害。我们将通过系统检索 Medline、EMBASE、CINAHL、Cochrane 对照试验中心注册库和 Web of Science，从成立之初开始，在不限制语言的情况下确定合格的研究。合格的试验将：（1）纳入主要为患有轴向或神经根性、慢性、非癌症、脊柱疼痛的成年患者（≥18 岁）；（2）将患者随机分配到不同的、目前可用的介入性手术或介入性手术与安慰剂/假手术或常规护理；（3）至少在随机分组后 1 个月测量结局。 pairs of reviewers 将独立筛选通过搜索确定的文章，并提取信息和评估合格试验的偏倚风险。我们将使用修改后的 Cochrane 工具评估偏倚风险。我们将使用频率随机效应网络荟萃分析来评估介入性手术的相对效果，并使用五个事先假设来探索研究之间的亚组效应。我们将使用推荐评估、制定和评估方法来评估每个结局的证据确定性，包括直接、间接和网络估计。
由于本系统评价不使用任何机密患者数据，因此不需要研究伦理批准。我们将通过在同行评议期刊上发表和会议演示来传播我们的发现，我们的审查将支持快速推荐的制定，该推荐将基于这一证据体提供基于背景的临床指导。
PROSPERO 注册号：CRD42020170667。
