School of Biomedical Sciences and Pharmacy, Faculty of Health and Pharmacy, University of Newcastle, Callaghan, NSW, Australia.
School of Health Sciences, University of Newcastle, Callaghan, NSW, Australia.
Headache. 2020 Jan;60(1):15-27. doi: 10.1111/head.13719. Epub 2019 Dec 9.
The aim of this study was to determine the diagnostic criteria used in randomized controlled trials to define trial participants as having cervicogenic headache (CeH).
While animal and human studies suggest a biological basis for "cervicogenic" headaches the diagnostic criteria necessary to evidence CeH are debated.
A systematic review was undertaken guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. An electronic search of MEDLINE, Cochrane, CINHAL, Pedro, AMED, and EMBASE online databases of randomized controlled trials published between January 1983 and October 2018 found 39 randomized controlled trials which met the study inclusion criteria.
Two independent reviewers found most trials cited 1 (31/39; 79.5%) or more (3/39; 7.6%) references to define the criteria used to identify CeH in their study participants. In spite of updated publications concerning the characteristics and definition of CeH, many (27/39; 69.2%) used diagnostic criteria published between 5 and 24 years prior to the randomized controlled trial. The most commonly cited diagnostic criteria included unilateral headache (18/39; 46.2%), cervical movement or sustained posture that either provoked (18/39; 46.2%) or precipitated (17/39; 43.6%) the headache. Fifteen trials did not exclude participants with signs or symptoms of other forms of headache. Although anesthetic blockade of cervical tissue or nerves is considered necessary for a "definitive" diagnosis, only 7.6% (3/39) of trials used anesthetic blockade at recruitment.
This systematic review evidences the heterogeneity in the clinical characteristics used to diagnose CeH in participants recruited in randomized controlled trials. It raises a significant concern about the usefulness of currently available randomized controlled trials to determine the clinical merits of the treatment and management of people with CeHs. Our systematic review suggests that most randomized controlled trials published to date have investigated headaches with a clinical presentation involving the neck that maybe better defined as "possible," "probable," or "definitive" CeH depending on how well the diagnostic criteria used align with the most recent edition (3rd) of the International Classification of Headache Disorders.
本研究旨在确定用于随机对照试验中定义试验参与者患有颈源性头痛（CeH）的诊断标准。
虽然动物和人体研究表明存在“颈源性”头痛的生物学基础，但用于证明 CeH 的诊断标准仍存在争议。
本研究采用系统综述的方法，遵循《系统综述和荟萃分析的首选报告项目》的指导原则。对 1983 年 1 月至 2018 年 10 月期间发表的随机对照试验的 MEDLINE、Cochrane、CINHAL、Pedro、AMED 和 EMBASE 在线数据库进行了电子检索，共找到 39 项符合研究纳入标准的随机对照试验。
两位独立的审查员发现，大多数试验引用了 1 项（39 项中的 31 项；79.5%）或更多（39 项中的 3 项；7.6%）的参考文献来定义用于识别试验参与者 CeH 的标准。尽管有关 CeH 的特征和定义的更新出版物不断出现，但许多（39 项中的 27 项；69.2%）仍使用在随机对照试验之前 5 至 24 年发布的诊断标准。最常引用的诊断标准包括单侧头痛（39 项中的 18 项；46.2%）、颈椎运动或持续姿势，可引发（39 项中的 18 项；46.2%）或引发（39 项中的 17 项；43.6%）头痛。15 项试验未排除具有其他类型头痛体征或症状的参与者。尽管认为对颈部组织或神经进行麻醉阻滞是诊断 CeH 的必要条件，但只有 7.6%（39 项中的 3 项）的试验在招募时使用了麻醉阻滞。
本系统综述证明了在随机对照试验中招募的参与者中用于诊断 CeH 的临床特征存在异质性。这引起了人们对当前可用的随机对照试验在确定 CeH 患者治疗和管理的临床价值方面的有效性的严重关注。我们的系统综述表明，迄今为止发表的大多数随机对照试验研究的是涉及颈部的临床症状表现的头痛，这些头痛可能更好地定义为“可能”、“可能”或“确定”的 CeH，具体取决于所使用的诊断标准与最新版（第 3 版）国际头痛疾病分类的一致性。
