背景:物理治疗师广泛使用颈椎手法,脊医,骨科医生,和医生治疗颈部疼痛和颈源性头痛等肌肉骨骼功能障碍。宫颈手法的使用仍然存在争议,因为它通常被认为不仅是良性不良事件(AE)的风险,如疼痛或肌肉酸痛加重,还有严重的AE,如椎基底动脉或颈动脉夹层后的中风。发现宫颈操作与严重AE(如动脉夹层)之间存在关联的研究主要是病例对照研究或病例报告。这些研究设计不适合调查发病率,因此并不意味着因果关系。随机对照试验(RCT)被认为是评估益处和危害的无混淆效果的黄金标准研究设计。例如AE,与治疗相关。
目标:由于与高速相关的不良事件的风险水平不明确,低振幅(HVLA)颈椎手法,本研究的目的是从RCT中提取可用信息,从而综合宫颈操作后AE的风险与各种对照干预措施的风险比较.
方法:系统评价和荟萃分析。
方法:在PubMed和Cochrane数据库中进行了系统的文献检索。该搜索包括应用宫颈HVLA操作并报告AE的RCT。两名独立的审核员进行了研究选择,方法学质量评估,和等级方法。计算发生率比(IRR)。使用偏倚风险2(RoB-2)工具评估研究质量,并使用等级方法确定证据的确定性。
结果:系统评价和荟萃分析纳入了14篇文献。合并的IRR表明操作组和对照组之间没有统计学上的显着差异。所有报告的不良事件被归类为轻度,报告的不良事件无严重或中度。
结论:搜索策略仅限于英语或德语文献。此外,可能发生了选择偏差,因为只有PubMed和Cochrane被用作数据库,搜索是手工完成的。如果结果不表明发生AE的组,则必须排除RCT。纳入荟萃分析的强制性标准是可归因于特定干预措施的AE频率的定量再现。
结论:总之,与各种对照干预措施相比,HVLA操作不会增加轻度或中度AE的风险。然而,这些结果必须谨慎解释,由于RCT不适合检测罕见的严重AE。此外,未来的RCT应遵循临床试验中报告AE的标准化方案.
BACKGROUND: Cervical manipulations are widely used by physiotherapists, chiropractors, osteopaths, and medical doctors for musculoskeletal dysfunctions like neck pain and cervicogenic headache. The use of cervical manipulation remains controversial, since it is often considered to pose a risk for not only benign adverse events (AEs), such as aggravation of pain or muscle soreness, but also severe AEs such as strokes in the vertebrobasilar or carotid artery following dissections. Studies finding an association between cervical manipulation and serious AEs such as artery dissections are mainly case control studies or case reports. These study designs are not appropriate for investigating incidences and therefore do not imply causal relationships. Randomized controlled trials (RCTs) are considered the gold standard study designs for assessing the unconfounded effects of benefits and harms, such as AEs, associated with therapies.
OBJECTIVE: Due to the unclear risk level of AEs associated with high-velocity, low-amplitude (HVLA) cervical manipulation, the aim of this study was to extract available information from RCTs and thereby synthesize the comparative risk of AEs following cervical manipulation to that of various control interventions.
METHODS: Systematic review and meta-analysis.
METHODS: A systematic literature search was conducted in the PubMed and Cochrane databases. This search included RCTs in which cervical HVLA manipulations were applied and AEs were reported. Two independent reviewers performed the study selection, the methodological quality assessment, and the GRADE approach. Incidence rate ratios (IRR) were calculated. The study quality was assessed by using the risk of bias 2 (RoB-2) tool, and the certainty of evidence was determined by using the GRADE approach.
RESULTS: Fourteen articles were included in the systematic review and meta-analysis. The pooled IRR indicates no statistically significant differences between the manipulation and control groups. All the reported AEs were classified as mild, and none of the AEs reported were serious or moderate.
CONCLUSIONS: The search strategy was limited to literature in English or German. Furthermore, selection bias may have occurred, since only PubMed and Cochrane were used as databases, and searching was done by hand. RCTs had to be excluded if the results did not indicate the group in which the AEs occurred. A mandatory criterion for inclusion in the meta-analysis was a quantitative reproduction of the frequencies of AEs that could be attributed to specific interventions.
CONCLUSIONS: In summary, HVLA manipulation does not impose an increased risk of mild or moderate AEs compared to various control interventions. However, these results must be interpreted with caution, since RCTs are not appropriate for detecting the rare serious AEs. In addition, future RCTs should follow a standardized protocol for reporting AEs in clinical trials.