Chaibi Aleksander, Benth Jūratė Šaltytė, Tuchin Peter J, Russell Michael Bjørn
Head and Neck Research Group, Research Centre, Akershus University Hospital, 1478 Lørenskog, Norway ; Institute of Clinical Medicine, Akershus University Hospital, University of Oslo, 1474 Nordbyhagen, Norway.
Institute of Clinical Medicine, Akershus University Hospital, University of Oslo, 1474 Nordbyhagen, Norway ; HØKH, Research Centre, Akershus University Hospital, Lørenskog, Norway.
Springerplus. 2015 Dec 16;4:779. doi: 10.1186/s40064-015-1567-5. eCollection 2015.
Cervicogenic headache (CEH) is a secondary headache which affects 1.0-4.6 % of the population. Although the costs are unknown, the health consequences are substantial for the individual; especially considering that they often suffers chronicity. Pharmacological management has no or only minor effect on CEH. Thus, we aim to assess the efficacy of chiropractic spinal manipulative therapy (CSMT) for CEH in a single-blinded placebo-controlled randomized clinical trial (RCT). According to the power calculations, we aim to recruit 120 participants to the RCT. Participants will be randomized into one of three groups; CSMT, placebo (sham manipulation) and control (usual non-manual management). The RCT consists of three stages: 1 month run-in, 3 months intervention and follow-up analyses at the end of intervention and 3, 6 and 12 months. Primary end-point is headache frequency, while headache duration, headache intensity, headache index (frequency × duration × intensity) and medicine consumption are secondary end-points. Primary analysis will assess a change in headache frequency from baseline to the end of intervention and to follow-up, where the groups CSMT and placebo and CSMT and control will be compared. Due to two group-comparisons, the results with p values below 0.025 will be considered statistically significant. For all secondary end-points and analyses, the significance level of 0.05 will be used. The results will be presented with the corresponding p values and 95 % confidence intervals. To our knowledge, this is the first prospective manual therapy three-armed single-blinded placebo-controlled RCT to be conducted for CEH. Current RCTs suggest efficacy in headache frequency, duration and intensity. However a firm conclusion requires clinical single-blinded placebo-controlled RCTs with few methodological shortcomings. The present study design adheres to the recommendations for pharmacological RCTs as far as possible and follows the recommended clinical trial guidelines by the International Headache Society. Trial registration ClinicalTrials.gov identifier: NCT01687881, 2 December 2012.
颈源性头痛（CEH）是一种继发性头痛，影响着1.0%-4.6%的人群。尽管费用未知，但对个体的健康影响很大；尤其是考虑到这种头痛常常会发展为慢性。药物治疗对颈源性头痛没有效果或仅有轻微效果。因此，我们旨在通过一项单盲安慰剂对照随机临床试验（RCT）来评估整脊脊柱手法治疗（CSMT）对颈源性头痛的疗效。根据功效计算，我们计划招募120名参与者参加该RCT。参与者将被随机分为三组之一：CSMT组、安慰剂组（假手法治疗）和对照组（常规非手法治疗）。该RCT包括三个阶段：1个月的导入期、3个月的干预期以及在干预期结束时、3个月、6个月和12个月时的随访分析。主要终点是头痛频率，而头痛持续时间、头痛强度、头痛指数（频率×持续时间×强度）和药物消耗量是次要终点。主要分析将评估从基线到干预期结束以及随访时头痛频率的变化，并对CSMT组与安慰剂组以及CSMT组与对照组进行比较。由于进行了两组比较，p值低于0.025的结果将被视为具有统计学意义。对于所有次要终点和分析，将使用0.05的显著性水平。结果将呈现相应的p值和95%置信区间。据我们所知，这是第一项针对颈源性头痛进行的前瞻性手法治疗三臂单盲安慰剂对照RCT。目前的RCT表明在头痛频率、持续时间和强度方面有疗效。然而，要得出确凿结论需要进行方法学缺陷较少的临床单盲安慰剂对照RCT。本研究设计尽可能遵循药物RCT的建议，并遵循国际头痛协会推荐的临床试验指南。试验注册ClinicalTrials.gov标识符：NCT01687881，2012年12月2日。
