颈椎源性头痛的脊柱推拿治疗的剂量-反应和疗效：一项双中心随机对照试验。
Dose-response and efficacy of spinal manipulation for care of cervicogenic headache: a dual-center randomized controlled trial.
机构信息
Integrative Health & Wellbeing Research Program, Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, 420 Delaware St SE, Minneapolis, MN 55455, USA.
Integrative Health & Wellbeing Research Program, Earl E. Bakken Center for Spirituality & Healing, University of Minnesota, 420 Delaware St SE, Minneapolis, MN 55455, USA.
出版信息
Spine J. 2018 Oct;18(10):1741-1754. doi: 10.1016/j.spinee.2018.02.019. Epub 2018 Feb 23.
BACKGROUND CONTEXT
The optimal number of visits for the care of cervicogenic headache (CGH) with spinal manipulative therapy (SMT) is unknown.
PURPOSE
The present study aimed to identify the dose-response relationship between visits for SMT and chronic CGH outcomes and to evaluate the efficacy of SMT by comparison with a light-massage control.
STUDY DESIGN/SETTING: This is a two-site, open-label randomized controlled trial.
PATIENT SAMPLE
Participants were 256 adults with chronic CGH.
OUTCOME MEASURES
The primary outcome was days with CGH in the previous 4 weeks evaluated at the 12- and 24-week primary end points. Secondary outcomes included CGH days at remaining end points, pain intensity, disability, perceived improvement, medication use, and patient satisfaction.
METHODS
Participants were randomized to four dose levels of chiropractic SMT: 0, 6, 12, or 18 sessions. They were treated three times per week for 6 weeks and received a focused light-massage control at sessions when SMT was not assigned. Linear dose effects and comparisons with the no-manipulation control group were evaluated at 6, 12, 24, 39, and 52 weeks. The present study was funded by the National Center for Complementary and Integrative Health (R01AT006330) and is registered at ClinicalTrials.gov (NCT01530321). The authors declare no conflicts of interest.
RESULTS
A linear dose-response was observed for all follow-ups, a reduction of approximately 1 CGH day/4 weeks per additional 6 SMT visits (p<.05); a maximal effective dose could not be determined. Cervicogenic headache days/4 weeks were reduced from about 16 to 8 for the highest and most effective dose of 18 SMT visits. Mean differences in CGH days/4 weeks between 18 SMT visits and control were -3.3 (p=.004) and -2.9 (p=.017) at the primary end points, and were similar in magnitude at the remaining end points (p<.05). Differences between other SMT doses and control were smaller in magnitude (p>.05). Cervicogenic headache intensity showed no important improvement nor differed by dose. Other secondary outcomes were generally supportive of the primary outcome.
CONCLUSIONS
There was a linear dose-response relationship between SMT visits and days with CGH. For the highest and most effective dose of 18 SMT visits, CGH days were reduced by half and about 3 more days per month than for the light-massage control.
背景
采用脊柱手法治疗（SMT）治疗颈源性头痛（CGH）的最佳就诊次数尚不清楚。
目的
本研究旨在确定 SMT 就诊次数与慢性 CGH 结局之间的剂量-反应关系，并通过与轻度按摩对照比较来评估 SMT 的疗效。
研究设计/地点：这是一项两站点、开放标签的随机对照试验。
患者样本
256 名患有慢性 CGH 的成年人。
主要结局指标
主要结局指标是在 12 周和 24 周的主要终点评估过去 4 周内 CGH 的天数。次要结局指标包括其余终点的 CGH 天数、疼痛强度、残疾、感知改善、药物使用和患者满意度。
方法
参与者被随机分配到四个整脊 SMT 剂量水平：0、6、12 或 18 次。他们每周接受三次治疗，持续 6 周，并在未进行 SMT 时接受集中的轻度按摩对照治疗。在第 6、12、24、39 和 52 周评估线性剂量效应，并与无操作对照组进行比较。本研究由国家补充与综合健康中心（R01AT006330）资助，并在 ClinicalTrials.gov 注册（NCT01530321）。作者声明没有利益冲突。
结果
在所有随访中均观察到线性剂量反应，每次额外 6 次 SMT 就诊可减少约 1 天/4 周的 CGH（p<.05）；无法确定最大有效剂量。在接受 18 次 SMT 治疗的最高和最有效剂量下，CGH 天/4 周从约 16 天减少到 8 天。在主要终点，18 次 SMT 治疗与对照组之间的 CGH 天/4 周的平均差异为-3.3（p=.004）和-2.9（p=.017），在其余终点差异相似（p<.05）。其他 SMT 剂量与对照组之间的差异较小（p>.05）。CGH 强度没有明显改善，也没有因剂量而异。其他次要结局通常支持主要结局。
结论
SMT 就诊次数与 CGH 天数之间存在线性剂量反应关系。在接受 18 次 SMT 治疗的最高和最有效剂量下，CGH 天数减少了一半，每月大约减少 3 天，比轻度按摩对照组减少了一半。
Zotero 插件