Background

Spinal manipulation may reduce migraine frequency, but effects of multimodal chiropractic care on migraine frequency have not been evaluated.

Methods

We conducted a pilot randomized controlled trial comparing multimodal chiropractic care + enhanced usual care (MCC+) versus enhanced usual care alone (EUC) among adult women with episodic migraine. EUC was comprised of usual medical care and migraine education literature. MCC+ participants received 10 sessions of chiropractic care over 14 weeks. Primary aims evaluated feasibility of recruitment, retention, protocol adherence, and safety. Change in migraine days was a secondary aim.

Results

Of 422 patients screened, 61 were randomized over 20 months. Fifty-seven (93%) completed daily migraine logs during the intervention, 51 (84%) completed final follow-up, and 45 (74%) completed all assessments. Twenty-four of 29 MCC+ participants (83%) attended > 75% of the chiropractic sessions. Ninety-eight non-serious adverse events were reported by 26 participants (43%) with 39 events among 11 EUC participants and 59 events among 15 MCC+ participants. MCC+ participants experienced greater reductions in migraine days (−2.9 days for MCC+ vs. −1.0 days for EUC, difference = −1.9; 95% confidence interval: −3.5, −0.4).

Conclusions

Pre-specified feasibility criteria were not met, but deficits were remediable. Preliminary data support a definitive trial of MCC+ for migraine.

Trial Registration

This study is registered at Clinicaltrials.gov (NCT03177616).

中文翻译：

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偏头痛的多模式脊椎按摩治疗：一项试点随机对照试验

背景

脊柱推拿可以减少偏头痛的频率，但尚未评估多模式脊椎按摩治疗对偏头痛频率的影响。

方法

我们进行了一项随机对照试验，在患有发作性偏头痛的成年女性中比较多模式脊椎按摩治疗 + 强化常规护理 (MCC+) 与单独强化常规护理 (EUC)。EUC 由常规医疗和偏头痛教育文献组成。MCC+ 参与者在 14 周内接受了 10 次脊椎按摩治疗。主要目标评估招募、保留、协议遵守和安全性的可行性。偏头痛天数的变化是次要目标。

结果

在筛选的 422 名患者中，有 61 名在 20 个月内被随机分配。57 人 (93%) 在干预期间完成了每日偏头痛记录，51 人 (84%) 完成了最终随访，45 人 (74%) 完成了所有评估。29 名 MCC+ 参与者中有 24 名 (83%) 参加了 > 75% 的脊椎按摩疗法课程。26 名参与者 (43%) 报告了 98 起非严重不良事件，其中 11 名 EUC 参与者中有 39 起事件，15 名 MCC+ 参与者中有 59 起事件。MCC+ 参与者的偏头痛天数减少更多（MCC+ 为 -2.9 天，EUC 为 -1.0 天，差异 = -1.9；95% 置信区间：-3.5，-0.4）。

结论

未达到预先指定的可行性标准，但缺陷是可以补救的。初步数据支持 MCC+ 治疗偏头痛的最终试验。

试用注册

本研究已在 Clinicaltrials.gov (NCT03177616) 上注册。