Division of Preventive Medicine, Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.
John Graham Headache Center, Department of Neurology, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA.
Cephalalgia. 2021 Mar;41(3):318-328. doi: 10.1177/0333102420963844. Epub 2020 Oct 13.
Spinal manipulation may reduce migraine frequency, but effects of multimodal chiropractic care on migraine frequency have not been evaluated.
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.
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).
Pre-specified feasibility criteria were not met, but deficits were remediable. Preliminary data support a definitive trial of MCC+ for migraine.
This study is registered at Clinicaltrials.gov (NCT03177616).
脊柱推拿可能会降低偏头痛的发作频率，但多模式整脊治疗对偏头痛发作频率的影响尚未得到评估。
我们开展了一项试点随机对照试验，比较了多模式整脊治疗加增强常规护理（MCC+）与单纯增强常规护理（EUC）对发作性偏头痛成年女性的影响。EUC 包括常规医疗和偏头痛教育文献。MCC+ 组参与者接受了 10 次为期 14 周的整脊治疗。主要目的是评估招募、保留、方案依从性和安全性的可行性。偏头痛天数的变化是次要目标。
在 422 名筛选患者中，61 名在 20 个月内被随机分组。57 名（93%）患者在干预期间完成了偏头痛日记的每日记录，51 名（84%）完成了最终随访，45 名（74%）完成了所有评估。29 名 MCC+组参与者中的 24 名（83%）参加了>75%的整脊治疗。26 名患者（43%）报告了 98 例非严重不良事件，其中 11 名 EUC 参与者中有 39 例，15 名 MCC+参与者中有 59 例。MCC+组偏头痛天数减少（MCC+组减少 2.9 天，EUC 组减少 1.0 天，差值为-1.9；95%置信区间：-3.5，-0.4）。
未达到预先规定的可行性标准，但缺陷是可以纠正的。初步数据支持对 MCC+治疗偏头痛进行确证性试验。
本研究在 Clinicaltrials.gov 注册（NCT03177616）。
