Wolff Moa, Winnberg Ingunn, Tronvik Erling, Bakhsheshi Mohammad F, Midlov Patrik
Department of Clinical Sciences, Lund University, Malmö, SWE.
Department of Neuromedicine and Movement Science, St. Olavs University Hospital, Trondheim, NOR.
Cureus. 2024 Nov 3;16(11):e72911. doi: 10.7759/cureus.72911. eCollection 2024 Nov.
A significant proportion of people with migraine do not achieve sufficient relief of their acute migraine symptoms with the currently available medications. A previous study showed that intranasal evaporative cooling reduced headache and migraine-associated symptoms when given in an outpatient clinic setting. This study aimed to evaluate the feasibility of self-administering the same intervention for acute migraine in an at-home setting. The findings of this study were intended to inform the design and implementation of a planned full-scale randomized controlled trial (RCT).
We conducted a prospective single-group clinical feasibility trial in southern Sweden. Participants meeting the criteria for episodic migraine, with or without aura, were recruited through local advertisements. After a screening period, during which two migraine attacks were registered and evaluated under usual care, participants treated their next three migraine attacks at home with 10 minutes of intranasal cooling (RhinoChill®, BrainCool AB, Lund, Sweden). The primary outcome was a reduction in headache, nausea, photophobia, and phonophobia immediately after treatment. The secondary outcome was tolerability, and treatment effects within 24 hours.
Six out of 15 participants completed the study, using the cooling treatment for three consecutive migraine attacks. The main reasons for drop-out were pain/discomfort from treatment and lack of effect. A total of 23 treatments were registered by 10 participants. Small effects on pain and other migraine symptoms were observed immediately after treatment. The treatment was considered very unpleasant (Visual Analogue Scale 7.3/10) and not superior to usual care.
The RhinoChill® intranasal cooling treatment at home was found to be non-feasible due to pain and discomfort, resulting in a high drop-out rate. Additionally, it had only minor effects on migraine pain and symptoms. The findings of this study led to the cancellation of a planned full-scale RCT.
相当一部分偏头痛患者使用现有药物无法充分缓解急性偏头痛症状。此前一项研究表明，在门诊环境中给予鼻内蒸发冷却可减轻头痛及偏头痛相关症状。本研究旨在评估在家庭环境中自我实施相同干预措施治疗急性偏头痛的可行性。本研究结果旨在为一项计划中的大规模随机对照试验（RCT）的设计和实施提供参考。
我们在瑞典南部进行了一项前瞻性单组临床可行性试验。通过当地广告招募符合发作性偏头痛标准（有或无先兆）的参与者。在筛选期内，记录并在常规护理下评估两次偏头痛发作，之后参与者在家中使用鼻内冷却10分钟（RhinoChill®，BrainCool AB，瑞典隆德）治疗接下来的三次偏头痛发作。主要结局是治疗后立即出现的头痛、恶心、畏光和畏声减轻情况。次要结局是耐受性以及24小时内的治疗效果。
15名参与者中有6名完成了研究，连续使用冷却疗法治疗了三次偏头痛发作。退出的主要原因是治疗引起的疼痛/不适以及无效。10名参与者共记录了23次治疗。治疗后立即观察到对疼痛和其他偏头痛症状有轻微影响。该治疗被认为非常不舒服（视觉模拟评分7.3/10），且并不优于常规护理。
由于疼痛和不适，在家中使用RhinoChill®鼻内冷却治疗不可行，导致高退出率。此外，它对偏头痛疼痛和症状只有轻微影响。本研究结果导致计划中的大规模RCT取消。
