Odell Jim, Clark Carol, Hunnisett Adrian, Ahmed Osman Hassan, Branney Jonathan
1Bournemouth University, Royal London House, Christchurch Road, Bournemouth, BH1 3LT UK.
2BPP University, McTimoney College, Kimber Road, Abingdon, OX14 1BZ UK.
Chiropr Man Therap. 2019 Mar 27;27:11. doi: 10.1186/s12998-019-0232-4. eCollection 2019.
Chronic migraine is a largely refractory condition affecting between 1 and 2.2% of the overall population worldwide, with females more affected than males. There are also high health and socioeconomic costs associated both for the individual and society. The mainstay of chronic migraine management is pharmacological, but the options available have limited efficacy and there are often unwanted side effects. There is some evidence for manual therapy as a treatment option for migraine, but its effectiveness for chronic migraine is unknown. Therefore, we have designed a pragmatic randomised control trial to investigate whether adding manual therapy to the tertiary specialist treatment of chronic migraine improves patient-reported outcomes.
A pragmatic, randomised controlled trial in a hospital tertiary headache clinic Participants will be randomised into one of two groups: treatment as usual or treatment as usual plus manual therapy. The primary outcome measure will be a change in the Headache Impact Test score. Secondary outcomes will also be measured over the 12-week study period including changes in headache frequency, migraine specific quality of life and reductions in relevant medicine consumption. The manual therapy group will have five treatment sessions each lasting 30 min. The recruitment target of 64 participants will allow power at 80% with = 0.05 using minimal clinical difference for Headache Impact Test of 3.7 and includes provision for a 10% dropout rate. Recruitment will take place between August 2018 and February 2019. The results will form part of a doctoral study and be published in peer-reviewed journals and presented at national/international conferences.
Current pharmacological approaches have limited effects in the management of chronic migraine and there is a requirement to improve treatment options and reduce the health and economic burden of the condition. Manual therapy has been shown to be effective in other chronic pain conditions as well as other primary headaches. This study will explore the effectiveness of manual therapy as an adjunctive approach to the management of chronic migraine.
The trial has received a favourable opinion from the UK Health Research Authority (IRAS 228901) and is registered at ClinicalTrials.gov.number NCT03395457. Registered 1st March 2018.
慢性偏头痛是一种难治性疾病，全球总体患病率为1%至2.2%，女性患病率高于男性。对个人和社会而言，其健康和社会经济成本也很高。慢性偏头痛管理的主要手段是药物治疗，但现有选择疗效有限，且往往伴有不良副作用。有证据表明手法治疗可作为偏头痛的一种治疗选择，但其对慢性偏头痛的有效性尚不清楚。因此，我们设计了一项实用的随机对照试验，以研究在慢性偏头痛的三级专科治疗中加入手法治疗是否能改善患者报告的结局。
在一家医院的三级头痛诊所进行一项实用的随机对照试验。参与者将被随机分为两组之一：常规治疗组或常规治疗加手法治疗组。主要结局指标将是头痛影响测试分数的变化。在为期12周的研究期间还将测量次要结局指标，包括头痛频率的变化、偏头痛特异性生活质量以及相关药物消耗量的减少。手法治疗组将进行五次治疗，每次持续30分钟。64名参与者的招募目标将使检验效能达到80%，α = 0.05，采用头痛影响测试的最小临床差异为3.7，并考虑10%的失访率。招募将于2018年8月至2019年2月进行。研究结果将作为博士研究的一部分发表在同行评审期刊上，并在国内/国际会议上展示。
目前的药物治疗方法在慢性偏头痛管理中的效果有限，需要改善治疗选择并减轻该疾病的健康和经济负担。手法治疗已被证明在其他慢性疼痛疾病以及其他原发性头痛中有效。本研究将探讨手法治疗作为慢性偏头痛管理辅助方法的有效性。
该试验已获得英国健康研究管理局的批准（IRAS 228901），并在ClinicalTrials.gov上注册，编号为NCT03395457。于2018年3月1日注册。
