Craniosacral Therapy in Migraine Feasibility Study

偏头痛的颅骶疗法可行性研究

• 批准号: 7143184
• 负责人: JOHN DOUGLAS MANN
• 金额: $ 29.2万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7143184
• 关键词: clinical research; clinical trials

DESCRIPTION (provided by applicant): Treatment of migraine continues to be a major health problem today, despite many new pharmacological therapies. Limited clinical experience suggests that craniosacral therapy (CST) may be effective in the treatment of headache, including migraine. The primary aim of this proposal is to gather quality preliminary data on the usefulness of CST as an adjunct to conventional care for patients with migraine and to determine the feasibility of a larger, randomized clinical trial of CST in patients with migraine. Craniosacral therapists use a technique of gentle palpation of the head, neck and spine to release restrictions in cranial and peri-spinal tissues that are believed to contribute to a variety of health problems including headache. It is estimated that more than 2 million visits to CST practitioners are made each year, with more than 10 per cent of those for the complaint of headache. There has been no rigorous research examining the usefulness of CST for patients with migraine despite the impression of beneficial effects. Our limited preliminary data show significant, sustained benefit of CST in a small group of patients with migraine. The First Specific Aim is to determine the feasibility of developing a clinical trial comparing craniosacral therapy versus low-strength static magnets (attention-control complementary therapy) as a treatment for preventing migraine headaches. Patients with migraine, with or without aura, under care of a neurologist will be studied. After an 8-week baseline period, they will be randomized to one of two groups: 1) usual medical care plus 8 weeks of CST; or 2) usual medical care plus 8 weeks of attention-control complementary treatment. Primary outcome measures will include: 1) headache-related quality of life, 2) headache frequency, and 3) perceived benefit in those receiving treatment. The Second Specific Aim is to identify relevant secondary outcomes associated with usual care plus adjunctive craniosacral therapy for migraine. Data collection will include demographics, headache intensity and duration, health status, headache-related disability, health care utilization, and medication use. The Third Specific Aim is to identify and find solutions for potential problems in conducting a larger clinical trial to assess the efficacy of CST for the prevention of migraine. Patients will be recruited from the University of North Carolina Headache Clinic and from local neurological practices. Duration of the study for each subject is 16 weeks. Length of the entire project is 2 years.

描述（由申请人提供）：尽管有许多新的药物疗法，但偏头痛的治疗仍然是当今的主要健康问题。有限的临床经验表明，颅骶疗法（CST）可能是有效的治疗头痛，包括偏头痛。本提案的主要目的是收集关于CST作为偏头痛患者常规护理的辅助手段的有用性的高质量初步数据，并确定在偏头痛患者中进行更大规模的CST随机临床试验的可行性。颅骶治疗师使用头部、颈部和脊柱的轻柔触诊技术来释放颅和脊柱周围组织的限制，这些组织被认为会导致包括头痛在内的各种健康问题。据估计，每年有200多万人次到儿童支助服务从业人员处就诊，其中10%以上是因为头痛。尽管CST对偏头痛患者有有益的效果，但还没有严格的研究来检查CST对偏头痛患者的有用性。我们有限的初步数据显示CST在一小群偏头痛患者中具有显著的持续获益。第一个具体目标是确定开发临床试验的可行性，比较颅骶疗法与低强度静态磁铁（注意力控制补充疗法）作为预防偏头痛的治疗方法。将对神经科医生治疗的偏头痛患者（有或无先兆）进行研究。在8周基线期后，他们将被随机分配到两组之一：1）常规医疗护理加8周CST;或2）常规医疗护理加8周注意力控制补充治疗。主要结果指标包括：1）头痛相关的生活质量，2）头痛频率，3）接受治疗的患者的感知获益。第二个具体目标是确定与偏头痛常规治疗加连续颅骶治疗相关的次要结局。数据收集将包括人口统计学、头痛强度和持续时间、健康状况、头痛相关残疾、医疗保健利用和药物使用。第三个具体目标是确定并找到解决方案，以进行更大规模的临床试验，以评估CST预防偏头痛的疗效。患者将从北卡罗来纳州头痛诊所和当地神经科诊所招募。每例受试者的研究持续时间为16周。整个项目的时间为2年。