Integrative Migraine Pain Alleviation Through Chiropractic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change from baseline to the last four weeks of the intervention period in the number of migraine days.
研究概览
简要总结
This pilot study evaluates the addition of chiropractic treatment to conventional neurological care in the treatment of migraine headaches in adult women. Half of the participants will receive 10 chiropractic treatments in addition to their usual care over a 14 week period, while the other half will continue their usual medical care alone, as prescribed by their physician during that time period.
详细描述
Chiropractic care is a commonly used therapeutic intervention for the treatment of pain disorders, and some smaller studies have shown that it might be helpful for migraines. This pilot study will use a comprehensive model of chiropractic treatment which can include soft tissue mobilization, spinal manipulation, and postural and spinal stabilization and correctional exercises.
Specific Aims:
Aim #1 - Determine the feasibility of conducting a randomized control trial (RCT) of chiropractic care in adult women with migraine.
Aim #2 - To provide preliminary data on the safety and effectiveness of chiropractic care on migraine frequency, severity, duration, and medication use in adult women with migraine.
Aim #3 - To provide preliminary estimates of the effects of chiropractic on disability, health-related quality of life, and psychosocial well-being.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of episodic migraine with or without aura (International Classification of Headache Disorders-II)
- •4 to 13 days with migraines/month
- •More than one year of migraines
- •Agreeable to participate, commit to all study procedures, and to be randomized to either group
- •Fluent in English (required to complete self-report instruments)
排除标准
- •Currently, or having received chiropractic care in past 3 months for any condition
- •Any major systemic illness or unstable medical or psychiatric condition (e.g. Parkinson's disease, cancer) requiring immediate treatment or that could lead to difficulty complying with the protocol
- •History of stroke, carotid artery dissection, or vertebral artery dissection
- •Head or neck trauma within the past year
- •Diagnosis of medication overuse headache (International Classification of Headache Disorders-II)
- •Began use of new prophylactic medication for migraine headaches within the last 3 months
- •Currently taking prophylactic migraine medications other than propranolol and topiramate
- •Failure to complete baseline diary recordings of migraine activity and medication use during run-in phase
- •Currently, or having received Botox treatment for migraine
- •Current alcohol or substance abuse (self-reported)
- •Diagnosis of Ehlers-Danlos Syndrome
结局指标
主要结局
Change from baseline to the last four weeks of the intervention period in the number of migraine days.
时间窗: From the baseline period to week 11 through week 14.
Participants will record number of migraines experienced in provided logs.
次要结局
- Number of responders(From the baseline period to week 11 through week 14 and to week 15 through week 18.)
- Change from baseline in the Patient Reported Outcome Measures Information System -29 item questionnaire (PROMIS-29)(From baseline to 14 weeks and 18 weeks)
- Change from baseline in the severity of migraine(From the baseline period to week 11 through week 14 and to week 15 through week 18.)
- Change from baseline in the scores on the Migraine Disability Assessment (MIDAS)(From baseline to 14 weeks and 18 weeks)
- Change from baseline in the Generalized Anxiety Disorder 7-item (GAD-7)(From baseline to 14 weeks and 18 weeks)
- Change from baseline in the duration of migraine(From the baseline period to week 11 through week 14 and to week 15 through week 18.)
- Change from baseline in the doses of acute migraine medications used(From the baseline period to week 11 through week 14 and to week 15 through week 18.)
- Change from baseline in the Migraine Specific Quality of Life Questionnaire version 2.1 (MSQv2.1)(From baseline to 14 weeks and 18 weeks)
- Change from baseline in 9-item Patient Health Questionnaire (PHQ-9)(From baseline to 14 weeks and 18 weeks)
- Changes from baseline to the post-intervention period in the number of migraine days.(From the baseline period to week 15 through week 18.)
- Change from baseline in the scores on the Headache Impact Test (HIT-6) questionnaire(From baseline to 14 weeks and 18 weeks)
- Change from baseline in Numeric Rating Pain Scale (NRS)(From baseline to 14 weeks and 18 weeks)
研究者
Peter Wayne
Associate Professor of Medicine
Harvard University Faculty of Medicine