Changes in Intracranial Compliance in Migraine Subjects Following a National Upper Cervical Chiropractic Association (NUCCA)Atlas Correction Intervention - a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in intracranial compliance; comparing the baseline period to one month post treatment, 4 weeks after initiation of NUCCA care and maintained correction of atlas misalignment, as measured by phase contrast magnetic resonance imaging.
研究概览
简要总结
A small number of chiropractors, who align only the atlas C-1, or "top" vertebra in the spine, practice the National Upper Cervical Chiropractic Association (NUCCA) atlas correction procedure. This procedure uses a precise, non-invasive, gentle touch technique to correct misalignment of the atlas. Although NUCCA practitioners have long used this procedure in the treatment of headache, it has not been formally studied using clinical trials. There is some data indicating that NUCCA correction can increase intracranial compliance. This intracranial compliance can be measured by a magnetic resonance imaging (MRI) study before and then after a NUCCA procedure. In this study, the investigators hope to show that the correction of an atlas misalignment will increase intracranial compliance in subjects with migraine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be 18-65 years of age.
- •Be naive to Upper Cervical Chiropractic care. Other forms of chiropractic care in the past are permitted.
- •Have migraine with or without aura.
- •Have between 10-26 headache days per month over the last 4 months.
- •Have at least 4 separate headache episodes per month, with episodes separated by at least 4 hours of painfree time.
- •Have at least 8 days per month with pain of levels greater than or equal to 4/10 for part of the day, or have attacks successfully treated with migraine specific medication.
- •Be candidates suitable for NUCCA therapeutic intervention because of atlas displacement as assessed by NUCCA investigator.
- •Subjects on acceptable pharmacological prophylaxis must either remain on a stable dose throughout the study, or stop the prophylactic medication one month before entering the baseline period.
排除标准
- •Any medical or psychiatric condition which in the opinion of the investigator would make the subject unsuitable for enrolment, because of inability to comply with study requirements or possible confounding of the results.
- •Headache on more than 26 days per month.
- •Acute medication overuse as defined by the International Classification of Headache Disorders.
- •Pregnancy or lactation
- •Severe cervical spine degeneration as assessed by cervical spine x-ray.
- •Claustrophobia or any condition that contraindicates an MRI scan
- •A history of cardiovascular disease, cerebrovascular disease, brain surgery, or other central nervous system disorder.
- •Other chronic pain disorder which might interfere with headache assessment or study procedures.
- •A history of significant hypo- or hypertension as determined by the investigator.
- •Subject on a beta-blocker, calcium channel blocker, or other medication which the investigator considers might alter cerebral vascular regulation. Triptans are allowed, but must not be taken within 24 hours (48 hours for frovatriptan) before an MRI study.
- •A history of substance abuse or dependence within 1 year.
- •Current participation in a research study or within the last 30 days.
- •Any spinal chiropractic care outside of the study protocol is prohibited during the baseline and treatment period.
- •Use of botulinum A within 4 months of study entry.
- •A history of significant head or neck trauma (as judged by the investigator) within the year prior to study entry.
结局指标
主要结局
Change in intracranial compliance; comparing the baseline period to one month post treatment, 4 weeks after initiation of NUCCA care and maintained correction of atlas misalignment, as measured by phase contrast magnetic resonance imaging.
时间窗: At baseline, at 4 weeks, at 8 weeks
次要结局
- Average headache intensity on headache days(At baseline, at 4 weeks, at 8 weeks)
- Days with headache per month(At baseline, at 4 weeks, at 8 weeks)
研究者
Dr. Werner Becker
Dr. Werner Becker, MD, FRCPC
University of Calgary