Dose-Response of Manipulation for Cervicogenic Headache
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 256
- 试验地点
- 4
- 主要终点
- Headache days change from baseline for cervicogenic headache
研究概览
简要总结
This study will determine the number of visits to a chiropractor for spinal manipulation and light massage necessary for the optimal relief of cervicogenic headache (headache with associated neck pain). Effectiveness of care will also be determined.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic cervicogenic headache
- •threshold pain level
- •threshold headache frequency
- •independently ambulatory
- •English literate
- •candidate for spinal manipulation
排除标准
- •contraindication to thrust spinal manipulation or massage
- •most other headache types
- •Recent manual/exercise therapy from licensed provider for head/neck
- •threshold pain medication use
- •pregnancy
- •involvement with another pain study
- •suspicion of unmanaged depression
- •most cancers
- •hypertension (at least stage II)
- •complicating neurological/spinal conditions
- •pre-randomization noncompliance or cannot/will not comply with protocols
- •health-related litigation, claims, or disability compensation
研究组 & 干预措施
High dose spinal manipulation
18 visits for spinal manipulation
干预措施: Spinal Manipulation (Other)
Moderate dose spinal manipulation
12 visits for spinal manipulation and 6 visits for light massage
干预措施: Spinal Manipulation (Other)
Moderate dose spinal manipulation
12 visits for spinal manipulation and 6 visits for light massage
干预措施: Light Massage (Other)
Low dose spinal manipulation
6 visits for spinal manipulation and 12 visits for light massage
干预措施: Spinal Manipulation (Other)
Low dose spinal manipulation
6 visits for spinal manipulation and 12 visits for light massage
干预措施: Light Massage (Other)
High dose massage
18 visits for light massage
干预措施: Light Massage (Other)
结局指标
主要结局
Headache days change from baseline for cervicogenic headache
时间窗: 0, 6, 12, 24, 39, 52 weeks
Days with cervicogenic headache in the last four weeks from a daily headache diary. Change score = follow-up score - baseline score)
次要结局
- Outside Care change from baseline(0, 6, 12, 24, 39, 52 weeks)
- Quality-adjusted life years change from baseline(0, 12, 24, 39, 52 weeks)
- EuroQol-5D change from baseline(0, 12, 24, 39, 52 weeks)
- Neck pain days change from baseline(0, 6, 12, 24, 39, 52 weeks)
- Objective biomechanical measures change from baseline(0, 6 weeks)
- Headache-related disability days change from baseline(0, 6, 12, 24, 39, 52 weeks)
- medication use change from baseline(0, 6, 12, 24, 39, 52 weeks)
- Perceived headache average pain change from baseline for cervicogenic headache(0, 6, 12, 24, 39, 52 weeks)
- Average pain change from baseline for cervicogenic headache(0, 6, 12, 24, 39, 52 weeks)
- Headache-related disability change from baseline for cervicogenic headaches(0, 6, 12, 24, 39, 52 weeks)
- Average pain change from baseline for neck(0, 6, 12, 24, 39, 52 weeks)
- Patient Satisfaction(week 12)
- Direct & Indirect costs change from baseline(0, 6, 12, 24, 39, 52 weeks)
- Perceived headache improvement from baseline for cervicogenic headache(0, 6, 12, 24, 39, 52 weeks)
研究者
Mitchell Haas
Associate Vice President of Research
University of Western States