Effects of Specific Neck Rehabilitation on Patients With Unilateral Headache and Neck Pain (Cervicogenic Headache), and Relation to Structural and Functional Changes in the Brain
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Difference of days with headache pr week after specific neck rehabilitation vs standard primary health care
研究概览
简要总结
In part 1 of the project clinical effect of specific neck rehabilitation for unilateral headache and neck pain (also termed cervicogenic headache) will be compared with standard primary health care. The researchers will further study whether fear avoidance beliefs and self-efficacy predict long term neck function and headache frequency superior to active range of neck movement. Part 2 will investigate whether patients with cervicogenic headache have structural changes in cerebral grey and white matter and in connectivity of the resting state state network, and whether these are reversed after effective neck rehabilitation and correlate to symptom severity and degree of disability.
详细描述
The project includes two parts:
Part 1: With a longitudinal semicross-over, randomized control design the investigators will compare the clinical efficacy of a 6 month specific neck rehabilitation with standard primary health care on patients with unilateral headache and neck pain ( also termed cervicogenic headache) and study whether self-efficacy and fear avoidance beliefs predict 12 month self-reported neck function and headache frequency superior to the active range of neck movement The patients will either receive a specific neck rehabilitation program or 6 month standard primary health care before they cross over to neck rehabilitation. Sociodemographic and clinical characteristics will be collected before each treatment session and 6 and 12 months later.
Part 2: With a non-randomized comparative design including a subsample of the patients (n: 36) and healthy controls (n: 36) the investigators will explore whether there are structural changes in the cerebral grey and white matter, and whether cerebral connectivity within the default mode network (DMN and other major cerebral networks) are significantly different and whether the changes correlate to symptom severity and degree of disability.
Structural (cortical volume and thickness) changes will measured by volumetric magnetic resonance imaging (MRi) and diffusion tensor imaging (DTI), while cerebral connectivity by resting state fMRI (rs-fMRI). Whether the anticipated cerebral changes in volume, structure and connectivity are reversed after specific neck rehabilitation will be tested by repeated measurements. Analyses of MRI scans and clinical characteristics will be performed before each treatment session and 6 months later.
Statistics: A parallel design power calculations based on previous studies indicated that for the clinical part a number of 21 patients within each treatment group (a total of 42 patients) and for the MR analyses a subsample of 34 patients and 34 health controls will be sufficient to obtain a statistical power of 80% with a p-value of 5%. Given a 2:1 ratio following a semi-cross over design, normal distributed data, α = 0.05, different standard deviations for each group (SD 1,38 and 1,71), and a statistical power of 0,8, a calculation indicated a sample size of 36 patients for the RCT. With a dropout rate up to 35%, 54 participants would be satisfactory.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral headache and neck pain for 2 years or more
- •Minimum one headache attack pr week (numeric rating scale ≥4)
- •Five or more of Antonaci's seven diagnostic criteria
- •Neck Disability Index score ≥8 Points (≥16 percent points).
- •For healthy controls:
- •Same age distribution
排除标准
- •Progressive diseases (rheumatoid arthritis, cancer)
- •Ongoing cervical infection
- •Neurological disease (syringomyelia, radiculopathy, multiple sclerosis, Parkinson's disease, ischemic stroke )
- •Other headache (>1 tension type headache or migraine attack every month)
- •Other pain conditions (including primary temporomandibular disorder and generalized pain (fibromyalgia with pain intensity >6 to digital palpation)
- •Previous or ongoing drug abuse
- •Serious psychiatric disorder.
- •Hopkins Symptom Checklist-25 score for depressive symptoms > 2.2
- •Ongoing litigation process
- •Intolerance to MRI
- •Pregnancy and lactation
- •For the subsample undergoing MR analyses: Other systemic diseases (Hypertension, hyperlipidemia, diabetes mellitus, heart disease, cerebrovascular, epilepsy or other vascular diseases) and dysmenorrhea requiring analgesics
- •For healthy controls:
- •Exclusion criteria as above
- •Chronic pain
- •Chronic dizziness
- •Intolerance to MRI
- •Pregnancy and lactation
研究组 & 干预措施
Specific neck rehabilitation
The intervention includes specific neck rehabilitation as described by Jull and Falla over a period of 4 weeks and recommendations for further training.
干预措施: Specific neck rehabilitation (Behavioral)
Standard primary health care
This represents individualized therapy administered by the primary physician.
干预措施: Standard primary health care (Other)
结局指标
主要结局
Difference of days with headache pr week after specific neck rehabilitation vs standard primary health care
时间窗: 6 months after baseline
Between group comparison with a numeric variable (scale 0-7)
Differences in grey matter volume of the brain and brain stem between patients with unilateral headache and neck pain vs. healthy controls
时间窗: Baseline
Two independent group comparison based on volumetric analysis of cerebral grey matter also including surface based measurements (continuous variable)
Differences in cortical thickness between patients with unilateral headache and neck pain vs. healthy controls
时间窗: Baseline
Two independent group comparison based on surface based analyses of cerebral grey matter carried out with FreeSurfer version 6.0
次要结局
- Differences in white matter integrity in patients with unilateral headache and neck pain vs. healthy controls(Baseline)
- Difference in white matter integrity after specific neck rehabilitation vs standard primary health care(6 months after baseline)
- Change in grey matter volume of the brain and brain stem in patients with unilateral headache and neck pain after specific neck rehabilitation(6 months)
- Difference in pain intensity after specific neck rehabilitation vs. standard primary health care(6 months after baseline)
- Improved neck function after specific neck rehabilitation vs. standard primary health care(6 months after baseline)
- Change in cortical thickness of the brain between patients with unilateral headache and neck pain after specific neck rehabilitation(6 months)
- How four week baseline headache intensity reported by a numeric rating scale is associated with regional grey matter volumes measured by surface based volumetry in patients with unilateral headache and neck pain.(Baseline)
- How baseline perceived cognitive function predicts volumetric differences of cerebral grey matter in patients with unilateral headache and neck pain(Baseline)
- How baseline active range of neck movement predicts neck function(12 months after baseline)
- How baseline self efficacy predicts neck function(12 months after baseline)
- How baseline self efficacy predicts headache frequency(12 months after baseline)
- How baseline fear avoidance beliefs for physical activity predict neck function(12 months after baseline)
- How baseline fear avoidance beliefs for physical activity predict headache frequency(12 months after baseline)
- Difference in intra-network connectivity of resting state networks in patients with unilateral headache and neck pain vs. healthy controls.(Baseline)
- Change of resting state connectivity in patients who report reduction in headache attacks.(6 months after baseline)
- Changes of resting state connectivity related to pain relief after specific neck rehabilitation.(6 months)
- Changes in connectivity of resting state networks related to improved craniocervical flexion endurance capacity after specific neck rehabilitation.(6 months)
- How baseline active range of neck movement predicts headache frequency(12 months after baseline)