Short- and Mid-Term Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache. A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Headache Intensity (HIT-6)
研究概览
简要总结
Cervicogenic headache is defined as unilateral headache associated with neck pain. Effect of manual translatoric therapy of the upper cervical spine associated with cervical exercises in these patients is currently unknown. Our aim was to determine if adding manual therapy to an exercise and home-exercise program improved effects on symptoms and function in short- and mid-term in patients with cervicogenic headache.
A randomized controlled study will be conducted with 40 subjects with cervicogenic headache. Each group will receive four 20-minute sessions weekly and a home-exercise program. Upper cervical flexion, flexion-rotation test, Impact Headache Test-6 (HIT-6), headache intensity, craniocervical flexion test, pain pressure thresholds and Global Rating of Change (GROC)-Scale will be assessed at end of the intervention, at 3- and at 6-month follow-ups.
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
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of cervicogenic headache according to Sjaastad et al. Subjects will have to fulfill both parts I and III of the major criteria for diagnosis (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region)
- •Hypomobility in one or more segments of C0-1, C1-2, C2-3 through manual evaluation.
- •A positive result in the flexion-rotation test.
- •A failure to pass stage 2 (24 mmHg) of the craniocervical flexion test.
- •Be at least 18 years old.
- •Have signed the informed consent.
排除标准
- •Contraindications for manual therapy or exercise.
- •Participation in exercise or manual therapy programs in the last three months.
- •Inability to maintain supine position.
- •The use of pacemakers (the magnets in the CROM device could alter their signal).
- •Inability to perform the flexion-rotation test.
- •Language difficulties.
- •Pending litigation or lawsuits.
结局指标
主要结局
Headache Intensity (HIT-6)
时间窗: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Test-6 questionnaire (HIT-6) will be used to describe the degree of pain and disability caused by the headache, with a reliability higher than 0.70. The results are classified into four categories that score daily life impact of headache (little or none, some, substantial and severe.
Flexion-rotation test
时间窗: Change between baseline and post intervention (1 month), after 3 months and after 6 months
This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32º
次要结局
- Craniocervical flexion test(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Global Raiting of Scale (GROC-Scale)(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Upper cervical flexion range of motion(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Headache Intensity(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Adherence to self-treatment scale(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Pain Pressure Thresholds(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
研究者
Jacobo Rodríguez-Sanz
Principal Investigator
Universidad de Zaragoza