Effectiveness of a Novel Device for Cervical Training in Cervicogenic Headache. Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Flexion Rotation Test (FRT)
研究概览
简要总结
The purpose of this study is to evaluate the clinical results in cervical spine range of motion, endurance deep cervical muscles, headache impact and physical activity enjoyment by a training protocol with the new device for cervical treatment (CDAT) versus conventional training protocol (CT) in subjects with cervicogenic headache.
详细描述
The cervical spine is the most mobile region of the spine and must be strong enough to support the weight of the skull. Strength deficits of the deep cervical muscles are related to different clinical conditions, such as cervicogenic headache. Cervicogenic headache is a secondary headache defined as a unilateral headache associated with neck pain, related to a decreased cervical range of motion and strength deficits of the deep cervical muscles.
Training protocols can help to improve pain, function, posture and cross-sectional area. However, there are no training protocols in subjects with cervicogenic headache including deep neck extensor and flexor muscles. The cervical device treatment (CDAT) allows us to train the cervical flexor and extensor muscle in a simple and comfortable way.
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
- Double (Participant, Outcomes Assessor)
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
- •Deep flexor strength deficit in craniocervical flexion test.
- •Deep extensor strength deficit in neck extensor muscle endurance.
- •A positive result in the flexion-rotation test
- •≥ 50 score in Headache Impact Test (HIT-6).
- •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)
排除标准
- •Have received head/cervical treatment during the last six month, presented any red flag, neurological or cognitive impairment (inability to understand the questionnaires or examination).
- •Have received cervical manual therapy treatment during the last six month
- •A history of head/cervical trauma or surgery during the last year.
- •The use of pacemakers (the magnets in the CROM device could alter their signal
- •Inability to perform the flexion-rotation test.
研究组 & 干预措施
Experimental: Training protocol with the cervical device for treatment (CDAT).
Endurance training program of deep cervical flexors and deep cervical extensors with the cervical device for treatment.
干预措施: Training protocol with the cervical device for treatment (CDAT). (Other)
Conventional training protocol
Endurance training program of deep cervical flexors and deep cervical extensors with the conventional protocol.
干预措施: Conventional training protocol (Other)
结局指标
主要结局
Change in Flexion Rotation Test (FRT)
时间窗: Change between baseline and post intervention (6 weeks) and after 10 weeks.
Mean change from baseline in Flexion-rotation test after 6 weeks and 10 weeks. The examiners assess the cervical ROM using CROM (Cervical Range-of-Motion Instrument). Flexion rotation test will be evaluated. Flexion rotation 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 32.
Change in Headache Impact Test (HIT-6) (Headache Disfunction)
时间窗: Change between baseline and post intervention (6 weeks) and after 10 weeks.
Mean change from baseline in Headache Impact Test (HIT-6) after 6 weeks and 10 weeks. The examiners assess the impact of headache on patients' lives using the HIT-6. Very severe impact: 60 or more. Major impact: 56-59 score Some impact: 50-55 score Little or no impact: 49 or less.
次要结局
- Deep neck flexor endurance Test.(Baseline and 6 weeks, 10 weeks.)
- Craniocervical flexion test(Baseline and 6 weeks, 10 weeks.)
- Cervical Spine Range of Motion (ROM).(Baseline and 6 weeks, 10 weeks.)
- Physical activity enjoyment Scale (PACES)(6 weeks)
研究者
Pilar Pardos Aguilella
Colaborator Lecturer in Physiotherapy
Universitat Internacional de Catalunya