Efficacy of Manual Therapy in Tension-type Headache Patients With Neck Pain: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Headache Frequency (HF)
研究概览
简要总结
Tension-type headache (TTH) causes a significant negative impact on working and daily life due to the reduction in work productivity and family and social activities causes. There is evidence that manual therapy and exercise reduce nociceptive input from the cervical spine and surrounding muscles, the use of manual therapy in TTH management
详细描述
Increased cranio-cervical muscle sensitivity is the most prominent finding in TTH. Also, neck pain is markedly more common in individuals with TTH compared with the control population (88.4%, and 56.7%, respectively). Therefore, current research on the pathogenesis of TTH focuses on the role of musculoskeletal disorders in the cervical spine and the facilitation of nociceptive pain processing. It has been suggested that peripheral sensitivity of nociceptors in cranio-cervical muscles and other cervical structures, as well as sensitivity of nociceptive pain pathways in the central nervous system (CNS) due to long-term nociceptive stimuli may play a role in development and chronification of TTH
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of TTH was made based on the International Classification of Headache Disorders criteria, third edition (ICHD-3 beta)
- •(bilateral localization, pressing and tightening pain, mild-moderate intensity [≤7.0 on a visual analog scale (VAS)]
- •no increase in pain during physical activity
- •patients did not report any photophobia, phonophobia, vomiting or nausea, as requested by the ICHD-III diagnostic criteria
- •had symptoms for more than 3 months
- •the patients had to have had at least one segmental dysfunction of the upper cervical spine in all groups (by functional and pain-provocation tests).
排除标准
- •any other primary or secondary headache according to the ICHD-III criteria
- •a history of neck or head trauma (e.g., whiplash)
- •any red flags (vertebral tumor, fracture, dislocation and infection, metabolic diseases, rheumatic and connective tissue diseases, systemic neuromuscular diseases, prolonged history of steroid use)
- •diagnosis of any structural spinal disorders (osteoporosis, disc herniation, myelopathy, spinal stenosis, spondylolisthesis)
- •prior surgery to the cervical spine
- •application of other treatment methods such as physical therapy or anesthetic block to the head and neck area within the last 3 months
- •initiation of pharmacologic prophylaxis within two months prior to randomization
- •pregnancy
结局指标
主要结局
Headache Frequency (HF)
时间窗: Changes from baseline in Headache Frequency Score to 1 month and 3 months
. Headache frequency was measured as the total number of days with headache (days/2-week) in the previous 2 weeks.
次要结局
- Visual Analog Scale (VAS)(Changes from baseline in Visual Analog Scale Score to 1 month and 3 months)
- Headache Impact Test-6 (HIT-6)(Changes from baseline in Headache Impact Test-6 Score to 1 month and 3 months)
- Neck Disability Index (NDI)(Changes from baseline in Neck Disability Index Score to 1 month and 3 months)
- Pressure-Pain Threshold (PTT)(Changes from baseline in Pressure-Pain Threshold Score to 1 month and 3 months)
研究者
Mustafa Corum
Principal Investigator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital