Muscle Soreness and Stiffness in Patients With Chronic or Frequent Episodic Tension Type Headache.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in Total Tenderness Score
研究概览
简要总结
The aim is to investigate muscle soreness and stiffness in patients with Chronic or Frequent Episodic Tension Type Headache before and after treatment with amitriptyline - and to compare the results with healthy individuals.
详细描述
The muscle stiffness is measured with ultrasonic shear wave elastography in m. masseter, m. sternocleidomastoid and m. Trapezius.
The muscle soreness is measured by palpation of the muscles aided by a so called palpometer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- 是
入选标准
- •Chronic Tension type headache or frequent episodic tension type headache with at least ten episodes or more per month throughout three months or more.
- •Pericranial muscle tenderness
排除标准
- •Other primary headache disorder (with the exception of episodic migraine.)
- •Pregnancy or ongoing breastfeeding
- •Heart disease that contradicts treatment with amitriptyline
- •Drug or substance abuse
研究组 & 干预措施
Tension type headache
The investigator measures the muscle soreness and muscle stiffness before the patients starts their prescribed treatment with amitriptyline - and again after they have reached their optimal dosage of amitriptyline.
干预措施: Amitriptyline (Drug)
结局指标
主要结局
Change in Total Tenderness Score
时间窗: March 2016 to march 2018. Up to 4 months.
The soreness of the muscle is reported by the patient on a scale from 0-3 (0= no pain, 1= mild pain, 2= moderate pain and 3= severe pain) when pressure is applied at eight different locations on both sides of the face and neck (m. masseter, m. frontalis, m. pterygoideus lateralis, m. temporalis, m. sternocleidomastoid, pros. mastoideus, m. trapezius and the insertions of the neck muscles at the base of the scull.) The sum of the individual scores make up the total tenderness.
Change in muscle stiffness
时间窗: March 2016 to march 2018. Up to 4 months.
The stiffness is measured in terms of the speed of the shear waves (meter/second) the higher the speed the stiffer the muscle.
Change in Local Tenderness Score
时间窗: March 2016 to march 2018. Up to 4 months.
Aided by a palpometer a pressure of 160 U is applied to four different locations (m. masseter, m. sternocleidomastoid, the lateral part of m. trapezius and the medial part of the m. trapezius.) At each location the patient report the pain intensity on a scale from 0-10.
次要结局
未报告次要终点
研究者
Lærke Tørring Kolding
Medical student
Danish Headache Center