Examination of Muscle Stiffness, Tenderness and Pressure Pain Thresholds During a Cycle of Botulinum Toxin A Treatment in Chronic Migraine Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in total tenderness score
研究概览
简要总结
Preventive treatment with botulinum toxin A injections is standard care for chronic migraine and follows the PREEMPT protocol. Patients are injected at 31 locations in the frontal, corrugator and procerus muscle, the temporalis muscle, the occipitalis muscle, the cervical paraspinal muscle group and the trapezius muscles (11). The treatment is repeated every 12 weeks, performed by specially trained medical doctors or nurses.
We will measure elastography of the trapezius muscle before and 5-6 weeks after botox injection. In addition measure with QST
详细描述
Study population
The population considered for inclusion in the study is patients with CM treated with botulinum toxin A injections every third months at DHC. This is an observational study, and inclusion will not affect treatment. Patients will be included consecutively.
Inclusion criteria
Patients being treated (or are starting treatment) with botulinum toxin A injections in the clinical setting at the DHC. Treatment is based on confirmed CM-diagnosis according to the ICHD-III (4), diagnosed by headache specialists at DHC
Aged 18 - 65 years
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients being treated (or are starting treatment) with botulinum toxin A injections in the clinical setting at the DHC. Treatment is based on confirmed CM-diagnosis according to the ICHD-III (4), diagnosed by headache specialists at DHC
- •Aged 18 - 65 years
- •Able to sign an informed consent
排除标准
- •Medication overuse headache
- •Known cervical disorders, e.g. cervical spine disc prolapses, whiplash or spinal stenosis
- •Change in other pharmacological preventive medication during the study period. Stable pharmacological preventive medication is allowed.
结局指标
主要结局
Change in total tenderness score
时间窗: 6 months
Eight paired pericranial muscles and tendons are palpated in a standardized manner with a standardized pressure. small rotating movements are used while palpating. Subjects are asked to rate their tenderness on a 4-point scale (0-3). Scores from each location are added to get a total tenderness score (TTS) ranging from 0 to 48. The eight examined areas are the frontal muscle, temporal muscle, coronoid process, masseter muscle, mastoid process, sternocleidomastoid, trapezius muscle and neck muscle insertions.
Change in muscle pressure pain threshold
时间窗: 6 months
Pressure pain threshold will be assessed bilaterally over the temporalis muscle (over injection side G1), the temporalis, and index finger. The pain threshold is defined as the minimal pressure where the sensation of pressure changes to pain. The electronic pressure algometer (Somedic Algometer type 2, Sollentuna, Sweden) will be used. Three PPT measurements are measured over each area with a 30-sec interval between two consecutive measurements at the same area. Pressure will be applied at a rate of 50 kPa /second with a 1 cm2 probe.
Change in muscle stiffness
时间窗: 6 months
For measuring the muscle stiffness, we use a linear 9 MHz ultrasound probe (9L) and the Logic E9 scanner, both from GE Healthcare (Chalfont St Giles, UK). All measurements are performed with the probe parallel to the muscle fibers. We will measure the stiffness of the trapezius muscle in the middle botulinum toxin A injection side (G1) according to the PREEMPT protocol. All data are saved as images by the observer and subsequently analyzed by a blinded observer.
次要结局
未报告次要终点
研究者
Henrik Schytz
Consultant in Neurology
Danish Headache Center