跳至主要内容
临床试验/NCT06134791
NCT06134791招募中不适用

Differences in Headache Characteristics of a Subgroup of Cervicogenic Headache Patients With a Positive or Negative FRT: a Cross-sectional Comparison.

University Ghent1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Headache frequency

研究概览

简要总结

An observational study will be conducted to evaluate the differences in headache characteristics between a subgroup of cervicogenic headache patients with a positive and negative flexion-rotation test at the C1-C2 level. Differences may guide future treatment allocation and the use of more individualized treatment options.

详细描述

Headache is a common and disabling condition. Several primary and secondary headache forms have been described, such as migraine, tension-type headache and cervicogenic headache (CH). In patients with CH; we can see a referred pain pattern to the head, possibly originating from a source in the (upper)cervical spine. It has been described that nociceptive input, originating from the C1-C3 nervous system may be responsible for pain referral to head and neck regions. Recently, the flexion-rotation test (FRT) has been described as one of the most useful clinical tests in the clinical testing and research of CH. Other literature showed that the rotational movement during the FRT was diminished in patients with CH and these results were correlated to headache intensity.

To treat this disabling condition, manual therapy is already known to be an effective treatment strategy. However, the additional value of dry needling is still to be discussed. Since the M. Obliquus capitis inferior (M. OCI) finds its origin on the apex of the spinous processus of C2 and inserts on transverse processus of the atlas (C1); this muscle might be anatomically very relevant to influence rotational mobility in the upper cervical spine. Additionally, this muscle is responsible for proprioception and accurate positioning of the head and neck, due to the presence of a large amount of Golgi bodies and muscle spindles in the muscle. Considering the myofascial pain referral pattern of the M. OCI, a referred pain pattern to the temporal region may be present when active triggerpoints are present.

Previous research already showed some preliminary evidence for positive treatment effects by dry needling of the M. OCI in patients with cervicogenic dizziness and headache.

The goal of this study is to evaluate the differences in headache characteristics between a subgroup of cervicogenic headache patients with a positive and negative flexion-rotation test at the C1C2 level. Differences may guide future treatment allocation and the use of more individualized treatment options.

In this observational study, 100 patients with cervicogenic headache will be recruited. Participants are required to have complaints for at least 3 months. Participants are included based on online questionnaires and a clinical examination of the neck and shoulder region. All participants will receive information and have to sign an informed consent form.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of cervicogenic headache according to the ICHD-3 criteria:
  • A. Any headache fulfilling criterion C B. Clinical and/or imaging evidence1 of a disorder or lesion within the cervical spine or soft tissues of the neck, known to be able to cause headache2
  • C. Evidence of causation demonstrated by at least two of the following:
  • headache has developed in temporal relation to the onset of the cervical disorder or appearance of the lesion
  • headache has significantly improved or resolved in parallel with improvement in or resolution of the cervical disorder or lesion
  • cervical range of motion is reduced, and headache is made significantly worse by provocative manœuvres
  • headache is abolished following diagnostic blockade of a cervical structure or its nerve supply D. Not better accounted for by another ICHD-3 diagnosis
  • Age: 18+ years Headache for at least 1 day/week for at least 3 months Limited mobility of the neck NPRS > 3/10

排除标准

  • Primary headache forms: migraine, TTH
  • Other secondary headaches that do not comply with the ICDH-3 criteria for CH
  • Whiplash or other traumatic incident in the past
  • Pregnancy or given birth in the last year
  • Previous head, neck or shoulder surgery
  • Cervical radiculopathy complaints
  • Receiving other treatments for headache or neck pain (physical therapy/ostheopathy/chiropraxie...) in the previous month

结局指标

主要结局

Headache frequency

时间窗: Baseline

Frequency of headache attacks will be registered

Headache duration

时间窗: Baseline

Duration of headache attacks will be registered

Neck pain intensity

时间窗: Baseline

Subjects will have to report their actual pain complaints on a numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst pain) at baseline testing.

Neck disability

时间窗: Baseline

Neck pain related disability will be questioned using the NDI (Neck Disability Index). The total score ranges from 0 to 50, with a higher score indicating more disability.

Headache pain intensity

时间窗: Baseline

Subjects will have to report their actual pain complaints on a numeric pain rating scale (NPRS) ranging from 0 (no pain) to 10 (worst pain) at baseline testing.

Headache related disability

时间窗: Baseline

Headache related disability will be questioned using the Henry Ford Headache Disability Index (HDI). The total score ranges from 0-100. The higher the score, the more disabilitating the headache is for the patient.

Headache related impact

时间窗: Baseline

Headache related disability will be questioned using the Headache Impact Test (HIT-6) questionnaire. The total score can range from 36 to 78, with a higher score indicating the headache has more impact on daily life.

次要结局

  • Pain Pressure Thresholds (PPTs)(Baseline)
  • Psychosocial headache related parameters: central sensitization by using the Central Sensitization Index (CSI).(Baseline)
  • Global active range of motion of the cervical spine.(Baseline)
  • Psychosocial headache related parameters: pain catastrophizing as measured by the Pain Catastrophizing Scale (PCS)(Baseline)
  • Joint Position Error(Baseline)
  • Psychosocial headache related parameters: pain related fear as measured by the Tampa Scale of Kinesiophobia (TSK).(Baseline)
  • Motor control of the cervical spine (craniocervical flexion test)(Baseline)
  • Psychosocial headache related parameters: pain coping as measured by the Pain Coping Inventory(PCI).(Baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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