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Recruiting NCT06134791

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

Observational Headache

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Headache. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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.

Participants will be subjected to a single assessment, which involves questionnaires and measurements of the cervical spine.

Interventions

  • Other No intervention
    No intervention

Primary outcome measures

  • Headache pain intensity [Time frame: Baseline]
  • Headache frequency [Time frame: Baseline]
  • Headache duration [Time frame: Baseline]
  • Headache related disability [Time frame: Baseline]
  • Headache related impact [Time frame: Baseline]
  • Neck pain intensity [Time frame: Baseline]
  • Neck disability [Time frame: Baseline]
Secondary outcome measures (8)
  • Pain Pressure Thresholds (PPTs) [Time frame: Baseline]
  • Joint Position Error [Time frame: Baseline]
  • Global active range of motion of the cervical spine. [Time frame: Baseline]
  • Motor control of the cervical spine (craniocervical flexion test) [Time frame: Baseline]
  • Psychosocial headache related parameters: central sensitization by using the Central Sensitization Index (CSI). [Time frame: Baseline]
  • Psychosocial headache related parameters: pain catastrophizing as measured by the Pain Catastrophizing Scale (PCS) [Time frame: Baseline]
  • Psychosocial headache related parameters: pain coping as measured by the Pain Coping Inventory(PCI). [Time frame: Baseline]
  • Psychosocial headache related parameters: pain related fear as measured by the Tampa Scale of Kinesiophobia (TSK). [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Belgium · 1 center
  • University Ghent - campus UZ Ghent - Rehabilitation Sciences B3 — Ghent

Identifiers

NCT: NCT06134791 · BC-10474 AM2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗