Clinical trial NCT06134791: Differences in Characteristics of Headache Patients With a Positive or Negative FRT: a Cross-sectional Comparison.
Official title: Differences in Headache Characteristics of a Subgroup of Cervicogenic Headache Patients With a Positive or Negative FRT: a Cross-sectional Comparison.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Headache
Lead sponsor: University Ghent
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with chronic headache, compliant to the ICHD-3 criteria for cervicogenic headache.

Brief summary: 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.

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

Primary outcomes:
measure: Headache pain intensity
timeFrame: Baseline
measure: Headache frequency
timeFrame: Baseline
measure: Headache duration
timeFrame: Baseline
measure: Headache related disability
timeFrame: Baseline
measure: Headache related impact
timeFrame: Baseline
measure: Neck pain intensity
timeFrame: Baseline
measure: Neck disability
timeFrame: Baseline
Secondary outcomes:
measure: Pain Pressure Thresholds (PPTs)
timeFrame: Baseline
measure: Joint Position Error
timeFrame: Baseline
measure: Global active range of motion of the cervical spine.
timeFrame: Baseline
measure: Motor control of the cervical spine (craniocervical flexion test)
timeFrame: Baseline
measure: Psychosocial headache related parameters: central sensitization by using the Central Sensitization Index (CSI).
timeFrame: Baseline
measure: Psychosocial headache related parameters: pain catastrophizing as measured by the Pain Catastrophizing Scale (PCS)
timeFrame: Baseline
measure: Psychosocial headache related parameters: pain coping as measured by the Pain Coping Inventory(PCI).
timeFrame: Baseline
measure: Psychosocial headache related parameters: pain related fear as measured by the Tampa Scale of Kinesiophobia (TSK).
timeFrame: Baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Ghent - campus UZ Ghent - Rehabilitation Sciences B3
state: Oost-Vlaanderen
Study officials:
affiliation: University Ghent
name: Barbara Cagnie, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: