Headache Clinical Trial
Official title:
Differences in Headache Characteristics of a Subgroup of Cervicogenic Headache Patients With a Positive or Negative FRT: a Cross-sectional Comparison.
NCT number | NCT06134791 |
Other study ID # | BC-10474 AM2 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | December 2026 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Ghent - campus UZ Ghent - Rehabilitation Sciences B3 | Ghent | Oost-Vlaanderen |
Lead Sponsor | Collaborator |
---|---|
University Ghent |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Headache pain intensity | 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. | Baseline | |
Primary | Headache frequency | Frequency of headache attacks will be registered | Baseline | |
Primary | Headache duration | Duration of headache attacks will be registered | Baseline | |
Primary | Headache related disability | 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. | Baseline | |
Primary | Headache related impact | 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. | Baseline | |
Primary | Neck pain intensity | 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. | Baseline | |
Primary | Neck disability | 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. | Baseline | |
Secondary | Pain Pressure Thresholds (PPTs) | PPT measurements will be registered with the digital hand-held pressure algometer (Wagner FPX 25 Force Gage).
To standardize the pressure applied by the investigator, the same investigator always stabilized his wrist with his other hand. The PPT assessment was performed two times with a 30-second break between each application and the pressure will be increased by 1N/s until the patient reports the pressure as unpleasant. This pressure will be taken as PPT expressed in Newton (N); and the average will be taken of the three measurements on the spinous process of C2 and the Upper Trapezius Muscle (bilateral measurement). |
Baseline | |
Secondary | Joint Position Error | Joint position error will be registered with the digital Motion Guidance Laser.
The Cervical Joint Position Error (JPE) Test is a measurement tool used to clinically assess an individual's cervicocephalic proprioception ability. Cervicocephalic proprioception describes one's sense of position of their head and neck in space. The Cervical JPE Test measures the ability of a blindfolded patient to accurately relocate their head position back to a predetermined neutral point after cervical joint movement. The average of 6 measurements to each side will be used to determine JPE. |
Baseline | |
Secondary | Global active range of motion of the cervical spine. | Changes in global cervical mobility will be assessed at baseline. Measurements will be registered with the digital EasyAngle Goniometer (Meloq). | Baseline | |
Secondary | Motor control of the cervical spine (craniocervical flexion test) | The Craniocervical flexion test (CCFT) is a clinical test of neuromotor control including the activation and endurance of the deep flexors of the cervical spine. This test involves the subject performing a "yes" like nod which is the anatomical action of the Deep Cervical flexors, against a pressure biofeedback.
Two subscores will be used: for performance and for endurance of the deep cervical flexors. |
Baseline | |
Secondary | Psychosocial headache related parameters: central sensitization by using the Central Sensitization Index (CSI). | The Central Sensitization Index (CSI) score ranges from 0 to 100, allowing to make the following classifications of sensitization:
0-29 Subclinical 30-39 Mild 40-49 Moderate 50-59 Severe 60-100 Extreme |
Baseline | |
Secondary | Psychosocial headache related parameters: pain catastrophizing as measured by the Pain Catastrophizing Scale (PCS) | The Pain Catastrophizing Scale (PCS) has 13 items, each belonging to one of three of the following subscales:
Rumination (item 8,9,10,11) Magnification (item 6,7,13) Helplessness (item 1,2,3,4,5,12) The total score of the questionnaire ranges from 0 to 52. The higher the score, the more pain catastrophizing the patient shows. |
Baseline | |
Secondary | Psychosocial headache related parameters: pain coping as measured by the Pain Coping Inventory(PCI). | The Pain Coping Inventory (PCI) records which coping strategy is preferred by the patient. The inventory contains 6 scales which can be divided in active coping strategies (Pain Transformation, Distraction, Reducing Demands) or passive coping strategies (Retreating, Worrying, Resting).
The higher the score per domain, the more the patients uses that type of coping. |
Baseline | |
Secondary | Psychosocial headache related parameters: pain related fear as measured by the Tampa Scale of Kinesiophobia (TSK). | The Tampa Scale of Kinesiophobia (TSK) contains 17 items and the total score can range from 17 to 68.
A score of more than 37 points towards kinesiophobia. |
Baseline |
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