HeadacheNCT06134791
Differences in Characteristics of Headache Patients With a Positive or Negative FRT: a Cross-sectional Comparison.
An observational study of Headache, run by University Ghent at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Headache
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2023to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with chronic headache, compliant to the ICHD-3 criteria for cervicogenic headache.
Who may be able to join
- Diagnosis of cervicogenic headache according to the ICHD-3 criteria:
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
University Ghent - campus UZ Ghent - Rehabilitation Sciences B3
Ghent, Oost-Vlaanderen, 9000
Dirk Cambier, Prof. dr., 093322660, dirk.cambier@ugent.be
About this study
Official title: Differences in Headache Characteristics of a Subgroup of Cervicogenic Headache Patients With a Positive or Negative FRT: a Cross-sectional Comparison.
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.
Read the 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.
- Conditions
- Headache
- Being tested
- No intervention
- Medical subject headings
- Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Cervicogenic headache with positive flexion-rotation test | Diagnosis of cervicogenic headache according to the ICHD-3 criteria. Age: 18+ years Headache for at least 1 day/week for at least 3 months Limited mobility of the neck Positive flexion-rotation test (<32 degrees on the left/right side or a difference of 10 degrees or more between left and right side) NPRS > 3/10 Receives: Other: No intervention | |
| Cervicogenic headache without positive flexion-rotation test | Diagnosis of cervicogenic headache according to the ICHD-3 criteria Age: 18+ years Headache for at least 1 day/week for at least 3 months Limited mobility of the neck Negative flexion-rotation test (>32 degrees on the left/right side or a difference of less than 10 degrees between left and right side) NPRS > 3/10 Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Headache frequency
Frequency of headache attacks will be registered
Measured: Baseline
Headache duration
Duration of headache attacks will be registered
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Secondary outcomes (8)
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).
Measured: Baseline
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.
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
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
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara Cagnie, Prof. dr., Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06134791
- Sponsor's protocol ID
- BC-10474 AM2
- Status last verified
- Nov 2023
- First submitted
- 6 Jul 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No data will be shared outside the research team.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Headache Characteristics of a Subgroup of Cervicogenic Headache Patients With a Positive or Negative FRT: a Cross-sectional Comparison.
- ClinicalTrials.gov ID
- NCT06134791
- Acronym / sponsor ID
- BC-10474 AM2
- Conditions
- Headache
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervicogenic headache with positive flexion-rotation test | – | Other: No interventionDiagnosis of cervicogenic headache according to the ICHD-3 criteria. Age: 18+ years Headache for at least 1 day/week for at least 3 months Limited mobility of the neck Positive flexion-rotation test (<32 degrees on the left/right side or a difference of 10 degrees or more between left and right side) NPRS > 3/10 |
| Cervicogenic headache without positive flexion-rotation test | – | Other: No interventionDiagnosis of cervicogenic headache according to the ICHD-3 criteria Age: 18+ years Headache for at least 1 day/week for at least 3 months Limited mobility of the neck Negative flexion-rotation test (>32 degrees on the left/right side or a difference of less than 10 degrees between left and right side) NPRS > 3/10 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic headache, compliant to the ICHD-3 criteria for cervicogenic headache.
Key inclusion criteria (8 listed)
- Diagnosis of cervicogenic headache according to the ICHD-3 criteria:
- 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
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Cervicogenic headache with positive flexion-rotation test, Cervicogenic headache without positive flexion-rotation test |
Primary outcome
Headache pain intensity
Time frame: 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 frequency
Time frame: Baseline
Frequency of headache attacks will be registered
Headache duration
Time frame: Baseline
Duration of headache attacks will be registered
Headache related disability
Time frame: 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
Time frame: 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.
Neck pain intensity
Time frame: 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
Time frame: 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.
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. No data will be shared outside the research team.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Cagnie, Prof. dr. principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Cagnie, Prof. dr. (+32 9 332 52 6, Barbara.Cagnie@Ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache pain intensity (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.