Cervicogenic HeadacheNCT04242290
Cervicospinal Posture and Pain in Cervicogenic Headache
An observational study of Cervicogenic Headache and Neck Pain, run by Hitit University at 1 site in Turkey (Türkiye).
Trial summary
Cervicogenic headache (CEH) is a type of symptomatic headache that is characterized by chronic unilateral headache secondary to cervical spine dysfunction. Generally, it gets worse by neck movements, continuous placement of the head in an awkward position and exposure to external pressure on the upper cervical or… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cervicogenic Headache, Neck Pain
- What is being tested?
- Lateral radiography
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Mar 2019to 20 Sep 2019
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 50 years
- Women only
- Adult
Study population: It was included 45 women with cervicogenic headaches with an age of 18-50 years and 45 women with only neck pain in the same ages who presented to the Neurosurgery outpatient clinic.
Who may be able to join
- For Cervicogenic headache group
- Unilateral headache, starting from the upper neck/occipital region and spreading to the oculofrontotemporal area on the symptomatic side
- Pain triggered by neck movements and/or continuous awkward positions
- Decreased joint range of motion in the cervical vertebra
Who cannot join
- For Cervicogenic headache group
- Previously diagnosed to have any other syndromes of headache (Migraine, Tension headache, etc.)
- Presence of bilateral headache; For the neck pain group,
- Presence of 2 or more neurological symptoms (decreased upper extremity muscle strength, decreased reflexes and hypoesthesia compatible with the dermatome regions)
- Suggesting nerve root compression (radiculopathy, plexopathy); for both groups,
- Presence of any signs suspicious of central nervous system involvement (hyperreflexia, nystagmus, decreased vision, etc)
- Reluctance to participate in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hitit University Erol Olcok Training and Research Hospital
Çorum, 19000
About this study
Official title: Is it Possible to Distinguish Cervicogenic Headache From Neck Pain With Cervicospinal Posture?: A Single-blind, Prospective Cross-sectional Trial
Cervicogenic headache (CEH) is a type of symptomatic headache that is characterized by chronic unilateral headache secondary to cervical spine dysfunction. Generally, it gets worse by neck movements, continuous placement of the head in an awkward position and exposure to external pressure on the upper cervical or occipital region.
The pain was demonstrated to originate from lower cervical disc prolapse and spinal nerve roots in some studies, while it is suggested in some others to occur due to the upper cervical region as well. Although disturbed cervical alignment has been determined in tension headache and migraine, there are few studies with controversial results in the literature investigating the effects of the change in cervical lordosis on CEH. These contradictory results strongly influence the decision of whether exercise should be added to the treatment protocol in CEH and also the creation of an appropriate treatment program by the clinicians. In light of this background, the aim of this study was to compare the cervical radiographs of patients with CEH and patients with neck pain without a headache.
Read the detailed description
The general demographics, pain status and cervical radiological evaluations of the patients was performed in this prospective, cross-sectional, single-blind study evaluating two different disease groups compatible in age and gender and the two groups were compared.
For inclusion in the Cervicogenic Headache group, inclusion criteria determined by the Cervicogenic Headache International Study Group (CHISG) were used.
Symptoms of all patients were questioned in detail and physical examinations were performed. After obtaining demographic information such as age, height and weight, severity and duration of pain were asked to the patients and Neck Disability Index (NDI) and Visual Analogue Scale (VAS) were used for pain assessment Cervical radiographic analysis was evaluated measuring general cervical lordosis and upper cervical lordosis on lateral standing X-rays using Surgimap®. General cervical lordosis and Upper cervical lordosis measurements were performed on the lateral cervical graph.
- Conditions
- Cervicogenic Headache, Neck Pain
- Being tested
- Lateral radiography
- Keywords
- Cervicogenic headache, Disability, Pain
- Medical subject headings
- Post-Traumatic Headache, Neck Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral radiographyDiagnostic test
The lordosis angles were measured on the lateral cervical graphs of all patients.
| Study group | Role | What they receive |
|---|---|---|
| Cervicogenic headache | The group with cervicogenic headaches Receives: Diagnostic Test: Lateral radiography | |
| Neck pain | The group with isolated neck pain Receives: Diagnostic Test: Lateral radiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
General cervical lordosis
General cervical lordosis is basically measured by the "Cobb" method. In the lateral graph, the angle between the two lines drawn perpendicular to the lines passing on the inferior end plate of the C2 and C7 vertebrae is considered as the "General cervical lordosis angle".
Measured: 3 months
Secondary outcomes (1)
Upper cervical lordosis
For the measurement of upper cervical lordosis, a line is drawn from the uppermost posterior point of the odontoid process to the lowermost posterior point of C2. The second line is drawn to pass between the lowermost-posterior portions of the C3 and C4 cervical vertebrae. The angle between these two lines is considered the "upper cervical lordosis angle"
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start20 Mar 2019
- Primary completion20 Jul 2019
- Study completion20 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Hitit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Bahar Ozdemir, Hitit University
- Investigators
- Yeliz Bahar Ozdemir, Principal investigator, Hitit University Erol Olcok Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242290
- Sponsor's protocol ID
- 19-KAEK-064
- Status last verified
- Jan 2020
- First submitted
- 22 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
PubMed 26852024Farmer PK, Snodgrass SJ, Buxton AJ, Rivett DA. An investigation of cervical spinal posture in cervicogenic headache. Phys Ther. 2015 Feb;95(2):212-22. doi: 10.2522/ptj.20140073. Epub 2014 Oct 9.
PubMed 25301967Knackstedt H, Krakenes J, Bansevicius D, Russell MB. Magnetic resonance imaging of craniovertebral structures: clinical significance in cervicogenic headaches. J Headache Pain. 2012 Jan;13(1):39-44. doi: 10.1007/s10194-011-0387-4. Epub 2011 Sep 27.
PubMed 21947945
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Possible to Distinguish Cervicogenic Headache From Neck Pain With Cervicospinal Posture?: A Single-blind, Prospective Cross-sectional Trial
- ClinicalTrials.gov ID
- NCT04242290
- Acronym / sponsor ID
- 19-KAEK-064
- Conditions
- Cervicogenic Headache, Neck Pain
- Keywords
- Cervicogenic headache, Disability, Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hitit UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Jul 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 27 Jan 2020 (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.
Cervicogenic headache (CEH) is a type of symptomatic headache that is characterized by chronic unilateral headache secondary to cervical spine dysfunction. Generally, it gets worse by neck movements, continuous placement of the head in an awkward position and exposure to external pressure on the upper cervical or occipital region.
The pain was demonstrated to originate from lower cervical disc prolapse and spinal nerve roots in some studies, while it is suggested in some others to occur due to the upper cervical region as well. Although disturbed cervical alignment has been determined in tension headache and migraine, there are few studies with controversial results in the literature investigating the effects of the change in cervical lordosis on CEH. These contradictory results strongly influence the decision of whether exercise should be added to the treatment protocol in CEH and also the creation of an appropriate treatment program by the clinicians. In light of this background, the aim of this study was to compare the cervical radiographs of patients with CEH and patients with neck pain without a headache.
Detailed description
The general demographics, pain status and cervical radiological evaluations of the patients was performed in this prospective, cross-sectional, single-blind study evaluating two different disease groups compatible in age and gender and the two groups were compared.
For inclusion in the Cervicogenic Headache group, inclusion criteria determined by the Cervicogenic Headache International Study Group (CHISG) were used.
Symptoms of all patients were questioned in detail and physical examinations were performed. After obtaining demographic information such as age, height and weight, severity and duration of pain were asked to the patients and Neck Disability Index (NDI) and Visual Analogue Scale (VAS) were used for pain assessment Cervical radiographic analysis was evaluated measuring general cervical lordosis and upper cervical lordosis on lateral standing X-rays using Surgimap®. General cervical lordosis and Upper cervical lordosis measurements were performed on the lateral cervical graph.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cervicogenic headache | – | Diagnostic Test: Lateral radiographyThe group with cervicogenic headaches |
| Neck pain | – | Diagnostic Test: Lateral radiographyThe group with isolated neck pain |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- It was included 45 women with cervicogenic headaches with an age of 18-50 years and 45 women with only neck pain in the same ages who presented to the Neurosurgery outpatient clinic.
Key inclusion criteria (4 listed)
- For Cervicogenic headache group
- Unilateral headache, starting from the upper neck/occipital region and spreading to the oculofrontotemporal area on the symptomatic side
- Pain triggered by neck movements and/or continuous awkward positions
- Decreased joint range of motion in the cervical vertebra
Key exclusion criteria (7 listed)
- For Cervicogenic headache group
- Previously diagnosed to have any other syndromes of headache (Migraine, Tension headache, etc.)
- Presence of bilateral headache; For the neck pain group,
- Presence of 2 or more neurological symptoms (decreased upper extremity muscle strength, decreased reflexes and hypoesthesia compatible with the dermatome regions)
- Suggesting nerve root compression (radiculopathy, plexopathy); for both groups,
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 |
|---|---|---|
| Lateral radiographyThe lordosis angles were measured on the lateral cervical graphs of all patients. | Diagnostic test | Cervicogenic headache, Neck pain |
Primary outcome
General cervical lordosis
Time frame: 3 months
General cervical lordosis is basically measured by the "Cobb" method. In the lateral graph, the angle between the two lines drawn perpendicular to the lines passing on the inferior end plate of the C2 and C7 vertebrae is considered as the "General cervical lordosis angle".
1 secondary outcome
Upper cervical lordosis
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Background: PubMed 26852024Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.
- Background: PubMed 25301967Farmer PK, Snodgrass SJ, Buxton AJ, Rivett DA. An investigation of cervical spinal posture in cervicogenic headache. Phys Ther. 2015 Feb;95(2):212-22. doi: 10.2522/ptj.20140073. Epub 2014 Oct 9.
- Results publication: PubMed 21947945Knackstedt H, Krakenes J, Bansevicius D, Russell MB. Magnetic resonance imaging of craniovertebral structures: clinical significance in cervicogenic headaches. J Headache Pain. 2012 Jan;13(1):39-44. doi: 10.1007/s10194-011-0387-4. Epub 2011 Sep 27.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Yeliz Bahar Ozdemir principal investigator
Hitit University Erol Olcok Training and Research Hospital
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 Cervicogenic Headache and Neck Pain, run by Hitit University at 1 site in Turkey (Türkiye).
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 4 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: finished, as of the sponsor's last update on 27 Jan 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General cervical lordosis (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04242290, which also lists 3 linked publications.
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 27 Jan 2020.