- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04242290
Cervicospinal Posture and Pain in Cervicogenic Headache
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Çorum, Turkey, 19000
- Hitit University Erol Olcok Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
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
Exclusion Criteria:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cervicogenic headache
The group with cervicogenic headaches
|
The lordosis angles were measured on the lateral cervical graphs of all patients.
|
Neck pain
The group with isolated neck pain
|
The lordosis angles were measured on the lateral cervical graphs of all patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Upper cervical lordosis
Time Frame: 3 months
|
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"
|
3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck disability index
Time Frame: 3 months
|
The NDI is the most widely used questionnaire to investigate the disability associated with neck pain.
|
3 months
|
Visual analog scale
Time Frame: 3 months
|
The VAS pain scale is used to measure and monitor pain severity.
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Farmer 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.
- Knackstedt 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-KAEK-064
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neck Pain
-
Fatih TekinPamukkale UniversityCompletedChronic Neck Pain | Persistent Neck Pain | Neuroscience ApproachTurkey
-
Jeff Elias, MDRecruitingCancer of Head and Neck | Pain, Neck | Pain, FaceUnited States
-
Hacettepe UniversityRecruitingNeck Pain | Cervical Pain | Neck Pain, Posterior | Neck Muscle Issue | Cervical Pain, PosteriorTurkey
-
Riphah International UniversityCompletedCervical Pain | Mechanical Neck PainPakistan
-
Riphah International UniversityCompleted
-
Instituto Brasileiro de OsteopatiaCompletedNeck Pain | Pain, NeckBrazil
-
Ankara UniversityCompleted
-
Josue Fernandez CarneroCentro Universitario La SalleCompleted
-
Sakarya UniversityUnknown
-
Shanghai University of Traditional Chinese MedicineBeijing Hospital; Dongzhimen Hospital, Beijing; Traditional Chinese Medicine... and other collaboratorsNot yet recruiting
Clinical Trials on Lateral radiography
-
Damascus UniversityCompletedImpacted CaninesSyrian Arab Republic
-
Centre Hospitalier Régional d'OrléansCompleted
-
Ramsay Générale de SantéEuropean Clinical Trial Experts Network; Private Hospital Jean MermozRecruitingKnee Injuries | ACL | ALL | Anterior Curciate Ligament | Anterolateral LigamentFrance
-
Centre Hospitalier Universitaire DijonUnknown
-
Balgrist University HospitalCompletedCongenital Medial DeviationSwitzerland
-
Nanfang Hospital, Southern Medical UniversityRecruiting
-
Centre Hospitalier Universitaire DijonTerminatedInsertion of a Nasogastric Tube | Intubated Patient | Patients Hospitalized in the Surgery Intensive Care UnitFrance
-
University Hospital, GrenobleCompleted
-
Shiraz University of Medical SciencesUnknownRoot CanalIran, Islamic Republic of
-
Bakirkoy Dr. Sadi Konuk Research and Training HospitalNot yet recruitingScoliosis | Kyphosis | Radiography