We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

Cervicospinal Posture and Pain in Cervicogenic Headache

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04242290
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Information provided by (Responsible Party):
Yeliz Bahar Ozdemir, Hitit University

Brief 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 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.

Condition or disease Intervention/treatment
Cervicogenic Headache Neck Pain Diagnostic Test: Lateral radiography

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 6 Months
Official Title: Is it Possible to Distinguish Cervicogenic Headache From Neck Pain With Cervicospinal Posture?: A Single-blind, Prospective Cross-sectional Trial
Actual Study Start Date : March 20, 2019
Actual Primary Completion Date : July 20, 2019
Actual Study Completion Date : September 20, 2019

Group/Cohort Intervention/treatment
Cervicogenic headache
The group with cervicogenic headaches
Diagnostic Test: Lateral radiography
The lordosis angles were measured on the lateral cervical graphs of all patients.

Neck pain
The group with isolated neck pain
Diagnostic Test: Lateral radiography
The lordosis angles were measured on the lateral cervical graphs of all patients.

Primary Outcome Measures :
  1. 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".

Secondary Outcome Measures :
  1. 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"

Other Outcome Measures:
  1. Neck disability index [ Time Frame: 3 months ]
    The NDI is the most widely used questionnaire to investigate the disability associated with neck pain.

  2. Visual analog scale [ Time Frame: 3 months ]
    The VAS pain scale is used to measure and monitor pain severity.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Probability Sample
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04242290

Layout table for location information
Hitit University Erol Olcok Training and Research Hospital
Çorum, Turkey, 19000
Sponsors and Collaborators
Hitit University
Layout table for investigator information
Principal Investigator: Yeliz Bahar Ozdemir Hitit University Erol Olcok Training and Research Hospital
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Yeliz Bahar Ozdemir, Medical Doctor, Hitit University
ClinicalTrials.gov Identifier: NCT04242290    
Other Study ID Numbers: 19-KAEK-064
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yeliz Bahar Ozdemir, Hitit University:
Cervicogenic headache
Additional relevant MeSH terms:
Layout table for MeSH terms
Post-Traumatic Headache
Neck Pain
Neurologic Manifestations
Headache Disorders, Secondary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases