NCT04242290

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

January 22, 2020

Last Update Submit

January 22, 2020

Conditions

Keywords

Cervicogenic headacheDisabilityPain

Outcome Measures

Primary Outcomes (1)

  • 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".

    3 months

Secondary Outcomes (1)

  • Upper cervical lordosis

    3 months

Other Outcomes (2)

  • Neck disability index

    3 months

  • Visual analog scale

    3 months

Study Arms (2)

Cervicogenic headache

The group with cervicogenic headaches

Diagnostic Test: Lateral radiography

Neck pain

The group with isolated neck pain

Diagnostic Test: Lateral radiography

Interventions

Lateral radiographyDIAGNOSTIC_TEST

The lordosis angles were measured on the lateral cervical graphs of all patients.

Cervicogenic headacheNeck pain

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hitit University Erol Olcok Training and Research Hospital

Çorum, 19000, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 26852024BACKGROUND
  • 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.

    PMID: 25301967BACKGROUND
  • 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.

MeSH Terms

Conditions

Post-Traumatic HeadacheNeck PainPain

Condition Hierarchy (Ancestors)

Headache Disorders, SecondaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yeliz Bahar Ozdemir

    Hitit University Erol Olcok Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

January 22, 2020

First Posted

January 27, 2020

Study Start

March 20, 2019

Primary Completion

July 20, 2019

Study Completion

September 20, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations