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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04242290
Other study ID # 19-KAEK-064
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2019
Est. completion date September 20, 2019

Study information

Verified date January 2020
Source Hitit University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date September 20, 2019
Est. primary completion date July 20, 2019
Accepts healthy volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
Lateral radiography
The lordosis angles were measured on the lateral cervical graphs of all patients.

Locations

Country Name City State
Turkey Hitit University Erol Olcok Training and Research Hospital Çorum

Sponsors (1)

Lead Sponsor Collaborator
Hitit University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Peñas 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. — View Citation

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. — View Citation

Knackstedt H, Kråkenes 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Neck disability index The NDI is the most widely used questionnaire to investigate the disability associated with neck pain. 3 months
Other Visual analog scale The VAS pain scale is used to measure and monitor pain severity. 3 months
Primary 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 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" 3 months
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