Assessment of Inflammation in Primary Headaches
Assessment of Inflammation With Haematological Parameters in Patients With Migraine and Tension Type Headache: a Prospective Study From a Tertiary Care Center
1 other identifier
observational
230
1 country
1
Brief Summary
Headache is the most common neurological complaint accounting for % 1 to % 4 in the emergency department (ED).Every year, nearly one million people with headache attacks have been consulted by healthcare professionals at the emergency room in the United States.The International Classification of Headache Disorders (ICHD) divided headaches into two main groups: primary headaches and secondary headaches. The vast majority of cases who presented with acute headache attack in ED had a diagnosis of primary headache disorders (tension- type headache, migraine, cluster- type headache, and other primary headaches). However, secondary headache is often associated with underlying intracranial pathologies, and noted in % 10 of cases in emergency rooms. Despite the frequent presence of primary headaches, limited time setting and busy periods of medical assessment, leading diagnostic and therapeutic options due to the pathophysiological factors to be overlooked. To date, no study in the emergency care setting has explored the role of inflammation in patients with acute migraine and TTH. Investigators aimed to explore inflammatory markers \[white blood cells (WBC), neutrophil, lymphocyte, platelet, neutrophil / lymphocyte ratio (NLR), and platelet / lymphocyte ratio (PLR)\] in complete blood count (CBC) among MA, MO, and TTH participants who admitted to ED with acute headache attack and healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2019
CompletedFirst Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 19, 2021
CompletedMay 19, 2021
May 1, 2021
1.1 years
April 20, 2021
May 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
White blood cells
White blood cells (x10³/μL) counted in complete blood count and compared between patients and healthy controls
Up to 1 year
Neutrophil
Neutrophil (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Up to 1 year
Lymphocyte
Lymphocyte (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Up to 1 year
Platelet
Platelet (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Up to 1 year
Neutrophil/lymphocyte ratio
Neutrophil/lymphocyte ratio calculated by dividing absolute neutrophil to absolute lymphocyte and compared between patients and healthy controls.
Up to 1 year
Platelet/lymphocyte ratio
Platelet/lymphocyte ratio calculated by dividing absolute platelet to absolute lymphocyte and compared between patients and healthy controls.
Up to 1 year
Study Arms (4)
migraine with aura
51 patients with MA
migraine without aura
51 patients with migraine without aura
tension type headache
48 patients with tension type headache
healthy controls
80 healthy participants
Interventions
inflammatory values in complete blood count (CBC)
Eligibility Criteria
Migraine and tension-type headache patients who admitted to emergency department with an acute headache attack
You may qualify if:
- Clinical diagnosis of Migraine
- Clinical diagnosis of Tension- type headache
- Age between 18 and 65 years
- Body mass index between 18 kg/m2 and 30 kg/m2
You may not qualify if:
- Secondary headaches
- Chronic inflammatory disorders
- Infectious diseases
- Hematologic abnormalities
- A prior history of surgery (within the preceding 6 months)
- Receiving analgesics
- Blood transfusion before admission
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Halil Okay Albayrak
Kocaeli, İzmit, 41100, Turkey (Türkiye)
Related Publications (1)
Albayrak HO, Gurbuz H, Basaran S, Yilmaz S. Assessment of inflammation with hematological parameters in patients with migraine and tension-type headache: a prospective study from a tertiary care center. Pain Manag. 2022 Mar;12(2):141-148. doi: 10.2217/pmt-2021-0036. Epub 2021 Aug 25.
PMID: 34431322DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Serkan Yılmaz, Prof
Kocaeli University Department of Emergency Medicine
- STUDY DIRECTOR
Serkan Yılmaz, Prof
Kocaeli University Department of Emergency Medicine
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator, Department of Emergency Medicine
Study Record Dates
First Submitted
April 20, 2021
First Posted
May 19, 2021
Study Start
May 1, 2018
Primary Completion
May 31, 2019
Study Completion
May 31, 2019
Last Updated
May 19, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share