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

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.

Study Overview

• Status: Completed
• Conditions: Headache Disorders
• Intervention / Treatment: Other: inflammation

Detailed Description

Study design This prospective study was completed at an emergency care of a tertiary referral hospital between May 2018 and May 2019. The hospital admits a total of 45.000 adult emergency patients per year. This study was approved by the local ethics Committee of Kocaeli University (KOU/KAE: 2018/192) in accordance with the Helsinki Declaration. Written and informed consent form was obtained from all individual participants.

Study population Investigators screened 720 patients who admitted to the ED with an acute headache attack. Clinical evaluation was performed by an experienced neurologist. Consequently, 51 patients with MA, 51 patients with MO, and 48 patients with TTH according to the diagnostic criterias of ICHD-3 and 80 age- and gender matched healthy controls were enrolled in this study. Detailed sociodemographic and clinical data collected using face-to-face interview. Visual analog scale (VAS) documented to measure the intensity of pain in patient groups.

Investigators included adult participants aged between 18 and 65 years. Also, subjects were eligible for inclusion if their body mass index (BMI) ranges were between18 kg/m2 and 30 kg/m2. Patients with secondary headaches, trauma, malignancy, chronic inflammatory disorders, infectious diseases, hematologic abnormalities, a prior history of surgery (within the preceding 6 months), receiving analgesics, antibiotics, blood transfusion and other blood products, were excluded from the study.

Laboratory analysis Complete blood count (CBC) parameters [WBC, neutrophil, lymphocyte, platelet] of patients and control groups were obtained from 2 cc peripheral venous blood samples (purple K3 EDTA tubes, Beckman Coulter DXH 800 Analyzer) during admission. NLR and PLR were calculated by dividing absolute neutrophil to absolute lymphocyte count and absolute platelet to absolute lymphocyte count, respectively.

Statistical Analysis SPSS 17.0 statistical software package program (IBM Corporation, USA) was used for the analysis. Descriptive data were presented using numbers, percentages (%) , mean ± standard deviation. Categorical variables were analyzed by using chi-square (χ2) test. Normality tests (Shapiro-Wilks, Lilliefors, and Kolmogorov-Smirnov) were used for all parameters. Due to the non-normal distribution of CBC values, Kruskal-Wallis and Tamhane's T2 post hoc tests were used to compare between patients with MA, MO, TTH, and healthy controls. A p value ≤ 0.05 considered statistically significant.

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Turkey
  • İzmit
    • Kocaeli, İzmit, Turkey, 41100
      • Halil Okay Albayrak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Migraine and tension-type headache patients who admitted to emergency department with an acute headache attack

Description

Inclusion Criteria;

• 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

Exclusion Criteria;

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
migraine with aura; 51 patients with MA	Other: inflammation; inflammatory values in complete blood count (CBC)
migraine without aura; 51 patients with migraine without aura	Other: inflammation; inflammatory values in complete blood count (CBC)
tension type headache; 48 patients with tension type headache	Other: inflammation; inflammatory values in complete blood count (CBC)
healthy controls; 80 healthy participants	Other: inflammation; inflammatory values in complete blood count (CBC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kocaeli University
• Investigators: Study Chair: Serkan Yılmaz, Prof, Kocaeli University Department of Emergency Medicine; Study Director: Serkan Yılmaz, Prof, Kocaeli University Department of Emergency Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: inflammation; primary headache; neuroinflammation; migraine with aura; migraine without aura; tension type headache
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Inflammation; Headache; Tension-Type Headache; Headache Disorders
• Other Study ID Numbers: KOU/KAE: 2018/192

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No