Clinical trial NCT04891848: Assessment of Inflammation in Primary Headaches
Official title: Assessment of Inflammation With Haematological Parameters in Patients With Migraine and Tension Type Headache: a Prospective Study From a Tertiary Care Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Headache Disorders
Keywords: primary headache
migraine with aura
migraine without aura
tension type headache
inflammation
neuroinflammation
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migraine and tension-type headache patients who admitted to emergency department with an acute headache attack

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: White blood cells
timeFrame: Up to 1 year
measure: Neutrophil
timeFrame: Up to 1 year
measure: Lymphocyte
timeFrame: Up to 1 year
measure: Platelet
timeFrame: Up to 1 year
measure: Neutrophil/lymphocyte ratio
timeFrame: Up to 1 year
measure: Platelet/lymphocyte ratio
timeFrame: Up to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Halil Okay Albayrak
state: İzmit
Study officials:
affiliation: Kocaeli University Department of Emergency Medicine
name: Serkan Yılmaz, Prof
role: STUDY_CHAIR
affiliation: Kocaeli University Department of Emergency Medicine
name: Serkan Yılmaz, Prof
role: STUDY_DIRECTOR
References:
citation: 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.