Assessment of Inflammation in Primary Headaches

Sponsor

Kocaeli University (Other)

Overall Status

Completed

CT.gov ID

NCT04891848

Collaborator

(none)

230

Enrollment

Location

Actual Duration (Months)

17.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Headache Disorders	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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

230 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Assessment of Inflammation With Haematological Parameters in Patients With Migraine and Tension Type Headache: a Prospective Study From a Tertiary Care Center

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

May 31, 2019

Actual Study Completion Date :

May 31, 2019

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

White blood cells [Up to 1 year]
White blood cells (x10³/μL) counted in complete blood count and compared between patients and healthy controls
Neutrophil [Up to 1 year]
Neutrophil (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Lymphocyte [Up to 1 year]
Lymphocyte (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Platelet [Up to 1 year]
Platelet (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Neutrophil/lymphocyte ratio [Up to 1 year]
Neutrophil/lymphocyte ratio calculated by dividing absolute neutrophil to absolute lymphocyte and compared between patients and healthy controls.
Platelet/lymphocyte ratio [Up to 1 year]
Platelet/lymphocyte ratio calculated by dividing absolute platelet to absolute lymphocyte and compared between patients and healthy controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Halil Okay Albayrak	Kocaeli	İzmit	Turkey	41100

Sponsors and Collaborators

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