Headache DisordersNCT04891848
Assessment of Inflammation in Primary Headaches
An observational study of Headache Disorders, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache Disorders
- What is being tested?
- inflammation
- How many people
- 230 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2018to 31 May 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Migraine and tension-type headache patients who admitted to emergency department with an acute headache attack
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Headache Disorders
- Being tested
- inflammation
- Keywords
- primary headache, migraine with aura, migraine without aura, tension type headache, inflammation, neuroinflammation
- Medical subject headings
- Headache Disorders, Migraine with Aura, Migraine without Aura, Tension-Type Headache, Inflammation, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inflammationOther
inflammatory values in complete blood count (CBC)
| Study group | Role | What they receive |
|---|---|---|
| migraine with aura | 51 patients with MA Receives: Other: inflammation | |
| migraine without aura | 51 patients with migraine without aura Receives: Other: inflammation | |
| tension type headache | 48 patients with tension type headache Receives: Other: inflammation | |
| healthy controls | 80 healthy participants Receives: Other: inflammation |
What is being measured
The primary outcome is the main question the study is designed to answer.
White blood cells
White blood cells (x10³/μL) counted in complete blood count and compared between patients and healthy controls
Measured: Up to 1 year
Neutrophil
Neutrophil (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Measured: Up to 1 year
Lymphocyte
Lymphocyte (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Measured: Up to 1 year
Platelet
Platelet (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Measured: 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.
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start1 May 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Okay Albayrak, Kocaeli University
- Investigators
- Serkan Yılmaz, Prof, Study chair, Kocaeli University Department of Emergency MedicineSerkan Yılmaz, Prof, Study director, Kocaeli University Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891848
- Sponsor's protocol ID
- KOU/KAE: 2018/192
- Status last verified
- May 2021
- First submitted
- 20 Apr 2021
- Last updated
- 19 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34431322
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Inflammation With Haematological Parameters in Patients With Migraine and Tension Type Headache: a Prospective Study From a Tertiary Care Center
- ClinicalTrials.gov ID
- NCT04891848
- Acronym / sponsor ID
- KOU/KAE: 2018/192
- Conditions
- Headache Disorders
- Keywords
- primary headache, migraine with aura, migraine without aura, tension type headache, inflammation, neuroinflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| migraine with aura | – | Other: inflammation51 patients with MA |
| migraine without aura | – | Other: inflammation51 patients with migraine without aura |
| tension type headache | – | Other: inflammation48 patients with tension type headache |
| healthy controls | – | Other: inflammation80 healthy participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Migraine and tension-type headache patients who admitted to emergency department with an acute headache attack
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Secondary headaches
- Chronic inflammatory disorders
- Infectious diseases
- Hematologic abnormalities
- A prior history of surgery (within the preceding 6 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inflammationinflammatory values in complete blood count (CBC) | Other | healthy controls, migraine with aura, migraine without aura, tension type headache |
Primary outcome
White blood cells
Time frame: Up to 1 year
White blood cells (x10³/μL) counted in complete blood count and compared between patients and healthy controls
Neutrophil
Time frame: Up to 1 year
Neutrophil (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Lymphocyte
Time frame: Up to 1 year
Lymphocyte (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Platelet
Time frame: Up to 1 year
Platelet (x10³/μL) levels counted in complete blood count and compared between patients and healthy controls
Neutrophil/lymphocyte ratio
Time frame: 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
Time frame: Up to 1 year
Platelet/lymphocyte ratio calculated by dividing absolute platelet to absolute lymphocyte and compared between patients and healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
- Derived from this study: PubMed 34431322Albayrak 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Serkan Yılmaz, Prof study chair
Kocaeli University Department of Emergency Medicine
Serkan Yılmaz, Prof study director
Kocaeli University Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Headache Disorders, run by Kocaeli University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
White blood cells (time frame: Up to 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04891848, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.