Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06304675
Status:
COMPLETED
Last Update Posted:
2024-03-12
First Post:
2024-02-06
Brief Title:
Manageable Environmental Factors in Migraine
Sponsor:
Samsun University
Organization:
Samsun University
Study Overview
Official Title:
Manageable Environmental Factors Affect Treatment Response as Much as Migraine Phenotype
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
There is limited and insufficient information on the effects of inappropriate living environments exposure to allergens electromagnetic fields and stress factors on the chronicity of migraine The aim of this study is to investigate the frequency of environmental variablestriggers in episodic and chronic migraine patients and their relationship with clinical variables in the chronic migraine group The results obtained will be shared not only in the scientific community but also on workplace health and employer-related platforms including Wellbeing groups
Detailed Description:
Migraines are a prevalent and debilitating neurological condition that can significantly impact a persons quality of life While various genetic and environmental factors contribute to the development and progression of migraines the role of specific environmental factorstriggers in the chronification of this condition remains inadequately explored This paper seeks to address this research gap by focusing on the impact of inadequate living environments exposure to allergens electromagnetic fields and stressors on the chronification of migraines
Obtaining specific trigger and headache information from a large number of migraineurs may provide a better understanding of which triggers are common andor strong and which may become important only when they act together 6 With studies focusing on this issue data that will even enable the identification of individuals with migraine who share a set of common triggers can be obtained
Migraine attacks often begin with an episodic course and may become chronic in some individuals over time due to reasons such as drug overuse various environmental factors and failure to take necessary steps in lifestyle regulation Exactly when chronicity will begin in each individual and how it will progress are related to these endogenous and exogenous factors as well as the genetic structure of the individual and how it will progress cannot be predicted
It is difficult to study the effect of triggers on migraine attacks Possible triggers may interact and statistical modeling is often difficult Therefore the estimated frequencies of precipitating factors vary considerably depending on the study approach and population There are very few studies investigating the effects of trigger and environmental factors on the migraine phenotype In a study where episodic and chronic migraine groups and triggerenvironmental factors were evaluated in 300 women with migraine Although some triggers have been defined for migraine no differentiation was observed between episodic and chronic migraine groups However in a study conducted in 2023 endogenous and exogenous factors that may have an effect on the chronicity of migraine were evaluated Although some triggersenvironmental factors have been identified as risk factors their likelihood of co-occurrence and clustering have not been evaluated in a large population
In this study the effects of triggers and environmental factors which investigators identified with a comprehensive inquiry form on both the pain phenotype and treatment response in migraine cases followed up in the same clinic including episodic and chronic migraine cases were evaluated It is aimed to show how these factors come together in the episodic and chronic migraine group and how this affects the fate of the patient as well as the fate of the pain Additionally the relationship between treatment options for migraine and the responses received and environmental factorstriggers was investigated Researching and defining all these features may be a good predictor in the chronicity of migraine which affects many individuals and in the regulation of environmental factorstriggers
Materials and Methods
Participants Patients who were over 18 years of age were followed up with a diagnosis of migraine and had the cognitive level to provide information about demographic and clinical features of headache were included International Classification of Headache Disorders-3 ICHD-3 criteria were used for the diagnosis of chronic migraine in the study group Having a headache more than 15 days per month for 3 months and having at least 8 headaches with migraine characteristics was defined as chronic migraine while those with headaches less frequently than 14 days per month were defined as episodic migraine All treatment options and responses received for migraine were recorded in detail Participants who agreed to participate in the study were given a survey form containing items about migraine characteristics triggers and environmental factors The data form was filled in through a face-to-face interview
22 Study Design Ethics approval was received for this cross-sectional-observational study OndokuzMayısUniversity-OMU-2023466 The International Headache Society IHS is involved in the development and publication of numerous guidelines for controlled treatment trials for primary headache disorders In the planning and implementation stages of this study the clinical trials guideline principles of the I IHS were followed and progress was made according to the STROBE checklist The demographic characteristics of the patients were recorded in the demographic data form Then the patients headache characteristics duration type presence of aura accompanying features etc and the answers to questions about possible triggers of migraine and environmental factors were recorded in the data form
Obtaining specific trigger and headache information from a large number of migraineurs may provide a better understanding of which triggers are common andor strong and which may become important only when they act together 6 With studies focusing on this issue data that will even enable the identification of individuals with migraine who share a set of common triggers can be obtained
Migraine attacks often begin with an episodic course and may become chronic in some individuals over time due to reasons such as drug overuse various environmental factors and failure to take necessary steps in lifestyle regulation Exactly when chronicity will begin in each individual and how it will progress are related to these endogenous and exogenous factors as well as the genetic structure of the individual and how it will progress cannot be predicted
It is difficult to study the effect of triggers on migraine attacks Possible triggers may interact and statistical modeling is often difficult Therefore the estimated frequencies of precipitating factors vary considerably depending on the study approach and population There are very few studies investigating the effects of trigger and environmental factors on the migraine phenotype In a study where episodic and chronic migraine groups and triggerenvironmental factors were evaluated in 300 women with migraine Although some triggers have been defined for migraine no differentiation was observed between episodic and chronic migraine groups However in a study conducted in 2023 endogenous and exogenous factors that may have an effect on the chronicity of migraine were evaluated Although some triggersenvironmental factors have been identified as risk factors their likelihood of co-occurrence and clustering have not been evaluated in a large population
In this study the effects of triggers and environmental factors which investigators identified with a comprehensive inquiry form on both the pain phenotype and treatment response in migraine cases followed up in the same clinic including episodic and chronic migraine cases were evaluated It is aimed to show how these factors come together in the episodic and chronic migraine group and how this affects the fate of the patient as well as the fate of the pain Additionally the relationship between treatment options for migraine and the responses received and environmental factorstriggers was investigated Researching and defining all these features may be a good predictor in the chronicity of migraine which affects many individuals and in the regulation of environmental factorstriggers
Materials and Methods
Participants Patients who were over 18 years of age were followed up with a diagnosis of migraine and had the cognitive level to provide information about demographic and clinical features of headache were included International Classification of Headache Disorders-3 ICHD-3 criteria were used for the diagnosis of chronic migraine in the study group Having a headache more than 15 days per month for 3 months and having at least 8 headaches with migraine characteristics was defined as chronic migraine while those with headaches less frequently than 14 days per month were defined as episodic migraine All treatment options and responses received for migraine were recorded in detail Participants who agreed to participate in the study were given a survey form containing items about migraine characteristics triggers and environmental factors The data form was filled in through a face-to-face interview
22 Study Design Ethics approval was received for this cross-sectional-observational study OndokuzMayısUniversity-OMU-2023466 The International Headache Society IHS is involved in the development and publication of numerous guidelines for controlled treatment trials for primary headache disorders In the planning and implementation stages of this study the clinical trials guideline principles of the I IHS were followed and progress was made according to the STROBE checklist The demographic characteristics of the patients were recorded in the demographic data form Then the patients headache characteristics duration type presence of aura accompanying features etc and the answers to questions about possible triggers of migraine and environmental factors were recorded in the data form
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None