Fibromyalgia Syndrome on Patients With Chronic Migraine

NCT ID: NCT05381012

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-01
• Study Completion Date: 2022-11-01

Brief Summary

The aim of this study to evaluate the effects of fibromyalgia syndrome accompanying women with chronic migraine on pain, quality of life, sleep, anxiety and depression, central sensitization and functionality.

Detailed Description

Patients who applied to Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Neurology, headache outpatient clinic and were diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3), after the patient's history and physical examination, will be included in the study.

Date of birth, education level, body mass index, occupation, marital status, socioeconomic status, age of onset of migraine complaints, descriptive information about migraine attacks (type (with or without aura), duration of attacks, average number of days with pain, pain severity, accompaniments) will be questioned.

In addition, if the fibromyalgia syndrome meets the diagnostic criteria, symptom duration and average body pain severity in the last 3 months will be questioned.

A total of 66 patients are planned to be included in the study. In the study, 2 groups will be formed, the first group will consist of chronic migraine patients, the second group will consist of patients with chronic migraine as well as fibromyalgia syndrome.

All patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression, disability related to headache, and central sensitization. Relevant forms will be filled by patients.

Patients will be evaluated with the diagnostic criteria for fibromyalgia syndrome and if the patients meet the diagnostic criteria for fibromyalgia syndrome, the Fibromyalgia Impact Questionnaire will be applied. The patient will be evaluated by Alper Mengi in terms of fibromyalgia syndrome diagnostic criteria.

Conditions

Chronic Migraine, Headache; Fibromyalgia Syndrome; Chronic Pain Syndrome; Central Sensitisation; Headache Disorders

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Chronic migraine

Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3).

Group Type: OTHER

Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization

Intervention Type: OTHER

All patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression, disability related to headache, and central sensitization.

Fibromyalgia syndrome

Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3), and patients with fibromyalgia syndrome .

Group Type: OTHER

Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization

Intervention Type: OTHER

All patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression, disability related to headache, and central sensitization.

Fibromyalgia syndrome

Intervention Type: OTHER

Patients who meet the diagnostic criteria for fibromyalgia syndrome will be evaluated with the Fibromyalgia Impact Questionnaire.

Interventions

Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization

All patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression, disability related to headache, and central sensitization.

Intervention Type: OTHER

Fibromyalgia syndrome

Patients who meet the diagnostic criteria for fibromyalgia syndrome will be evaluated with the Fibromyalgia Impact Questionnaire.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

For patients with chronic migraine:

• Being diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3)
• Being literate

For patients with fibromyalgia syndrome:

• Diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3)
• Being literate
• Diagnosed with fibromyalgia syndrome according to the 2016 American College of Rheumatology criteria

Exclusion Criteria

• Having another pathology that can explain their pain in the head and face region other than chronic migraine (such as sinusitis, tension-type headache, trigeminal neuralgia, drug overuse headache)
• Psychiatric disease or using psychiatric drugs
• History of serious head trauma or neurosurgical intervention
• History of infectious, chronic inflammatory disease, malignancy
• Pregnant and breastfeeding women
• History of additional neurological disease other than migraine
• Uncooperative
• Having congestive heart failure, chronic kidney failure, chronic liver disease, lung disease, uncontrolled diabetes, peripheral vascular disease
• Diagnosed with hypothyroidism or hyperthyroidism

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Alper mengi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uğur Uygunoğlu, MD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University- Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

26.04.2022/372690

Identifier Type: -

Identifier Source: org_study_id