Clinical trial NCT05381012: Fibromyalgia Syndrome on Patients With Chronic Migraine
Official title: The Effect of Fibromyalgia Syndrome on Female Patients With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine, Headache
Fibromyalgia Syndrome
Chronic Pain Syndrome
Central Sensitisation
Headache Disorders
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Central sensitization
timeFrame: 7 days
measure: Headache-related disability
timeFrame: 3 months
measure: The impact of headache on quality of life
timeFrame: 3 months
measure: Allodynia
timeFrame: 7 days
measure: Health-Related Quality
timeFrame: 7 days
measure: Sleep quality
timeFrame: 7 days
measure: Anxiety and depression
timeFrame: 7 days
measure: The quality of life and functional status of patients with fibromyalgia
timeFrame: 1 month
Secondary outcomes:
measure: Descriptive information
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Uğur Uygunoğlu, MD
role: STUDY_DIRECTOR
References: