Fibromyalgia Syndrome on Patients With Chronic Migraine

Chronic Pain Syndrome Clinical Trial

Official title:

The Effect of Fibromyalgia Syndrome on Female Patients With Chronic Migraine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05381012
• Other study ID #: 26.04.2022/372690
• Status: Completed
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: September 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Sensitisation
• Chronic Migraine, Headache
• Chronic Pain
• Chronic Pain Syndrome
• Fibromyalgia
• Fibromyalgia Syndrome
• Headache
• Headache Disorders
• Migraine Disorders
• Myofascial Pain Syndromes
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University- Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central sensitization	The patients will be evaluated for central sensitization with Central Sensitization Inventory. The Central Sensitization Inventory assesses 25 health-related symptoms. Responses are recorded about the frequency of each symptom, with a Likert scale from 0 (never) to 4 (always), resulting in a total possible score of 100. Higher scores are associated with a higher degree of self-reported symptomology.	7 days
Primary	Headache-related disability	The patients will be evaluated for headache-related disability with The Migraine Disability Assessment Test. Migraine Disability Assessment scores (numerical scores represent number of days patients missed or lost productivity at work or school, as well as missed days from family/social/leisure activities, and range from little or no disability (0-5) to severe disability (>20).	3 months
Primary	The impact of headache on quality of life	The patients will be evaluated for the impact of headache on quality of life with 6-item short-form Headache Impact Test. This test is a patient-reported outcome measure used to measure the impact and effect of headache on the ability to function normally in daily life. It consists of 6 questions, total scores may range from 36 to 78 and higher scores reflecting greater impact.	3 months
Primary	Allodynia	The patients will be evaluated for allodynia with the Allodynia Symptom Checklist. The Allodynia Symptom Checklist include 12 questions about the frequency of various allodynia symptoms in association with headache attacks. Instead of using a dichotomous option (yes or no), the response categories are "never," "rarely," "less than half the time," and "half the time or more." In addition, subjects can also indicate that an item "does not apply to me." That option is used by someone who never shaved their face or someone who never wore a ponytail.	7 days
Primary	Health-Related Quality	The patients will be evaluated for the quality of life with The Short Form-36. This form is composed of 36 items and eight subscales to evaluate quality of life (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). The scores of the subscales range between 0 and 100, and higher scores indicate higher quality of life.	7 days
Primary	Sleep quality	The patients will be evaluated for sleep quality with the Pittsburgh Sleep Quality Index. It contains 19 self-reported items and 5 items to be completed by a bed partner or roommate, if possible. Scores range from 0 to 3, and are summed to obtain a global score, which ranges from 0 to 21. Higher scores indicate greater sleep disturbance.	7 days
Primary	Anxiety and depression	The patients will be evaluated for anxiety and depression with Hospital Anxiety and Depression Scale. The scale is a fourteen-item scale with seven items each for anxiety and depression subscales. Scoring for each item ranges from zero to three. A subscale score >8 denotes anxiety or depression.	7 days
Primary	The quality of life and functional status of patients with fibromyalgia	The quality of life and functional status of patients with fibromyalgia syndrome will be evaluated with the Fibromyalgia Impact Questionnaire. In this scale, 10 different characteristics are measured, including physical function, well-being, inability to work, difficulty at work, pain, fatigue, morning tiredness, stiffness, anxiety, and depression. The maximum score is 100, and increased score represents decreased functionality.	1 month
Secondary	Descriptive information	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 patient meets the diagnostic criteria of fibromyalgia syndrome, symptom duration and average body pain severity in the last 3 months will be questioned.	3 months