Fibromyalgia Syndrome on Patients With Chronic Migraine
Primary Purpose
Chronic Migraine, Headache, Fibromyalgia Syndrome, Chronic Pain Syndrome
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization
Fibromyalgia syndrome
Sponsored by
About this trial
This is an interventional diagnostic trial for Chronic Migraine, Headache
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
Sites / Locations
- Istanbul University- Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Chronic migraine
Fibromyalgia syndrome
Arm Description
Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3).
Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3), and patients with fibromyalgia syndrome .
Outcomes
Primary Outcome Measures
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.
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).
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.
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT05381012
First Posted
May 14, 2022
Last Updated
September 26, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05381012
Brief Title
Fibromyalgia Syndrome on Patients With Chronic Migraine
Official Title
The Effect of Fibromyalgia Syndrome on Female Patients With Chronic Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
November 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Headache, Fibromyalgia Syndrome, Chronic Pain Syndrome, Central Sensitisation, Headache Disorders
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chronic migraine
Arm Type
Other
Arm Description
Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3).
Arm Title
Fibromyalgia syndrome
Arm Type
Other
Arm Description
Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3), and patients with fibromyalgia syndrome .
Intervention Type
Other
Intervention Name(s)
Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization
Intervention Description
All patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression, disability related to headache, and central sensitization.
Intervention Type
Other
Intervention Name(s)
Fibromyalgia syndrome
Intervention Description
Patients who meet the diagnostic criteria for fibromyalgia syndrome will be evaluated with the Fibromyalgia Impact Questionnaire.
Primary Outcome Measure Information:
Title
Central sensitization
Description
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.
Time Frame
7 days
Title
Headache-related disability
Description
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).
Time Frame
3 months
Title
The impact of headache on quality of life
Description
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.
Time Frame
3 months
Title
Allodynia
Description
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.
Time Frame
7 days
Title
Health-Related Quality
Description
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.
Time Frame
7 days
Title
Sleep quality
Description
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.
Time Frame
7 days
Title
Anxiety and depression
Description
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.
Time Frame
7 days
Title
The quality of life and functional status of patients with fibromyalgia
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Descriptive information
Description
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.
Time Frame
3 months
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uğur Uygunoğlu, MD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University- Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Fibromyalgia Syndrome on Patients With Chronic Migraine
We'll reach out to this number within 24 hrs