Chronic Migraine, HeadacheNCT05381012
Fibromyalgia Syndrome on Patients With Chronic Migraine
A study testing Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization and Fibromyalgia syndrome in people with Chronic Migraine, Headache and Fibromyalgia Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Chronic Migraine, Headache, Fibromyalgia Syndrome, Chronic Pain Syndrome
- What is being tested?
- Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization and Fibromyalgia syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Uncooperative
- Having congestive heart failure, chronic kidney failure, chronic liver disease, lung disease, uncontrolled diabetes, peripheral vascular disease
- Diagnosed with hypothyroidism or hyperthyroidism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Fibromyalgia Syndrome on Female Patients With Chronic Migraine
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.
Read the 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
- Being tested
- Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization, Fibromyalgia syndrome
- Medical subject headings
- Headache, Fibromyalgia, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitizationOther
All patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression, disability related to headache, and central sensitization.
Fibromyalgia syndromeOther
Patients who meet the diagnostic criteria for fibromyalgia syndrome will be evaluated with the Fibromyalgia Impact Questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Chronic migraine | Other | Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3). Receives: Other: Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization |
| Fibromyalgia syndrome | Other | Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3), and patients with fibromyalgia syndrome . Receives: Other: Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization; Other: Fibromyalgia syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days
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).
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 7 days
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.
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 May 2022
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Migraine, HeadacheStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper mengi, Istanbul University - Cerrahpasa
- Investigators
- Uğur Uygunoğlu, MD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05381012
- Sponsor's protocol ID
- 26.04.2022/372690
- Status last verified
- Sep 2023
- First submitted
- 14 May 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Fibromyalgia Syndrome on Female Patients With Chronic Migraine
- ClinicalTrials.gov ID
- NCT05381012
- Acronym / sponsor ID
- 26.04.2022/372690
- Conditions
- Chronic Migraine, Headache, Fibromyalgia Syndrome, Chronic Pain Syndrome, Central Sensitisation, Headache Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic migraine | Other | Other: Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitizationPatients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3). |
| Fibromyalgia syndrome | Other | Other: Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization, Other: Fibromyalgia syndromePatients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3), and patients with fibromyalgia syndrome . |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Being diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3)
- Being literate
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitizationAll patients will be evaluated for allodynia, quality of life, sleep, anxiety and depression, disability related to headache, and central sensitization. | Other | Chronic migraine, Fibromyalgia syndrome |
| Fibromyalgia syndromePatients who meet the diagnostic criteria for fibromyalgia syndrome will be evaluated with the Fibromyalgia Impact Questionnaire. | Other | Fibromyalgia syndrome |
Primary outcome
Central sensitization
Time frame: 7 days
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
Time frame: 3 months
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
Time frame: 3 months
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 7 days
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
Time frame: 1 month
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 secondary outcome
Descriptive information
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uğur Uygunoğlu, MD study director
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization and Fibromyalgia syndrome in people with Chronic Migraine, Headache and Fibromyalgia Syndrome, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Central sensitization (time frame: 7 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.