Fibromyalgia Syndrome on Patients With Chronic Migraine

NCT05381012 | Completed

• 1 other identifier: 26.04.2022/372690
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (1)

• Descriptive information

  3 months

Study Arms (2)

Chronic migraine

OTHER

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

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 .

Other: Allodynia, quality of life, sleep, anxiety and depression, disability, and central sensitization; Other: Fibromyalgia syndrome

Interventions

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

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

Chronic migraine; Fibromyalgia syndrome

Fibromyalgia syndrome OTHER

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

Fibromyalgia syndrome

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache; Fibromyalgia; Headache Disorders

Interventions

Quality of Life; Sleep; Central Nervous System Sensitization

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Uğur Uygunoğlu, MD

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2022
• First Posted: May 19, 2022
• Study Start: May 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)