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The Effect of Accompanying Temporomandibular Joint Dysfunction in Patients With Chronic Migraine

The Effect of Accompanying Temporomandibular Joint Dysfunction on Pain, Quality of Life, Sleep and Functionality in Patients With Chronic Migraine

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05381129
Enrollment
62
Registered
2022-05-19
Start date
2022-05-10
Completion date
2022-11-20
Last updated
2023-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Migraine, Headache, Chronic Pain, Headache, Quality of Life, Sleep, Temporomandibular Joint Dysfunction

Brief summary

The aim of this clinical study to evaluate the effect of temporomandibular joint dysfunction accompanying patients with chronic migraine on pain, quality of life, sleep and functionality.

Detailed description

Patients who applied to Istanbul University - Cerrahpasa, Cerrahpasa 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, gender, 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, mean number of days with pain) , pain intensity, accompanying) will be questioned. In addition, patients with complaints and findings such as pain in the temporomandibular joint area and chewing muscles, limitation in mouth opening, noise from the joint during mouth opening and/or non-harmonic jaw movements will be evaluated by Alper Mengi in terms of temporomandibular joint dysfunction. A total of 62 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 temporomandibular joint dysfunction. All patients will be evaluated for allodynia, quality of life, headache-related disability, and sleep quality. Relevant forms will be filled by patients. Patients who are thought to have temporomandibular joint dysfunction will be evaluated by Alper Mengi for dysfunction.

Interventions

OTHERDetection of Pain, Quality of Life, Sleep and Functioning

All patients will be evaluated for allodynia, quality of life, headache-related disability, and sleep quality.

OTHERTemporomandibular joint dysfunction

Patients with jaw complaints will be evaluated for temporomandibular joint dysfunction.

Sponsors

Istanbul University - Cerrahpasa
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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 temporomandibular dysfunction : * Diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3) * Being literate * Pain in the temporomandibular joint region and chewing muscles for at least 3 months, limitation in mouth opening, noise from the joint when opening the mouth, and / or having complaints and findings such as non-harmonic jaw movements * Getting a score of ≥1 according to the Helkimo Clinical Craniomandibular Dysfunction Index

Exclusion criteria

For patients with chronic migraine: * Complaint of chronic pain in another part of their body other than the head and face region * 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 * Those with a 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 In addition to the

Design outcomes

Primary

MeasureTime frameDescription
Headache-related disability3 monthsThe 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).
Allodynia7 daysThe 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 Quality7 daysThe 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.
Temporomandibular dysfunction7 daysThe patients will be evaluated for temporomandibular dysfunction with Helkimo Clinical Dysfunction Index. This index include the following signs: impaired range of movement of the mandible, impaired function of the joint, pain with movement of the mandible, muscle pain, and joint pain. Patients are given a score of 0 points for absence of symptoms, 1 point for mild pain or dysfunction, and 5 points for severe pain or dysfunction.
The impact of headache on quality of life3 monthsThe 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.
Sleep quality7 daysThe 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.

Secondary

MeasureTime frameDescription
Descriptive information3 daysPatient's date of birth, gender, 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, severity of pain , companions) will be questioned.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026