Clinical trial NCT05381129: The Effect of Accompanying Temporomandibular Joint Dysfunction in Patients With Chronic Migraine
Official title: The Effect of Accompanying Temporomandibular Joint Dysfunction on Pain, Quality of Life, Sleep and Functionality in Patients With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Migraine, Headache
Temporomandibular Joint Dysfunction
Chronic Pain
Quality of Life
Sleep
Headache
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-05-19
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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 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 exclusion criteria above in patients with a diagnosis of temporomandibular joint dysfunction:

* Presence of trauma or operation in the temporomandibular joint
* History of facial paralysis
* Actively receiving treatment related to the temporomandibular joint

Primary outcomes:
measure: Allodynia
timeFrame: 7 days
measure: Health-Related Quality
timeFrame: 7 days
measure: Headache-related disability
timeFrame: 3 months
measure: The impact of headache on quality of life
timeFrame: 3 months
measure: Sleep quality
timeFrame: 7 days
measure: Temporomandibular dysfunction
timeFrame: 7 days
Secondary outcomes:
measure: Descriptive information
timeFrame: 3 days
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Uğur Uygunoğlu, MD
role: STUDY_DIRECTOR
References: