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

NCT ID: NCT05381129

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-10
• Study Completion Date: 2022-11-20

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Chronic migraine

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

Group Type: OTHER

Detection of Pain, Quality of Life, Sleep and Functioning

Intervention Type: OTHER

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

Temporomandibular dysfunction

Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3), and patients with temporomandibular dysfunction.

Group Type: OTHER

Detection of Pain, Quality of Life, Sleep and Functioning

Intervention Type: OTHER

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

Temporomandibular joint dysfunction

Intervention Type: OTHER

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

Interventions

Detection of Pain, Quality of Life, Sleep and Functioning

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

Intervention Type: OTHER

Temporomandibular joint dysfunction

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

Intervention Type: OTHER

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Alper mengi

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uğur Uygunoğlu, MD

Role: STUDY_DIRECTOR

Istanbul University - Cerrahpasa

Locations

Istanbul University- Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

26.04.2022/373110

Identifier Type: -

Identifier Source: org_study_id