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

NCT05381129 | Completed

• 1 other identifier: 26.04.2022/373110
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• Temporomandibular dysfunction

  The 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.

  7 days

Secondary Outcomes (1)

• Descriptive information

  3 days

Study Arms (2)

Chronic migraine

OTHER

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

Other: Detection of Pain, Quality of Life, Sleep and Functioning

Temporomandibular dysfunction

OTHER

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

Other: Detection of Pain, Quality of Life, Sleep and Functioning; Other: Temporomandibular joint dysfunction

Interventions

Detection of Pain, Quality of Life, Sleep and Functioning OTHER

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

Chronic migraine; Temporomandibular dysfunction

Temporomandibular joint dysfunction OTHER

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

Temporomandibular dysfunction

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Headache; Temporomandibular Joint Disorders; Chronic Pain

Interventions

Quality of Life; Sleep; Functional Status

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

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 10, 2022
• Primary Completion: November 20, 2022
• Study Completion: November 20, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)