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

Primary Purpose

Chronic Migraine, Headache, Temporomandibular Joint Dysfunction, Chronic Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Detection of Pain, Quality of Life, Sleep and Functioning
Temporomandibular joint dysfunction
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Migraine, Headache

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Istanbul University- Cerrahpasa

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Chronic migraine

Temporomandibular dysfunction

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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).
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.
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.
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.

Secondary Outcome Measures

Descriptive information
Patient'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.

Full Information

First Posted
May 14, 2022
Last Updated
September 26, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05381129
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
November 20, 2022 (Actual)
Study Completion Date
November 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Migraine, Headache, Temporomandibular Joint Dysfunction, Chronic Pain, Quality of Life, Sleep, Headache

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic migraine
Arm Type
Other
Arm Description
Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3).
Arm Title
Temporomandibular dysfunction
Arm Type
Other
Arm Description
Patients diagnosed with chronic migraine according to the International Headache Society Classification (ICHD-3), and patients with temporomandibular dysfunction.
Intervention Type
Other
Intervention Name(s)
Detection of Pain, Quality of Life, Sleep and Functioning
Intervention Description
All patients will be evaluated for allodynia, quality of life, headache-related disability, and sleep quality.
Intervention Type
Other
Intervention Name(s)
Temporomandibular joint dysfunction
Intervention Description
Patients with jaw complaints will be evaluated for temporomandibular joint dysfunction.
Primary Outcome Measure Information:
Title
Allodynia
Description
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.
Time Frame
7 days
Title
Health-Related Quality
Description
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.
Time Frame
7 days
Title
Headache-related disability
Description
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).
Time Frame
3 months
Title
The impact of headache on quality of life
Description
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.
Time Frame
3 months
Title
Sleep quality
Description
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.
Time Frame
7 days
Title
Temporomandibular dysfunction
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Descriptive information
Description
Patient'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.
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uğur Uygunoğlu, MD
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University- Cerrahpasa
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

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

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