Validation of the TMD Pain Screener in a Specialized Headache Center

Sponsor

Danish Headache Center (Other)

Overall Status

Completed

CT.gov ID

NCT04193111

Collaborator

(none)

Enrollment

Location

1.7

Actual Duration (Months)

28.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the study is to investigate whether a questionnaire can be used to detect whether patients referred to the Danish Headache Center have a painful temporomandibular disorder (TMD).

TMD is a major public health problem that affects up to 15% of the adult population and can cause headaches that can be immediately difficult to differentiate from other headache types such as tension headaches and migraines. By applying the so-called diagnostic criteria for TMD through a standardized study program, TMD diseases such as myalgia of the jaw muscles, arthralgia and discus displacements of the jaw joints and jaw arthritis can be diagnosed. However, this requires dental expertise and is time consuming. At the Danish Headache Center, the current screening question is used for TMD in order to identify who could benefit from further investigation in dentistry. But it is still unknown how accurate these questions are in selecting those patients who have TMD diseases in a patient group with a headache. The investigators would like to investigate this in order to improve the referral procedure of headache patients for relevant dental treatment or physiotherapy. This is believed to be of importance both in a specialized unit such as the Danish Headache Center and in neurological medical practice.

Patients will be recruited who are referred to the Danish Headache Center, who have been given TMD screening questions and who have indicated in writing that they wish to be contacted for research projects.

In the study, 25 subjects with TMD screening question score of ≥ 3 points will be included, which will be gender and age matched with 25 subjects who have TMD screening question score of <3 points. The patients will be interviewed to classify the patients headache 15 min and then have a jaw examination done and then the DC / TMD examination will be done and lasts approx. 30 min. The examination is performed by a skilled physiotherapist and it does not involve any side effects or risks.

Condition or Disease	Intervention/Treatment	Phase
Temporomandibular Disorder Headache Disorders	Diagnostic Test: TMD pain screener

Study Design

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

Validation of the Screening Questionnaire for Pain Attributed to Temporomandibular Disorders of Danish Headache Patients

Actual Study Start Date :

Dec 6, 2019

Actual Primary Completion Date :

Jan 28, 2020

Actual Study Completion Date :

Jan 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Positive TMD pain screener Patients who have ≥3 points on the TMD pain screener (0-7 range) are anticipated to have a painful TMD based on the DC/TMD and are therefore considered having a positive outcome on the TMD pain screener.	Diagnostic Test: TMD pain screener The danish TMD pain screener is given to all participants
Negative TMD pain screener Patients who have <3 points on the TMD pain screener (0-7 range) are anticipated NOT to have a painful TMD based on the DC/TMD and are therefore considered having a negative outcome on the TMD pain screener.	Diagnostic Test: TMD pain screener The danish TMD pain screener is given to all participants

Arm

Intervention/Treatment

Positive TMD pain screener

Patients who have ≥3 points on the TMD pain screener (0-7 range) are anticipated to have a painful TMD based on the DC/TMD and are therefore considered having a positive outcome on the TMD pain screener.

Diagnostic Test: TMD pain screener

The danish TMD pain screener is given to all participants

Negative TMD pain screener

Patients who have <3 points on the TMD pain screener (0-7 range) are anticipated NOT to have a painful TMD based on the DC/TMD and are therefore considered having a negative outcome on the TMD pain screener.

Diagnostic Test: TMD pain screener

The danish TMD pain screener is given to all participants

Outcome Measures

Primary Outcome Measures

Diagnostic Accuracy [baseline]
Agreement on diagnoses expressed with sensitivity and specificity

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Men and women between the ages of 18 and 75 who are referred to the Danish Headache Center

Exclusion Criteria:

No known pre-existing significant TMD or dental disease that can cause headaches
Anamnestic or clinical signs of a condition of any kind that is considered relevant by the investigating physician for participation in the study.
Patients who do not wish to be informed of the findings of presence of TMD