Validation of the TMD Pain Screener in a Specialized Headache Center

Completed

• Conditions: Temporomandibular Disorder; Headache Disorders
• Interventions: Diagnostic Test: TMD pain screener

• Registration Number: NCT04193111
• Lead Sponsor: Danish Headache Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-06
• Study First Submitted: 2019-12-06
• Study First Submitted QC: 2019-12-09
• Study First Posted: 2019-12-10
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-27
• Primary Completion: 2020-01-28
• Study Completion: 2020-01-28
• Last Update Posted: 2020-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Negative TMD pain screener	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.
Positive TMD pain screener	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.

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy	baseline	Agreement on diagnoses expressed with sensitivity and specificity

Trial Locations

Locations (1)

Danish Headache Center Rigshospitalet - Glostrup; 🇩🇰 Glostrup, Denmark