Validation of the TMD Pain Screener in a Specialized Headache Center

NCT04193111 | Completed

• 1 other identifier: 061219
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorder; Headache Disorders

Keywords

orofacial pain; DC/TMD

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy

  Agreement on diagnoses expressed with sensitivity and specificity

  baseline

Study Arms (2)

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

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

Interventions

TMD pain screener DIAGNOSTIC_TEST

The danish TMD pain screener is given to all participants

Negative TMD pain screener; Positive TMD pain screener

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to the Danish Headache Center with any type of headache are included. Half the population has a high probability of having a painful TMD, the other half is matched on age and gender but has a low probability of having a painful TMD.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center Rigshospitalet - Glostrup

Glostrup Municipality, 2600, Denmark

Location

Related Publications (5)

• List T, Jensen RH. Temporomandibular disorders: Old ideas and new concepts. Cephalalgia. 2017 Jun;37(7):692-704. doi: 10.1177/0333102416686302. Epub 2017 Jan 9.

  PMID: 28068790 BACKGROUND

• Adern B, Minston A, Nohlert E, Tegelberg A. Self-reportance of temporomandibular disorders in adult patients attending general dental practice in Sweden from 2011 to 2013. Acta Odontol Scand. 2018 Oct;76(7):530-534. doi: 10.1080/00016357.2018.1487076. Epub 2018 Jun 22.

  PMID: 29932779 BACKGROUND

• Headache Classification Committee of the International Headache Society (IHS) The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018 Jan;38(1):1-211. doi: 10.1177/0333102417738202. No abstract available.

  PMID: 29368949 BACKGROUND

• List T, Ekberg C, Ernberg M, Svensson P, Alstergren P. Ny diagnostik för de vanligaste temporomandibulära dysfunktionerna för användning i allmäntandvården. Tandlægebladet 215; 119:268-276.

  BACKGROUND

• Schiffman E, Ohrbach R, Truelove E, Look J, Anderson G, Goulet JP, List T, Svensson P, Gonzalez Y, Lobbezoo F, Michelotti A, Brooks SL, Ceusters W, Drangsholt M, Ettlin D, Gaul C, Goldberg LJ, Haythornthwaite JA, Hollender L, Jensen R, John MT, De Laat A, de Leeuw R, Maixner W, van der Meulen M, Murray GM, Nixdorf DR, Palla S, Petersson A, Pionchon P, Smith B, Visscher CM, Zakrzewska J, Dworkin SF; International RDC/TMD Consortium Network, International association for Dental Research; Orofacial Pain Special Interest Group, International Association for the Study of Pain. Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications: recommendations of the International RDC/TMD Consortium Network* and Orofacial Pain Special Interest Groupdagger. J Oral Facial Pain Headache. 2014 Winter;28(1):6-27. doi: 10.11607/jop.1151.

  PMID: 24482784 BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Headache Disorders; Facial Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Henrik Winther Schytz, MD, PhD

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief medical officer, associate professor, MD, PhD

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 10, 2019
• Study Start: December 6, 2019
• Primary Completion: January 28, 2020
• Study Completion: January 28, 2020
• Last Updated: January 29, 2020

Record last verified: 2020-01

Locations

DK (1)