Validation of the TMD Pain Screener in a Specialized Headache Center

NCT ID: NCT04193111

Last Updated: 2020-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-06

Study Completion Date

2020-01-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temporomandibular Disorder Headache Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

TMD pain screener

Intervention Type DIAGNOSTIC_TEST

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.

TMD pain screener

Intervention Type DIAGNOSTIC_TEST

The danish TMD pain screener is given to all participants

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TMD pain screener

The danish TMD pain screener is given to all participants

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Henrik Schytz

Chief medical officer, associate professor, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Henrik Winther Schytz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Danish Headache Center Rigshospitalet - Glostrup

Glostrup Municipality, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 28068790 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29932779 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29368949 (View on PubMed)

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.

Reference Type 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.

Reference Type BACKGROUND
PMID: 24482784 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

061219

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Migraine in Adolescents
NCT05654012 RECRUITING NA