Temporomandibular DisorderNCT04193111
Validation of the TMD Pain Screener in a Specialized Headache Center
An observational study of Temporomandibular Disorder and Headache Disorders, run by Danish Headache Center at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Disorder, Headache Disorders
- What is being tested?
- TMD pain screener
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Dec 2019to 28 Jan 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Men and women between the ages of 18 and 75 who are referred to the Danish Headache Center
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Danish Headache Center Rigshospitalet - Glostrup
Glostrup Municipality, 2600
About this study
Official title: Validation of the Screening Questionnaire for Pain Attributed to Temporomandibular Disorders of Danish Headache Patients
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.
Read more
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
- Being tested
- TMD pain screener
- Keywords
- orofacial pain, DC/TMD
- Medical subject headings
- Temporomandibular Joint Disorders, Headache Disorders, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMD pain screenerDiagnostic test
The danish TMD pain screener is given to all participants
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: TMD pain screener |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy
Agreement on diagnoses expressed with sensitivity and specificity
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start6 Dec 2019
- Primary completion28 Jan 2020
- Study completion28 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Schytz, Danish Headache Center
- Investigators
- Henrik Winther Schytz, MD, PhD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193111
- Sponsor's protocol ID
- 061219
- Status last verified
- Jan 2020
- First submitted
- 6 Dec 2019
- Last updated
- 29 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available
Publications
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.
PubMed 28068790Adern 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.
PubMed 29932779Headache 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.
PubMed 29368949List 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.
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.
PubMed 24482784
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Screening Questionnaire for Pain Attributed to Temporomandibular Disorders of Danish Headache Patients
- ClinicalTrials.gov ID
- NCT04193111
- Acronym / sponsor ID
- 061219
- Conditions
- Temporomandibular Disorder, Headache Disorders
- Keywords
- orofacial pain, DC/TMD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 6 Dec 2019 (actual)
- Primary completion
- 28 Jan 2020 (actual)
- Study completion
- 28 Jan 2020 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive TMD pain screener | – | Diagnostic Test: TMD pain screenerPatients 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. |
| Negative TMD pain screener | – | Diagnostic Test: TMD pain screenerPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Men and women between the ages of 18 and 75 who are referred to the Danish Headache Center
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMD pain screenerThe danish TMD pain screener is given to all participants | Diagnostic test | Negative TMD pain screener, Positive TMD pain screener |
Primary outcome
Diagnostic Accuracy
Time frame: baseline
Agreement on diagnoses expressed with sensitivity and specificity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2020.
- Background: PubMed 28068790List 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.
- Background: PubMed 29932779Adern 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.
- Background: PubMed 29368949Headache 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.
- BackgroundList 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: PubMed 24482784Schiffman 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.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Winther Schytz, MD, PhD principal investigator
Danish Headache Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorder and Headache Disorders, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Accuracy (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04193111, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2020.