Headache DisordersNCT04196127
Jaw Muscle Function in Patients With Tension-type Headache
An observational study of Headache Disorders and Tension-Type Headache, run by Danish Headache Center at 1 site in Denmark.
Trial summary
Patients with tension-type headache (TTH) and migraine often experience musculoskeletal complaints, like neck pain and/or jaw pain. Earlier studies have revealed an association between different headache types and neck pain and discussed the possible role of the cervical muscles. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Headache Disorders, Tension-Type Headache
- What is being tested?
- Bite force testing
- Type of treatment
- Pill or oral medicine
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 6 Dec 2019to 30 Jun 2021
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients will be recruited from the Danish Headache Center. Additionally the patients and healthy controls will be included from a Danish web page for trials www.forsoegsperson.dk and from a research data base in Danish Headache Center during 2019-2020. When the participants respond through the webpage through either mail or telephone, they will receive written information through mail. They will be informed that they have the right to take a family member or close related, And that the oral information will be postponed till all can participate.
Who may be able to join
- Age between 18 and 55 years old.
- Diagnosed Frequent episodic TTH (1-14 headache days / month) or chronic TTH (≥15 headache days/ month) based on the ICHD-3.
- Maximum 3 days of migraine per month.
- Signed informed acceptance of participation.
Who cannot join
- medication overuse headache (ICHD-3)
- missing more than 1 molar,
- previous whiplash or head trauma,
- other major physical or neurological diseases,
- diagnosed depression, other mental illness
- unable to understand and speak Danish.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Danish Headache Center Rigshospitalet - Glostrup
Glostrup Municipality, 2600
Bjarne K Madsen, phd stud., +45 60959493, bjarne.kjeldgaard.madsen@regionh.dk
About this study
Official title: Bite Force and Muscle Function in Patients With Tension-type Headache
Patients with tension-type headache (TTH) and migraine often experience musculoskeletal complaints, like neck pain and/or jaw pain. Earlier studies have revealed an association between different headache types and neck pain and discussed the possible role of the cervical muscles. Furthermore, patients with neck pain show a decrease in motor control of the jaw, without having any other signs of TMD. Similarly, studies in patients with TMD have only found an indication for poorer neck muscle function. Patients with TMD also show a decrease in bite force and force steadiness compared to healthy controls. It is however, unknown if bite force and force steadiness are similarly impaired in patients with headache and/or neck pain.
The current study will take a closer look at the jaw muscle function of in patients with TTH, with and without neck pain.
Read the detailed description
Tension-type headache (TTH) and migraine has been found to coincide with cervical pain, musculoskeletal dysfunction and/or temporomandibular disorders (TMD). The possible interplay between these three symptoms/disorders, headache, neck pain and TMD, have not been studied completely, only in sections. Earlier studies have revealed an association between different headache types and neck pain and discussed the possible role of the cervical muscles. Patients with TTH and (chronic) migraine exhibit lower muscle strength in the neck extensor muscles compared to healthy controls. Patients with neck pain show a decrease in motor control of the jaw, without having any other signs of TMD. Similarly, studies in patients with TMD have only found an indication for poorer neck muscle function while patients with TMD also show a decrease in bite force and force steadiness compared to healthy controls. It is however, unknown if bite force and force steadiness are similarly impaired in patients with headache and/or neck pain.
Muscle tenderness increases with increasing headache frequency and intensity in TTH while this association is not present in migraine patients. Tenderness has a significant influence on the neck muscle function in TTH patients and there is a negative correlation between Total Tenderness (TTS) and muscle force. There is currently, however, no clear understanding of the influence of tenderness on the function of jaw muscles in TTH patients.
The current project will increase the investigator's understanding of the interplay or dependency between the function of the jaw and neck muscles in TTH patients. If a comorbidity of TMD or neck pain make TTH patients more prone to dysfunction of jaw and neck muscles, this may lead to a subgrouping of these TTH patients. Together with the muscle function deficits discovered in the current case control study, this may suggest a targeted treatment for TTH to be tested in a follow up randomized control study.
- Conditions
- Headache Disorders, Tension-Type Headache
- Being tested
- Bite force testing
- Keywords
- Bite force, Temporomandibular disorder, Neck pain
- Medical subject headings
- Headache Disorders, Tension-Type Headache, Temporomandibular Joint Disorders, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bite force testingOther
Maximum bite force examination with a force intra-oral measuring device
| Study group | Role | What they receive |
|---|---|---|
| TTH | Patients with tension-type headache. They may not experience migraine, but can experience neck pain and/or temporomandibular dysfunction. Receives: Other: Bite force testing | |
| Healthy controls | Participants without frequent headaches. They may experience neck pain and/or temporomandibular dysfunction. Receives: Other: Bite force testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Bite Force
Maximum bite force in Newton, best out of three tests
Measured: baseline
Secondary outcomes (4)
Bite Force Steadiness
30% of maximum bite force held for 30 seconds, expressed as mean and standard deviation
Measured: baseline
Neck muscle function
Ratio of flexion/extension strength
Measured: baseline
Total Tenderness Score
Overall total tenderness score (range 0 - 48; higher score means higher tenderness of the muscles).
Measured: baseline
Total Tenderness Score
Overall total tenderness score (range 0 - 48; higher score means higher tenderness of the muscles).
Measured: Immediately after muscle function testing (outcomes 1-3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start6 Dec 2019 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Academic Centre for Dentistry in Amsterdam
- Responsible party
- Principal investigator, Bjarne Kjeldgaard Madsen, Danish Headache Center
- Investigators
- Bjarne Kjeldgaard Madsen, PT, PhD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196127
- Sponsor's protocol ID
- 091219
- Status last verified
- Dec 2019
- First submitted
- 6 Dec 2019
- Last updated
- 12 Dec 2019
- 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
Armijo-Olivo S, Warren S, Fuentes J, Magee DJ. Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example. Man Ther. 2011 Dec;16(6):563-72. doi: 10.1016/j.math.2011.05.006. Epub 2011 Jun 12.
PubMed 21658987Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia. 2015 Mar;35(3):211-9. doi: 10.1177/0333102414535110. Epub 2014 May 22.
PubMed 24853166Ballenberger N, von Piekartz H, Danzeisen M, Hall T. Patterns of cervical and masticatory impairment in subgroups of people with temporomandibular disorders-an explorative approach based on factor analysis. Cranio. 2018 Mar;36(2):74-84. doi: 10.1080/08869634.2017.1297904. Epub 2017 Mar 20.
PubMed 28317439Bendtsen L, Fernandez-de-la-Penas C. The role of muscles in tension-type headache. Curr Pain Headache Rep. 2011 Dec;15(6):451-8. doi: 10.1007/s11916-011-0216-0.
PubMed 21735049Fernandez-de-las-Penas C, Perez-de-Heredia M, Molero-Sanchez A, Miangolarra-Page JC. Performance of the craniocervical flexion test, forward head posture, and headache clinical parameters in patients with chronic tension-type headache: a pilot study. J Orthop Sports Phys Ther. 2007 Feb;37(2):33-9. doi: 10.2519/jospt.2007.2401.
PubMed 17366957Florencio LL, de Oliveira AS, Carvalho GF, Tolentino Gde A, Dach F, Bigal ME, Fernandez-de-las-Penas C, Bevilaqua Grossi D. Cervical Muscle Strength and Muscle Coactivation During Isometric Contractions in Patients With Migraine: A Cross-Sectional Study. Headache. 2015 Nov-Dec;55(10):1312-22. doi: 10.1111/head.12644. Epub 2015 Sep 21.
PubMed 26388193de Groot RJ, Wetzels JW, Merkx MAW, Rosenberg AJWP, de Haan AFJ, van der Bilt A, Abbink JH, Speksnijder CM. Masticatory function and related factors after oral oncological treatment: A 5-year prospective study. Head Neck. 2019 Jan;41(1):216-224. doi: 10.1002/hed.25445. Epub 2018 Dec 15.
PubMed 30552819Madsen BK, Sogaard K, Andersen LL, Skotte JH, Jensen RH. Neck and shoulder muscle strength in patients with tension-type headache: A case-control study. Cephalalgia. 2016 Jan;36(1):29-36. doi: 10.1177/0333102415576726. Epub 2015 Apr 1.
PubMed 25834271Madsen BK, Sogaard K, Andersen LL, Skotte J, Tornoe B, Jensen RH. Neck/shoulder function in tension-type headache patients and the effect of strength training. J Pain Res. 2018 Feb 23;11:445-454. doi: 10.2147/JPR.S146050. eCollection 2018.
PubMed 29503581Testa M, Geri T, Gizzi L, Petzke F, Falla D. Alterations in Masticatory Muscle Activation in People with Persistent Neck Pain Despite the Absence of Orofacial Pain or Temporomandibular Disorders. J Oral Facial Pain Headache. 2015 Fall;29(4):340-8. doi: 10.11607/ofph.1432.
PubMed 26485381Testa M, Geri T, Pitance L, Lentz P, Gizzi L, Erlenwein J, Petkze F, Falla D. Alterations in jaw clenching force control in people with myogenic temporomandibular disorders. J Electromyogr Kinesiol. 2018 Dec;43:111-117. doi: 10.1016/j.jelekin.2018.07.007. Epub 2018 Jul 26.
PubMed 30269020van der Meer HA, Speksnijder CM, Engelbert RHH, Lobbezoo F, Nijhuis-van der Sanden MWG, Visscher CM. The Association Between Headaches and Temporomandibular Disorders is Confounded by Bruxism and Somatic Symptoms. Clin J Pain. 2017 Sep;33(9):835-843. doi: 10.1097/AJP.0000000000000470.
PubMed 28002094von Piekartz H, Pudelko A, Danzeisen M, Hall T, Ballenberger N. Do subjects with acute/subacute temporomandibular disorder have associated cervical impairments: A cross-sectional study. Man Ther. 2016 Dec;26:208-215. doi: 10.1016/j.math.2016.09.001. Epub 2016 Sep 23.
PubMed 27744136
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bite Force and Muscle Function in Patients With Tension-type Headache
- ClinicalTrials.gov ID
- NCT04196127
- Acronym / sponsor ID
- 091219
- Conditions
- Headache Disorders, Tension-Type Headache
- Keywords
- Bite force, Temporomandibular disorder, Neck pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Collaborators
- UMC Utrecht, Academic Centre for Dentistry in Amsterdam
- Study start
- 6 Dec 2019 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 12 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.
Patients with tension-type headache (TTH) and migraine often experience musculoskeletal complaints, like neck pain and/or jaw pain. Earlier studies have revealed an association between different headache types and neck pain and discussed the possible role of the cervical muscles. Furthermore, patients with neck pain show a decrease in motor control of the jaw, without having any other signs of TMD. Similarly, studies in patients with TMD have only found an indication for poorer neck muscle function. Patients with TMD also show a decrease in bite force and force steadiness compared to healthy controls. It is however, unknown if bite force and force steadiness are similarly impaired in patients with headache and/or neck pain.
The current study will take a closer look at the jaw muscle function of in patients with TTH, with and without neck pain.
Detailed description
Tension-type headache (TTH) and migraine has been found to coincide with cervical pain, musculoskeletal dysfunction and/or temporomandibular disorders (TMD). The possible interplay between these three symptoms/disorders, headache, neck pain and TMD, have not been studied completely, only in sections. Earlier studies have revealed an association between different headache types and neck pain and discussed the possible role of the cervical muscles. Patients with TTH and (chronic) migraine exhibit lower muscle strength in the neck extensor muscles compared to healthy controls. Patients with neck pain show a decrease in motor control of the jaw, without having any other signs of TMD. Similarly, studies in patients with TMD have only found an indication for poorer neck muscle function while patients with TMD also show a decrease in bite force and force steadiness compared to healthy controls. It is however, unknown if bite force and force steadiness are similarly impaired in patients with headache and/or neck pain.
Muscle tenderness increases with increasing headache frequency and intensity in TTH while this association is not present in migraine patients. Tenderness has a significant influence on the neck muscle function in TTH patients and there is a negative correlation between Total Tenderness (TTS) and muscle force. There is currently, however, no clear understanding of the influence of tenderness on the function of jaw muscles in TTH patients.
The current project will increase the investigator's understanding of the interplay or dependency between the function of the jaw and neck muscles in TTH patients. If a comorbidity of TMD or neck pain make TTH patients more prone to dysfunction of jaw and neck muscles, this may lead to a subgrouping of these TTH patients. Together with the muscle function deficits discovered in the current case control study, this may suggest a targeted treatment for TTH to be tested in a follow up randomized control study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTH | – | Other: Bite force testingPatients with tension-type headache. They may not experience migraine, but can experience neck pain and/or temporomandibular dysfunction. |
| Healthy controls | – | Other: Bite force testingParticipants without frequent headaches. They may experience neck pain and/or temporomandibular dysfunction. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients will be recruited from the Danish Headache Center. Additionally the patients and healthy controls will be included from a Danish web page for trials www.forsoegsperson.dk and from a research data base in Danish Headache Center during 2019-2020. When the participants respond through the webpage through either mail or telephone, they will receive written information through mail. They will be informed that they have the right to take a family member or close related, And that the oral information will be postponed till all can participate.
Key inclusion criteria (4 listed)
- Age between 18 and 55 years old.
- Diagnosed Frequent episodic TTH (1-14 headache days / month) or chronic TTH (≥15 headache days/ month) based on the ICHD-3.
- Maximum 3 days of migraine per month.
- Signed informed acceptance of participation.
Key exclusion criteria (7 listed)
- medication overuse headache (ICHD-3)
- missing more than 1 molar,
- previous whiplash or head trauma,
- other major physical or neurological diseases,
- diagnosed depression, other mental illness
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 |
|---|---|---|
| Bite force testingMaximum bite force examination with a force intra-oral measuring device | Other | Healthy controls, TTH |
Primary outcome
Maximum Bite Force
Time frame: baseline
Maximum bite force in Newton, best out of three tests
4 secondary outcomes
Bite Force Steadiness
Time frame: baseline
Neck muscle function
Time frame: baseline
Total Tenderness Score
Time frame: baseline
Total Tenderness Score
Time frame: Immediately after muscle function testing (outcomes 1-3)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2019.
- Background: PubMed 21658987Armijo-Olivo S, Warren S, Fuentes J, Magee DJ. Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example. Man Ther. 2011 Dec;16(6):563-72. doi: 10.1016/j.math.2011.05.006. Epub 2011 Jun 12.
- Background: PubMed 24853166Ashina S, Bendtsen L, Lyngberg AC, Lipton RB, Hajiyeva N, Jensen R. Prevalence of neck pain in migraine and tension-type headache: a population study. Cephalalgia. 2015 Mar;35(3):211-9. doi: 10.1177/0333102414535110. Epub 2014 May 22.
- Background: PubMed 28317439Ballenberger N, von Piekartz H, Danzeisen M, Hall T. Patterns of cervical and masticatory impairment in subgroups of people with temporomandibular disorders-an explorative approach based on factor analysis. Cranio. 2018 Mar;36(2):74-84. doi: 10.1080/08869634.2017.1297904. Epub 2017 Mar 20.
- Background: PubMed 21735049Bendtsen L, Fernandez-de-la-Penas C. The role of muscles in tension-type headache. Curr Pain Headache Rep. 2011 Dec;15(6):451-8. doi: 10.1007/s11916-011-0216-0.
- Background: PubMed 17366957Fernandez-de-las-Penas C, Perez-de-Heredia M, Molero-Sanchez A, Miangolarra-Page JC. Performance of the craniocervical flexion test, forward head posture, and headache clinical parameters in patients with chronic tension-type headache: a pilot study. J Orthop Sports Phys Ther. 2007 Feb;37(2):33-9. doi: 10.2519/jospt.2007.2401.
- Background: PubMed 26388193Florencio LL, de Oliveira AS, Carvalho GF, Tolentino Gde A, Dach F, Bigal ME, Fernandez-de-las-Penas C, Bevilaqua Grossi D. Cervical Muscle Strength and Muscle Coactivation During Isometric Contractions in Patients With Migraine: A Cross-Sectional Study. Headache. 2015 Nov-Dec;55(10):1312-22. doi: 10.1111/head.12644. Epub 2015 Sep 21.
- Background: PubMed 30552819de Groot RJ, Wetzels JW, Merkx MAW, Rosenberg AJWP, de Haan AFJ, van der Bilt A, Abbink JH, Speksnijder CM. Masticatory function and related factors after oral oncological treatment: A 5-year prospective study. Head Neck. 2019 Jan;41(1):216-224. doi: 10.1002/hed.25445. Epub 2018 Dec 15.
- Background: PubMed 25834271Madsen BK, Sogaard K, Andersen LL, Skotte JH, Jensen RH. Neck and shoulder muscle strength in patients with tension-type headache: A case-control study. Cephalalgia. 2016 Jan;36(1):29-36. doi: 10.1177/0333102415576726. Epub 2015 Apr 1.
- Background: PubMed 29503581Madsen BK, Sogaard K, Andersen LL, Skotte J, Tornoe B, Jensen RH. Neck/shoulder function in tension-type headache patients and the effect of strength training. J Pain Res. 2018 Feb 23;11:445-454. doi: 10.2147/JPR.S146050. eCollection 2018.
- Background: PubMed 26485381Testa M, Geri T, Gizzi L, Petzke F, Falla D. Alterations in Masticatory Muscle Activation in People with Persistent Neck Pain Despite the Absence of Orofacial Pain or Temporomandibular Disorders. J Oral Facial Pain Headache. 2015 Fall;29(4):340-8. doi: 10.11607/ofph.1432.
- Background: PubMed 30269020Testa M, Geri T, Pitance L, Lentz P, Gizzi L, Erlenwein J, Petkze F, Falla D. Alterations in jaw clenching force control in people with myogenic temporomandibular disorders. J Electromyogr Kinesiol. 2018 Dec;43:111-117. doi: 10.1016/j.jelekin.2018.07.007. Epub 2018 Jul 26.
- Background: PubMed 28002094van der Meer HA, Speksnijder CM, Engelbert RHH, Lobbezoo F, Nijhuis-van der Sanden MWG, Visscher CM. The Association Between Headaches and Temporomandibular Disorders is Confounded by Bruxism and Somatic Symptoms. Clin J Pain. 2017 Sep;33(9):835-843. doi: 10.1097/AJP.0000000000000470.
- 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.
Bjarne Kjeldgaard Madsen, PT, 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 Headache Disorders and Tension-Type Headache, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 12 Dec 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bjarne Kjeldgaard Madsen, PT, PhD (+45 38 63 22 24, bjarne.kjeldgaard.madsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Bite Force (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 NCT04196127, which also lists 13 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 12 Dec 2019.