NCT04196127

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 6, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 6, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

1.6 years

First QC Date

December 6, 2019

Last Update Submit

December 10, 2019

Conditions

Keywords

Bite forceTemporomandibular disorderNeck pain

Outcome Measures

Primary Outcomes (1)

  • Maximum Bite Force

    Maximum bite force in Newton, best out of three tests

    baseline

Secondary Outcomes (4)

  • Bite Force Steadiness

    baseline

  • Neck muscle function

    baseline

  • Total Tenderness Score

    baseline

  • Total Tenderness Score

    Immediately after muscle function testing (outcomes 1-3)

Other Outcomes (3)

  • Numeric Pain Rating Scale

    baseline

  • Numeric Pain Rating Scale

    Immediately after muscle function testing (outcomes 1-3)

  • Prevalence of temporomandibular disorders

    baseline

Study Arms (2)

TTH

Patients with tension-type headache. They may not experience migraine, but can experience neck pain and/or temporomandibular dysfunction.

Other: Bite force testing

Healthy controls

Participants without frequent headaches. They may experience neck pain and/or temporomandibular dysfunction.

Other: Bite force testing

Interventions

Maximum bite force examination with a force intra-oral measuring device

Healthy controlsTTH

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danish Headache Center Rigshospitalet - Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

Related Publications (13)

  • 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.

    PMID: 21658987BACKGROUND
  • Ashina 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.

    PMID: 24853166BACKGROUND
  • Ballenberger 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.

    PMID: 28317439BACKGROUND
  • Bendtsen 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.

    PMID: 21735049BACKGROUND
  • Fernandez-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.

    PMID: 17366957BACKGROUND
  • Florencio 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.

    PMID: 26388193BACKGROUND
  • de 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.

    PMID: 30552819BACKGROUND
  • Madsen 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.

    PMID: 25834271BACKGROUND
  • Madsen 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.

    PMID: 29503581BACKGROUND
  • Testa 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.

    PMID: 26485381BACKGROUND
  • Testa 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.

    PMID: 30269020BACKGROUND
  • van 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.

    PMID: 28002094BACKGROUND
  • von 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.

    PMID: 27744136BACKGROUND

MeSH Terms

Conditions

Headache DisordersTension-Type HeadacheTemporomandibular Joint DisordersNeck Pain

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesHeadache Disorders, PrimaryCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bjarne Kjeldgaard Madsen, PT, PhD

    Danish Headache Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjarne Kjeldgaard Madsen, PT, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physiotherapist, PhD

Study Record Dates

First Submitted

December 6, 2019

First Posted

December 12, 2019

Study Start

December 6, 2019

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

December 12, 2019

Record last verified: 2019-12

Locations