Jaw Muscle Function in Patients With Tension-type Headache

Tension-Type Headache Clinical Trial

Official title:

Bite Force and Muscle Function in Patients With Tension-type Headache

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04196127
• Other study ID #: 091219
• Status: Recruiting
• Start date: December 6, 2019
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2019
• Source: Danish Headache Center
• Contact: Bjarne Kjeldgaard Madsen, PT, PhD
• Phone: +45 38 63 22 24
• Email: bjarne.kjeldgaard.madsen[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Headache
• Headache Disorders
• Tension-Type Headache

Intervention

Other:
• Bite force testing
Maximum bite force examination with a force intra-oral measuring device

Locations

Country	Name	City	State
Denmark	Danish Headache Center Rigshospitalet - Glostrup	Glostrup

Sponsors (3)

Lead Sponsor	Collaborator
Danish Headache Center	Academic Centre for Dentistry in Amsterdam, UMC Utrecht

Country where clinical trial is conducted

Denmark, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Bendtsen L, Fernández-de-la-Peñas 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. Review. — View Citation

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. — View Citation

Fernandez-de-las-Peñas C, Pérez-de-Heredia M, Molero-Sánchez 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. — View Citation

Florencio LL, de Oliveira AS, Carvalho GF, Tolentino Gde A, Dach F, Bigal ME, Fernández-de-las-Peñas 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. — View Citation

Madsen BK, Søgaard K, Andersen LL, Skotte J, Tornøe 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. — View Citation

Madsen BK, Søgaard 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Numeric Pain Rating Scale	Pain intensity for headache, neck pain and jaw complaints (range 0 - 10; higher means more pain)	baseline
Other	Numeric Pain Rating Scale	Pain intensity for headache, neck pain and jaw complaints (range 0 - 10; higher means more pain)	Immediately after muscle function testing (outcomes 1-3)
Other	Prevalence of temporomandibular disorders	The prevalence of the different diagnoses of temporomandibular disorders, based on the diagnostic criteria for temporomandibular disorders.	baseline
Primary	Maximum Bite Force	Maximum bite force in Newton, best out of three tests	baseline
Secondary	Bite Force Steadiness	30% of maximum bite force held for 30 seconds, expressed as mean and standard deviation	baseline
Secondary	Neck muscle function	Ratio of flexion/extension strength	baseline
Secondary	Total Tenderness Score	Overall total tenderness score (range 0 - 48; higher score means higher tenderness of the muscles).	baseline
Secondary	Total Tenderness Score	Overall total tenderness score (range 0 - 48; higher score means higher tenderness of the muscles).	Immediately after muscle function testing (outcomes 1-3)