Jaw Muscle Function in Patients With Tension-type Headache

December 10, 2019 updated by: Bjarne Kjeldgaard Madsen, Danish Headache Center

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TTH
Patients with tension-type headache. They may not experience migraine, but can experience neck pain and/or temporomandibular dysfunction.
Other: Bite force testing
Maximum bite force examination with a force intra-oral measuring device
Healthy controls
Participants without frequent headaches. They may experience neck pain and/or temporomandibular dysfunction.
Other: Bite force testing
Maximum bite force examination with a force intra-oral measuring device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Bite Force
Time Frame: baseline
Maximum bite force in Newton, best out of three tests
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bite Force Steadiness
Time Frame: baseline
30% of maximum bite force held for 30 seconds, expressed as mean and standard deviation
baseline
Neck muscle function
Time Frame: baseline
Ratio of flexion/extension strength
baseline
Total Tenderness Score
Time Frame: baseline
Overall total tenderness score (range 0 - 48; higher score means higher tenderness of the muscles).
baseline
Total Tenderness Score
Time Frame: Immediately after muscle function testing (outcomes 1-3)
Overall total tenderness score (range 0 - 48; higher score means higher tenderness of the muscles).
Immediately after muscle function testing (outcomes 1-3)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale
Time Frame: baseline
Pain intensity for headache, neck pain and jaw complaints (range 0 - 10; higher means more pain)
baseline
Numeric Pain Rating Scale
Time Frame: Immediately after muscle function testing (outcomes 1-3)
Pain intensity for headache, neck pain and jaw complaints (range 0 - 10; higher means more pain)
Immediately after muscle function testing (outcomes 1-3)
Prevalence of temporomandibular disorders
Time Frame: baseline
The prevalence of the different diagnoses of temporomandibular disorders, based on the diagnostic criteria for temporomandibular disorders.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danish Headache Center

Collaborators

UMC Utrecht
Academic Centre for Dentistry in Amsterdam

Investigators

  • Principal Investigator: Bjarne Kjeldgaard Madsen, PT, PhD, Danish Headache Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 6, 2019

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

December 6, 2019

First Submitted That Met QC Criteria

December 10, 2019

First Posted (Actual)

December 12, 2019

Study Record Updates

Last Update Posted (Actual)

December 12, 2019

Last Update Submitted That Met QC Criteria

December 10, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 091219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

It is not yet known if there will be a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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