Clinical trial NCT03626805: Muscle Tenderness and Hardness in Migraine Patients
Official title: Muscle Tenderness and Hardness in Migraine Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Muscle Tenderness
Headache Disorders, Primary
Nervous System Diseases
Headache, Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migraine patients are recruited from the out-patient clinic at the Danish Headache Center.

Healthy controls are recruited through web-sites.

Brief summary: The aim of the study is to examine symptomatology, quantitative sensory test (QST) parameters, muscle tenderness and muscle hardness in migraine patients interictally and compare with healthy controls

Detailed description: Migraine patients exhibit different symptomatology and responses to treatment. For example do many migraine patients have neck symptoms, despite they apparently do not have any neck disorders.Furthermore the response to treatment differs between patients. Differences in symptomatology, QST parameters and muscle stiffness can be used to subdivide and phenotype migraine patients.

The investigators are examining migraine patients with:

A semistructured interview, Quantitative sensory testing (cold pain threshold, heat pain threshold and Pin Prick), Muscle tenderness (total tenderness score, local tenderness score and stimulus response curve), and muscle hardness with ultrasound elastography. All tests are performed the same day

Eligibility criteria: Inclusion Criteria:

* Migraine Patients from the Danish Headache Centre. Migraine classified using the International Classification of Headache Disorders (ICHD3) criteria.

Exclusion Criteria:

* Pregnant or lactating women
* Musculoskeletal injuries in the neck or shoulder
* Other primary headache disorders than migraine or Tension Type Headache
* On the time of examination: Migraine free for at least 48 hours
* On the time of examination: haven't trained the upper body for at least 48 hours
* On the time of examination: haven't used painkillers for at least 48 hours

Healthy controls:

Exclusion Criteria:

* Pregnant or lactating women
* Musculoskeletal injuries in the neck or shoulder
* Migraine disorders
* 1. degree relatives with migraine disorders
* Over 1 day of tension type headache a month.
* On the time of examination: haven't trained the upper body for at least 48 hours
* On the time of examination: haven't used painkillers for at least 48 hours

Primary outcomes:
measure: Logistic regression model, Neck Stiffness
timeFrame: 3 hours
measure: Pericranial Muscle Tenderness
timeFrame: 3 hours
measure: Muscle Hardness measured by ultrasound elastography
timeFrame: 3 hours
measure: Muscle hardness measured by ultrasound elastography in migaine patients
timeFrame: 3 hours
Secondary outcomes:
measure: Multiple Regression model, Total Tenderness Score
timeFrame: 3 hours
measure: Logistic regression model, Neck pain in general
timeFrame: 3 hours
measure: Next migraine attack, Cox proportional hazards model
timeFrame: 3 hours
Other outcomes:
measure: Correlation analysis of muscle hardness and headache frequency
timeFrame: 3 hours
measure: Correlation analysis of muscle hardness and muscle tenderness assessed with the total tenderness score.
timeFrame: 3 hours
measure: Correlation analysis of muscle hardness and pressure pain threshold assessed with an pressure algometer.
timeFrame: 3 hours
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
affiliation: Danish Headache Center
name: Jeppe H Mann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hvedstrup J, Kolding LT, Ashina M, Schytz HW. Increased neck muscle stiffness in migraine patients with ictal neck pain: A shear wave elastography study. Cephalalgia. 2020 May;40(6):565-574. doi: 10.1177/0333102420919998. Epub 2020 Apr 15.