An observational study in Migraine Disorders, Muscle Tenderness and Headache Disorders, Primary, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-29.
Sponsored by Danish Headache Center · Observational
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
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
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's enrollment of 146 is close to the median of 137 across 331 observational studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Danish Headache Center is the lead sponsor of 129 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Migraine patients are recruited from the out-patient clinic at the Danish Headache Center.
Healthy controls are recruited through web-sites.
Inclusion Criteria:
Exclusion Criteria:
Healthy controls:
Exclusion Criteria:
Migraine patients attending the Danish Headache Centre
Age and sex matched
Logistic regression model, Neck Stiffness
We would like to examine the relationship between the variable variable: Neck stiffness during migraine attack (Yes/No) and the Independent variables: Total Tenderness Score (summed score from 8 points bilateral, each point can score 0-3), Migraine localisation (occipital: Yes/No), Tension Type Headache, Allodynia (yes/No), Stimulus response curve (Pressure and Pain). The result shows how much of the variability in neck stiffness that can be explained by the independent variables.
Time frame: 3 hours
Pericranial Muscle Tenderness
We will examine whether patients with neck stiffness during migraine attack (yes/no) have higher tenderness scores compared to patients without neck stiffness during migraine attacks, when correcting for headache frequency.
Time frame: 3 hours
Muscle Hardness measured by ultrasound elastography
Muscle hardness (m/s) in migraine patients compared to healthy controls.corrected for age, BMI and sex
Time frame: 3 hours
Muscle hardness measured by ultrasound elastography in migaine patients
Muscle hardness (m/s) in migraine patients with neck stiffness during migraine attacks compared to migraine patients without neck stiffness during migraine attacks. Corrected for age, BMI and sex.
Time frame: 3 hours
Multiple Regression model, Total Tenderness Score
We would like to examine the relationship between the dependent variable: Total Tenderness Score(summed score from 8 points bilateral, each point can score 0-3), and the Independent variables: Neck Pain in general(Yes/No), Migraine localisation (occipital: Yes/No), Headache Frequency(days/month), Allodynia (Yes/No), Years with Migraine(Number of years)
Time frame: 3 hours
Logistic regression model, Neck pain in general
We would like to examine the relationship between the variable variable: Neck pain in general (Yes/No) and the independent variables: Tension Type Headache(yes/no), Migraine localisation, Headache Frequency(Headache days/month), Allodynia(yes/No), Years with Migraine(number of years)
Time frame: 3 hours
Next migraine attack, Cox proportional hazards model
Using the prospective diary, we will examine the relationship between pericranial muscle tenderness and the next migraine attack, when correcting for headache frequency
Time frame: 3 hours
Correlation analysis of muscle hardness and headache frequency
Muscle hardness will be measured with ultrasound elastography. Headache frequency is self-reported
Time frame: 3 hours
Correlation analysis of muscle hardness and muscle tenderness assessed with the total tenderness score.
Muscle hardness will be measured with ultrasound elastography.
Time frame: 3 hours
Correlation analysis of muscle hardness and pressure pain threshold assessed with an pressure algometer.
Muscle hardness will be measured with ultrasound elastography
Time frame: 3 hours
Plan to share: Undecided
Ran from Aug 2017 to primary completion in Dec 2018, 16 months.
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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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