Muscle Tenderness and Hardness in Migraine Patients
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|ClinicalTrials.gov Identifier: NCT03626805|
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 15, 2018
|Condition or disease|
|Migraine Disorders Muscle Tenderness Headache Disorders, Primary Nervous System Diseases Headache, Migraine|
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
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Muscle Tenderness and Hardness in Migraine Patients|
|Actual Study Start Date :||August 13, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Migraine patients attending the Danish Headache Centre
Age and sex matched
- Logistic regression model, Neck Stiffness [ Time Frame: 3 hours ]
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.
- Muscle Hardness measured by ultrasound elastography [ Time Frame: 3 hours ]Muscle hardness (m/s) in migraine patients compared to healthy controls.corrected for age, BMI and sex
- Multiple Regression model, Total Tenderness Score [ Time Frame: 3 hours ]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)
- Logistic regression model, Neck pain in general [ Time Frame: 3 hours ]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)
- Correlation analysis of muscle hardness and headache frequency [ Time Frame: 3 hours ]Muscle hardness will be measured with ultrasound elastography. Headache frequency is self-reported
- Correlation analysis of muscle hardness and muscle tenderness assessed with the total tenderness score. [ Time Frame: 3 hours ]Muscle hardness will be measured with ultrasound elastography.
- Correlation analysis of muscle hardness and pressure pain threshold assessed with an pressure algometer. [ Time Frame: 3 hours ]Muscle hardness will be measured with ultrasound elastography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626805
|Contact: Jeppe H Mann, MD||+45 firstname.lastname@example.org|
|Contact: Henrik W Schytz, MD, PhDemail@example.com|
|Danish Headache Center||Recruiting|
|Glostrup, Denmark, 2600|
|Contact: Jeppe H Mann, MD +45 26642684 Jeppe.firstname.lastname@example.org|
|Principal Investigator:||Jeppe H Mann, MD||Danish Headache Center|