Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

Study Overview
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Brief Summary
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The aim is to establish how headache and migraine can affect muscle hardness and tenderness in migraine patients

Detailed Description
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Migraine is a very common disorder, and many migraine patients have symptoms from their neck and muscles. 50% of migraine patients have a sensation of stiff neck in relation to migraine attacks. Furthermore it is well established, that migraine patients have tender muscles during migraine attack, which can be measured with pressure pain threshold. In this study the investigators aim to establish the variation in ultrasound elastography and pressure pain threshold in migraine patients over time. And establish the significance of headache, migraine and prodromes on these measurements. The study includes daily measurements of muscle hardness and muscle tenderness. The patients are asked to fulfill a headache diary and a short questionnaire asking about current headache, physical activity, stress and current infectious diseases. Sleep and physical activity is also measured objectively using a fitbit Charge2. Furthermore the patients are asked about symptoms which often are associated with migraine (prodromes).

Official Title
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Day to Day Variation of Pressure Pain Threshold and Muscle Hardness in Migraine Patients

Conditions
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Migraine Disorders, Tenderness, Muscle, Headache Disorders

Intervention / Treatment
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* Other: Ultrasound Elastography
* Other: Pressure Pain threshold


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Migraine Patient fulfilling international classification of headache disorders (ICHD 3) criteria Exclusion Criteria: regular medication use other than medication for migraine or headache Other Pain disorders Musculoskeletal disorders affecting neck or upper body

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Migraine patients<br>Migraine patients, who do not have any other diseases except from tension type headache. No intervention, but daily measurements of muscle hardness (Ultrasound Elastography) and tenderness (Pressure pain threshold) | Other: Ultrasound Elastography<br>* Measuring muscle hardness at the trapezius and neck bilateral<br>Other: Pressure Pain threshold<br>* Measuring Pressure pain threshold at the trapezius and neck bilateral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of migraine on muscle tenderness | Muscle tenderness will be measured every day with pressure pain threshold. Migraine and headache is noted in a headache diary. Is the next measurement of muscle tenderness after migraine attack higher than those with out temporal proximity to headache. (paired T-test) | Daily measurements for about 30-60 days in a row | 
| Effect of migraine on muscle hardness | Muscle hardness will be measured every day with Ultrasound elastography. Migraine and headache is noted in a headache diary. Is the next measurement of muscle tenderness after migraine attack higher than those with out temporal proximity to headache. (paired T-test) | Daily measurements for about 30-60 days in a row | 
| Regression analysis of muscle hardness | Muscle hardness as the dependent variable and the following as the independent variables: Current migraine, Days until next migraine attack, days since last migraine attack, Sleep quality, physical activity, Stiff Neck (subjective feeling). The result shows how much of the variability in muscle hardness that can be explained by the independent variables. | Daily measurements for about 30-60 days in a row | 
| Regression analysis of muscle tenderness | Muscle tenderness as the dependent variable and the following as the independent variables: Current migraine, Days until next migraine attack, days since last migraine attack, Sleep quality, physical activity, stiff neck (subjective feeling). The result shows how much of the variability in muscle hardness that can be explained by the independent variables. | Daily measurements for about 30-60 days in a row | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Day to day variation of muscle hardness in non-headache days | Muscle hardness will be measured every day with Ultrasound elastography. Migraine and headache is noted in a headache diary. | Daily measurements for about 30-60 days in a row | 
| Day to day variation of muscle tenderness in non-headache days | Muscle tenderness will be measured every day with pressure pain threshold. Migraine and headache is noted in a headache diary. | Daily measurements for about 30-60 days in a row | 
| Prodromes in migraine patients assessed by self-reported questionnaires | Descriptive data of how often migraine patients experience prodrome like symptoms | Patients are every day asked of symptoms for the last 24 hours and current symptoms | 
| Effect of tension type headache on muscle hardness | Muscle hardness will be measured every day with Ultrasound elastography. Migraine and headache is noted in a headache diary. Is the measurements performed on headache days higher than those with out temporal proximity to headache. | Daily measurements for about 30-60 days in a row | 
| Effect of tension type headache on muscle tenderness. | Muscle tenderness will be measured every day with pressure pain threshold. Migraine and headache is noted in a headache diary. Is the measurements performed on headache days higher than those with out temporal proximity to headache. | Daily measurements for about 30-60 days in a row | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound elastography, Pressure pain threshold, variation