Day to Day Variation of Pressure Pain Threshold and Muscle Hardness in Migraine Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Danish Headache Center
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Effect of migraine on muscle tenderness
Study Overview
Brief Summary
The aim is to establish how headache and migraine can affect muscle hardness and tenderness in migraine patients
Detailed Description
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Effect of migraine on muscle tenderness
Time Frame: Daily measurements for about 30-60 days in a row
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)
Effect of migraine on muscle hardness
Time Frame: Daily measurements for about 30-60 days in a row
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)
Regression analysis of muscle hardness
Time Frame: Daily measurements for about 30-60 days in a row
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.
Regression analysis of muscle tenderness
Time Frame: Daily measurements for about 30-60 days in a row
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.
Secondary Outcomes
- Prodromes in migraine patients assessed by self-reported questionnaires(Patients are every day asked of symptoms for the last 24 hours and current symptoms)
- Day to day variation of muscle tenderness in non-headache days(Daily measurements for about 30-60 days in a row)
- Day to day variation of muscle hardness in non-headache days(Daily measurements for about 30-60 days in a row)
- Effect of tension type headache on muscle hardness(Daily measurements for about 30-60 days in a row)
- Effect of tension type headache on muscle tenderness.(Daily measurements for about 30-60 days in a row)
Investigators
Jeppe Hvedstrup Mann
MD., Clinical assistant, PhD Student
Danish Headache Center