An observational study in Migraine Disorders, Tenderness, Muscle and Headache Disorders, sponsored by Danish Headache Center. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-14.
Sponsored by Danish Headache Center · Observational
The aim is to establish how headache and migraine can affect muscle hardness and tenderness in migraine patients
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).
1,558 studies on the registry are indexed under Migraine Disorders; 301 are open to participants now.
This study's enrollment of 3 is below the median of 130 across 306 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 fulfilling the ICHD 3 Criteria.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 · Other: Pressure Pain threshold
Measuring muscle hardness at the trapezius and neck bilateral
Measuring Pressure pain threshold at the trapezius and neck bilateral
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)
Time frame: 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)
Time frame: 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.
Time frame: 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.
Time frame: Daily measurements for about 30-60 days in a row
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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: Daily measurements for about 30-60 days in a row
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.