Clinical trial NCT03632928: Day to Day Variation of Pressure Pain Threshold and Muscle Hardness
Official title: Day to Day Variation of Pressure Pain Threshold and Muscle Hardness in Migraine Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine Disorders
Tenderness, Muscle
Headache Disorders
Keywords: Ultrasound elastography
Pressure pain threshold
variation
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Migraine patients fulfilling the ICHD 3 Criteria.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Effect of migraine on muscle tenderness
timeFrame: Daily measurements for about 30-60 days in a row
measure: Effect of migraine on muscle hardness
timeFrame: Daily measurements for about 30-60 days in a row
measure: Regression analysis of muscle hardness
timeFrame: Daily measurements for about 30-60 days in a row
measure: Regression analysis of muscle tenderness
timeFrame: Daily measurements for about 30-60 days in a row
Secondary outcomes:
measure: Day to day variation of muscle hardness in non-headache days
timeFrame: Daily measurements for about 30-60 days in a row
measure: Day to day variation of muscle tenderness in non-headache days
timeFrame: Daily measurements for about 30-60 days in a row
measure: Prodromes in migraine patients assessed by self-reported questionnaires
timeFrame: Patients are every day asked of symptoms for the last 24 hours and current symptoms
measure: Effect of tension type headache on muscle hardness
timeFrame: Daily measurements for about 30-60 days in a row
measure: Effect of tension type headache on muscle tenderness.
timeFrame: Daily measurements for about 30-60 days in a row
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Danish Headache Center
Study officials:
References: