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Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03632928
Enrollment
3
Registered
2018-08-16
Start date
2018-09-01
Completion date
2019-01-15
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine Disorders, Tenderness, Muscle, Headache Disorders

Keywords

Ultrasound elastography, Pressure pain threshold, variation

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).

Interventions

Measuring muscle hardness at the trapezius and neck bilateral

Measuring Pressure pain threshold at the trapezius and neck bilateral

Sponsors

Danish Headache Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Effect of migraine on muscle tendernessDaily measurements for about 30-60 days in a rowMuscle 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 hardnessDaily measurements for about 30-60 days in a rowMuscle 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 hardnessDaily measurements for about 30-60 days in a rowMuscle 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 tendernessDaily measurements for about 30-60 days in a rowMuscle 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

MeasureTime frameDescription
Day to day variation of muscle hardness in non-headache daysDaily measurements for about 30-60 days in a rowMuscle hardness will be measured every day with Ultrasound elastography. Migraine and headache is noted in a headache diary.
Effect of tension type headache on muscle tenderness.Daily measurements for about 30-60 days in a rowMuscle 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.
Day to day variation of muscle tenderness in non-headache daysDaily measurements for about 30-60 days in a rowMuscle tenderness will be measured every day with pressure pain threshold. Migraine and headache is noted in a headache diary.
Prodromes in migraine patients assessed by self-reported questionnairesPatients are every day asked of symptoms for the last 24 hours and current symptomsDescriptive data of how often migraine patients experience prodrome like symptoms
Effect of tension type headache on muscle hardnessDaily measurements for about 30-60 days in a rowMuscle 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.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026