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Completed

NCT Number: NCT03632928

Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

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

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Key information

Conditions

Migraine Disorders Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Tenderness, Muscle

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Headache Center

Glostrup Municipality, 2600, Denmark

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound Elastography

Other

Measuring muscle hardness at the trapezius and neck bilateral

Pressure Pain threshold

Other

Measuring Pressure pain threshold at the trapezius and neck bilateral

Primary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. 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

  1. Day to day variation of muscle hardness in non-headache days

    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.

  2. Day to day variation of muscle tenderness in non-headache days

    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.

  3. Prodromes in migraine patients assessed by self-reported questionnaires

    Time frame: Patients are every day asked of symptoms for the last 24 hours and current symptoms

    Descriptive data of how often migraine patients experience prodrome like symptoms

  4. Effect of tension type headache 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 measurements performed on headache days higher than those with out temporal proximity to headache.

  5. Effect of tension type headache 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 measurements performed on headache days higher than those with out temporal proximity to headache.

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 16, 2018
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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