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NCT Number: NCT03626805

Muscle Tenderness and Hardness in Migraine Patients

The aim of the study is to examine symptomatology, quantitative sensory test (QST) parameters, muscle tenderness and muscle hardness in migraine patients interictally and compare with healthy controls

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Key information

Conditions

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

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 patients exhibit different symptomatology and responses to treatment. For example do many migraine patients have neck symptoms, despite they apparently do not have any neck disorders.Furthermore the response to treatment differs between patients. Differences in symptomatology, QST parameters and muscle stiffness can be used to subdivide and phenotype migraine patients.

The investigators are examining migraine patients with:

A semistructured interview, Quantitative sensory testing (cold pain threshold, heat pain threshold and Pin Prick), Muscle tenderness (total tenderness score, local tenderness score and stimulus response curve), and muscle hardness with ultrasound elastography. All tests are performed the same day

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Migraine Patients from the Danish Headache Centre. Migraine classified using the International Classification of Headache Disorders (ICHD3) criteria.

Exclusion criteria

  • Pregnant or lactating women
  • Musculoskeletal injuries in the neck or shoulder
  • Other primary headache disorders than migraine or Tension Type Headache
  • On the time of examination: Migraine free for at least 48 hours
  • On the time of examination: haven't trained the upper body for at least 48 hours
  • On the time of examination: haven't used painkillers for at least 48 hours

Healthy controls:

Exclusion criteria

  • Pregnant or lactating women
  • Musculoskeletal injuries in the neck or shoulder
  • Migraine disorders
  • 1. degree relatives with migraine disorders
  • Over 1 day of tension type headache a month.
  • On the time of examination: haven't trained the upper body for at least 48 hours
  • On the time of examination: haven't used painkillers for at least 48 hours

Treatment and study plan

Primary outcomes

  1. Logistic regression model, Neck Stiffness

    Time frame: 3 hours

    We would like to examine the relationship between the variable variable: Neck stiffness during migraine attack (Yes/No) and the Independent variables: Total Tenderness Score (summed score from 8 points bilateral, each point can score 0-3), Migraine localisation (occipital: Yes/No), Tension Type Headache, Allodynia (yes/No), Stimulus response curve (Pressure and Pain).

    The result shows how much of the variability in neck stiffness that can be explained by the independent variables.

  2. Pericranial Muscle Tenderness

    Time frame: 3 hours

    We will examine whether patients with neck stiffness during migraine attack (yes/no) have higher tenderness scores compared to patients without neck stiffness during migraine attacks, when correcting for headache frequency.

  3. Muscle Hardness measured by ultrasound elastography

    Time frame: 3 hours

    Muscle hardness (m/s) in migraine patients compared to healthy controls.corrected for age, BMI and sex

  4. Muscle hardness measured by ultrasound elastography in migaine patients

    Time frame: 3 hours

    Muscle hardness (m/s) in migraine patients with neck stiffness during migraine attacks compared to migraine patients without neck stiffness during migraine attacks. Corrected for age, BMI and sex.

Secondary outcomes

  1. Multiple Regression model, Total Tenderness Score

    Time frame: 3 hours

    We would like to examine the relationship between the dependent variable: Total Tenderness Score(summed score from 8 points bilateral, each point can score 0-3), and the Independent variables: Neck Pain in general(Yes/No), Migraine localisation (occipital: Yes/No), Headache Frequency(days/month), Allodynia (Yes/No), Years with Migraine(Number of years)

  2. Logistic regression model, Neck pain in general

    Time frame: 3 hours

    We would like to examine the relationship between the variable variable: Neck pain in general (Yes/No) and the independent variables: Tension Type Headache(yes/no), Migraine localisation, Headache Frequency(Headache days/month), Allodynia(yes/No), Years with Migraine(number of years)

  3. Next migraine attack, Cox proportional hazards model

    Time frame: 3 hours

    Using the prospective diary, we will examine the relationship between pericranial muscle tenderness and the next migraine attack, when correcting for headache frequency

Other outcomes

  1. Correlation analysis of muscle hardness and headache frequency

    Time frame: 3 hours

    Muscle hardness will be measured with ultrasound elastography. Headache frequency is self-reported

  2. Correlation analysis of muscle hardness and muscle tenderness assessed with the total tenderness score.

    Time frame: 3 hours

    Muscle hardness will be measured with ultrasound elastography.

  3. Correlation analysis of muscle hardness and pressure pain threshold assessed with an pressure algometer.

    Time frame: 3 hours

    Muscle hardness will be measured with ultrasound elastography

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 13, 2018
Registry last updated
May 29, 2019

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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