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Muscle Tenderness and Hardness in Migraine Patients

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ClinicalTrials.gov Identifier: NCT03626805
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 15, 2018
Sponsor:
Information provided by (Responsible Party):
Jeppe Hvedstrup Mann, Danish Headache Center

Brief Summary:
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

Condition or disease
Migraine Disorders Muscle Tenderness Headache Disorders, Primary Nervous System Diseases Headache, Migraine

Detailed Description:

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


Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Muscle Tenderness and Hardness in Migraine Patients
Actual Study Start Date : August 13, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Group/Cohort
Migraine patients
Migraine patients attending the Danish Headache Centre
Healthy Controls
Age and sex matched



Primary Outcome Measures :
  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. 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


Secondary Outcome Measures :
  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)


Other Outcome Measures:
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Migraine patients are recruited from the out-patient clinic at the Danish Headache Center.

Healthy controls are recruited through web-sites.

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626805


Contacts
Contact: Jeppe H Mann, MD +45 38632684 jeppe.hvedstrup.mann@regionh.dk
Contact: Henrik W Schytz, MD, PhD henrik.winther.schytz.01@regionh.dk

Locations
Denmark
Danish Headache Center Recruiting
Glostrup, Denmark, 2600
Contact: Jeppe H Mann, MD    +45 26642684    Jeppe.hvedstrup.mann@regionh.dk   
Sponsors and Collaborators
Danish Headache Center
Investigators
Principal Investigator: Jeppe H Mann, MD Danish Headache Center

Responsible Party: Jeppe Hvedstrup Mann, PhD Student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03626805     History of Changes
Other Study ID Numbers: 001
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 15, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Disease
Headache
Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Myalgia
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Neuromuscular Diseases