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Trial record 10 of 834 for:    Migraine AND Headache Disorders

Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

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ClinicalTrials.gov Identifier: NCT03632928
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Sponsor:
Information provided by (Responsible Party):
Jeppe Hvedstrup Mann, Danish Headache Center

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

Condition or disease Intervention/treatment
Migraine Disorders Tenderness, Muscle Headache Disorders Other: Ultrasound Elastography Other: Pressure Pain threshold

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).


Study Type : Observational
Estimated Enrollment : 3 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Day to Day Variation of Pressure Pain Threshold and Muscle Hardness in Migraine Patients
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Group/Cohort Intervention/treatment
Migraine patients

Migraine patients, who do not have any other diseases except from tension type headache.

No intervention, but daily measurements of muscle hardness (Ultrasound Elastography) and tenderness (Pressure pain threshold)

Other: Ultrasound Elastography
Measuring muscle hardness at the trapezius and neck bilateral

Other: Pressure Pain threshold
Measuring Pressure pain threshold at the trapezius and neck bilateral




Primary Outcome Measures :
  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 Outcome Measures :
  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.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Migraine patients fulfilling the ICHD 3 Criteria.
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

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): NCT03632928


Contacts
Contact: Jeppe H Mann, MD +4538632684 jeppe.hvedstrup.mann@regionh.dk
Contact: Henrik W Schytz, MD, PhD henrik.winther.schytz.01@regionh.dk

Locations
Denmark
Danish Headache Center
Glostrup, Denmark, 2600
Sponsors and Collaborators
Danish Headache Center

Responsible Party: Jeppe Hvedstrup Mann, MD., Clinical assistant, PhD Student, Danish Headache Center
ClinicalTrials.gov Identifier: NCT03632928     History of Changes
Other Study ID Numbers: 002
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 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

Keywords provided by Jeppe Hvedstrup Mann, Danish Headache Center:
Ultrasound elastography
Pressure pain threshold
variation

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