Migraine DisordersNCT03632928
Day to Day Variation of Pressure Pain Threshold and Muscle Hardness
An observational study of Migraine Disorders and Tenderness, Muscle, run by Danish Headache Center at 1 site in Denmark.
Trial summary
The aim is to establish how headache and migraine can affect muscle hardness and tenderness in migraine patients Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Disorders, Tenderness, Muscle, Headache Disorders
- What is being tested?
- Ultrasound Elastography and Pressure Pain threshold
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2018to 15 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: Migraine patients fulfilling the ICHD 3 Criteria.
Who may be able to join
- Migraine Patient fulfilling international classification of headache disorders (ICHD 3) criteria
Who cannot join
- regular medication use other than medication for migraine or headache
- Other Pain disorders
- Musculoskeletal disorders affecting neck or upper body
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Day to Day Variation of Pressure Pain Threshold and Muscle Hardness in Migraine Patients
The aim is to establish how headache and migraine can affect muscle hardness and tenderness in migraine patients
Read the 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).
- Conditions
- Migraine Disorders, Tenderness, Muscle, Headache Disorders
- Being tested
- Ultrasound Elastography, Pressure Pain threshold
- Keywords
- Ultrasound elastography, Pressure pain threshold, variation
- Medical subject headings
- Migraine Disorders, Myalgia, Headache Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound ElastographyOther
Measuring muscle hardness at the trapezius and neck bilateral
Pressure Pain thresholdOther
Measuring Pressure pain threshold at the trapezius and neck bilateral
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Other: Ultrasound Elastography; Other: Pressure Pain threshold |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of migraine on muscle tenderness
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)
Measured: Daily measurements for about 30-60 days in a row
Effect of migraine on muscle hardness
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)
Measured: Daily measurements for about 30-60 days in a row
Regression analysis of muscle hardness
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.
Measured: Daily measurements for about 30-60 days in a row
Regression analysis of muscle tenderness
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.
Measured: Daily measurements for about 30-60 days in a row
Secondary outcomes (5)
Day to day variation of muscle hardness in non-headache days
Muscle hardness will be measured every day with Ultrasound elastography. Migraine and headache is noted in a headache diary.
Measured: Daily measurements for about 30-60 days in a row
Day to day variation of muscle tenderness in non-headache days
Muscle tenderness will be measured every day with pressure pain threshold. Migraine and headache is noted in a headache diary.
Measured: Daily measurements for about 30-60 days in a row
Prodromes in migraine patients assessed by self-reported questionnaires
Descriptive data of how often migraine patients experience prodrome like symptoms
Measured: Patients are every day asked of symptoms for the last 24 hours and current symptoms
Effect of tension type headache on muscle hardness
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.
Measured: Daily measurements for about 30-60 days in a row
Effect of tension type headache on muscle tenderness.
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.
Measured: Daily measurements for about 30-60 days in a row
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Sep 2018
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeppe Hvedstrup Mann, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632928
- Sponsor's protocol ID
- 002
- Status last verified
- Aug 2024
- First submitted
- 5 Jun 2018
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Day to Day Variation of Pressure Pain Threshold and Muscle Hardness in Migraine Patients
- ClinicalTrials.gov ID
- NCT03632928
- Acronym / sponsor ID
- 002
- Conditions
- Migraine Disorders, Tenderness, Muscle, Headache Disorders
- Keywords
- Ultrasound elastography, Pressure pain threshold, variation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 16 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Migraine patients | – | Other: Ultrasound Elastography, Other: Pressure Pain thresholdMigraine 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Migraine patients fulfilling the ICHD 3 Criteria.
Key inclusion criteria (1 listed)
- Migraine Patient fulfilling international classification of headache disorders (ICHD 3) criteria
Key exclusion criteria (3 listed)
- regular medication use other than medication for migraine or headache
- Other Pain disorders
- Musculoskeletal disorders affecting neck or upper body
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound ElastographyMeasuring muscle hardness at the trapezius and neck bilateral | Other | Migraine patients |
| Pressure Pain thresholdMeasuring Pressure pain threshold at the trapezius and neck bilateral | Other | Migraine patients |
Primary outcome
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)
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)
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.
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.
5 secondary outcomes
Day to day variation of muscle hardness in non-headache days
Time frame: Daily measurements for about 30-60 days in a row
Day to day variation of muscle tenderness in non-headache days
Time frame: Daily measurements for about 30-60 days in a row
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
Effect of tension type headache on muscle hardness
Time frame: Daily measurements for about 30-60 days in a row
Effect of tension type headache on muscle tenderness.
Time frame: Daily measurements for about 30-60 days in a row
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine Disorders and Tenderness, Muscle, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of migraine on muscle tenderness (time frame: Daily measurements for about 30-60 days in a row). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2024.