Migraine DisordersNCT03626805
Muscle Tenderness and Hardness in Migraine Patients
An observational study of Migraine Disorders and Muscle Tenderness, run by Danish Headache Center at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine Disorders, Muscle Tenderness, Headache Disorders, Primary
- How many people
- 146 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Aug 2017to 18 Dec 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Migraine patients are recruited from the out-patient clinic at the Danish Headache Center. Healthy controls are recruited through web-sites.
Who may be able to join
- Migraine Patients from the Danish Headache Centre. Migraine classified using the International Classification of Headache Disorders (ICHD3) criteria.
Who cannot join
- 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
Show all 14Show fewer
- Healthy controls:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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
- Conditions
- Migraine Disorders, Muscle Tenderness, Headache Disorders, Primary, Nervous System Diseases, Headache, Migraine
- Medical subject headings
- Migraine Disorders, Myalgia, Headache Disorders, Primary, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Migraine patients | Migraine patients attending the Danish Headache Centre | |
| Healthy Controls | Age and sex matched |
What is being measured
The primary outcome is the main question the study is designed to answer.
Logistic regression model, Neck Stiffness
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.
Measured: 3 hours
Pericranial Muscle Tenderness
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.
Measured: 3 hours
Muscle Hardness measured by ultrasound elastography
Muscle hardness (m/s) in migraine patients compared to healthy controls.corrected for age, BMI and sex
Measured: 3 hours
Muscle hardness measured by ultrasound elastography in migaine patients
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.
Measured: 3 hours
Secondary outcomes (3)
Multiple Regression model, Total Tenderness Score
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)
Measured: 3 hours
Logistic regression model, Neck pain in general
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)
Measured: 3 hours
Next migraine attack, Cox proportional hazards model
Using the prospective diary, we will examine the relationship between pericranial muscle tenderness and the next migraine attack, when correcting for headache frequency
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start13 Aug 2017
- Primary completion18 Dec 2018
- Study completion18 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 146 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
- Investigators
- Jeppe H Mann, MD, Principal investigator, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626805
- Sponsor's protocol ID
- 001
- Status last verified
- May 2019
- First submitted
- 5 Jun 2018
- Last updated
- 29 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hvedstrup J, Kolding LT, Ashina M, Schytz HW. Increased neck muscle stiffness in migraine patients with ictal neck pain: A shear wave elastography study. Cephalalgia. 2020 May;40(6):565-574. doi: 10.1177/0333102420919998. Epub 2020 Apr 15.
PubMed 32295400
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Tenderness and Hardness in Migraine Patients
- ClinicalTrials.gov ID
- NCT03626805
- Acronym / sponsor ID
- 001
- Conditions
- Migraine Disorders, Muscle Tenderness, Headache Disorders, Primary, Nervous System Diseases, Headache, Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 13 Aug 2017 (actual)
- Primary completion
- 18 Dec 2018 (actual)
- Study completion
- 18 Dec 2018 (actual)
- First posted
- 13 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 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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Migraine patients | – | –Migraine patients attending the Danish Headache Centre |
| Healthy Controls | – | –Age and sex matched |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Migraine patients are recruited from the out-patient clinic at the Danish Headache Center. Healthy controls are recruited through web-sites.
Key inclusion criteria (1 listed)
- Migraine Patients from the Danish Headache Centre. Migraine classified using the International Classification of Headache Disorders (ICHD3) criteria.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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
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.
3 secondary outcomes
Multiple Regression model, Total Tenderness Score
Time frame: 3 hours
Logistic regression model, Neck pain in general
Time frame: 3 hours
Next migraine attack, Cox proportional hazards model
Time frame: 3 hours
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 29 May 2019.
- Derived from this study: PubMed 32295400Hvedstrup J, Kolding LT, Ashina M, Schytz HW. Increased neck muscle stiffness in migraine patients with ictal neck pain: A shear wave elastography study. Cephalalgia. 2020 May;40(6):565-574. doi: 10.1177/0333102420919998. Epub 2020 Apr 15.
- Individual participant dataSharing planned: Undecided
Related trials for Migraine Disorders
RecruitingObservational study
Study of the Glymphatic System in Migraine
Migraine
Active, not recruiting
Clinical and Neurophysiological Effects of tDCS to Visual and Motor Cortex in Migraine
Migraine
Active, not recruiting
App-Based Migraine Treatment: The Health enSuite Study
Migraine, Migraine With Aura
Not yet recruiting
A Prospective Study of Rimegepant for Short-term Preventive Treatment of Night-shift-related Migraine in Healthcare Professionals
Migraine Disorders
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
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.
Jeppe H Mann, MD principal investigator
Danish Headache Center
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 Muscle Tenderness, 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 14 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 29 May 2019. 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?
Logistic regression model, Neck Stiffness (time frame: 3 hours). 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?
On the ClinicalTrials.gov record for NCT03626805, which also lists 1 linked publication.
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 29 May 2019.