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Muscle Tenderness and Hardness in Migraine Patients

Muscle Tenderness and Hardness in Migraine Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03626805
Enrollment
146
Registered
2018-08-13
Start date
2017-08-13
Completion date
2018-12-18
Last updated
2019-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Headache Disorders, Primary, Headache, Migraine, Migraine Disorders, Muscle Tenderness, Nervous System Diseases

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

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

Interventions

None listed

Sponsors

Danish Headache Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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:

Design outcomes

Primary

MeasureTime frameDescription
Muscle Hardness measured by ultrasound elastography3 hoursMuscle hardness (m/s) in migraine patients compared to healthy controls.corrected for age, BMI and sex
Pericranial Muscle Tenderness3 hoursWe 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.
Logistic regression model, Neck Stiffness3 hoursWe 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.
Muscle hardness measured by ultrasound elastography in migaine patients3 hoursMuscle 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

MeasureTime frameDescription
Next migraine attack, Cox proportional hazards model3 hoursUsing the prospective diary, we will examine the relationship between pericranial muscle tenderness and the next migraine attack, when correcting for headache frequency
Multiple Regression model, Total Tenderness Score3 hoursWe 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)
Logistic regression model, Neck pain in general3 hoursWe 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

MeasureTime frameDescription
Correlation analysis of muscle hardness and headache frequency3 hoursMuscle hardness will be measured with ultrasound elastography. Headache frequency is self-reported
Correlation analysis of muscle hardness and pressure pain threshold assessed with an pressure algometer.3 hoursMuscle hardness will be measured with ultrasound elastography
Correlation analysis of muscle hardness and muscle tenderness assessed with the total tenderness score.3 hoursMuscle hardness will be measured with ultrasound elastography.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026