Muscle Tenderness and Hardness in Migraine Patients

Completed

• Conditions: Headache, Migraine; Migraine Disorders; Nervous System Diseases; Muscle Tenderness; Headache Disorders, Primary

• Registration Number: NCT03626805
• Lead Sponsor: 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

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 Timeline

• Study Start: 2017-08-13
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-08-09
• Study First Posted: 2018-08-13
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-24
• Last Update Posted: 2019-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Logistic regression model, Neck Stiffness	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.
Muscle hardness measured by ultrasound elastography in migaine patients	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.
Muscle Hardness measured by ultrasound elastography	3 hours	Muscle hardness (m/s) in migraine patients compared to healthy controls.corrected for age, BMI and sex
Pericranial Muscle Tenderness	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.

Secondary Outcome Measures

Name	Time	Method
Next migraine attack, Cox proportional hazards model	3 hours	Using 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 Score	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)
Logistic regression model, Neck pain in general	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)

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark