Muscle Tenderness and Hardness in Migraine Patients

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

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 146

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Danish Headache Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Migraine patients are recruited from the out-patient clinic at the Danish Headache Center.

Healthy controls are recruited through web-sites.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Migraine patients; Migraine patients attending the Danish Headache Centre
Healthy Controls; Age and sex matched

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	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.	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	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	3 hours

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation analysis of muscle hardness and headache frequency	Muscle hardness will be measured with ultrasound elastography. Headache frequency is self-reported	3 hours
Correlation analysis of muscle hardness and muscle tenderness assessed with the total tenderness score.	Muscle hardness will be measured with ultrasound elastography.	3 hours
Correlation analysis of muscle hardness and pressure pain threshold assessed with an pressure algometer.	Muscle hardness will be measured with ultrasound elastography	3 hours

Collaborators and Investigators

• Sponsor: Danish Headache Center
• Investigators: Principal Investigator: Jeppe H Mann, MD, Danish Headache Center

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2017
• Primary Completion (Actual): December 18, 2018
• Study Completion (Actual): December 18, 2018

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 29, 2019
• Last Update Submitted That Met QC Criteria: May 24, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Myalgia; Disease; Nervous System Diseases; Migraine Disorders; Headache; Headache Disorders; Headache Disorders, Primary
• Other Study ID Numbers: 001 (NavyGHB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No