Muscle Tenderness and Hardness in Migraine Patients

NCT03626805 | Completed

• 1 other identifier: 001
• Study Type: observational
• Target: 146
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Multiple Regression model, Total Tenderness Score

  3 hours

• Logistic regression model, Neck pain in general

  3 hours

• Next migraine attack, Cox proportional hazards model

  3 hours

Other Outcomes (3)

• Correlation analysis of muscle hardness and headache frequency

  3 hours

• Correlation analysis of muscle hardness and muscle tenderness assessed with the total tenderness score.

  3 hours

• Correlation analysis of muscle hardness and pressure pain threshold assessed with an pressure algometer.

  3 hours

Study Arms (2)

Migraine patients

Migraine patients attending the Danish Headache Centre

Healthy Controls

Age and sex matched

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Migraine Patients from the Danish Headache Centre. Migraine classified using the International Classification of Headache Disorders (ICHD3) criteria.

You may not qualify if:

• 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:
• Pregnant or lactating women
• Musculoskeletal injuries in the neck or shoulder
• Migraine disorders
• \. 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

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 32295400 DERIVED

MeSH Terms

Conditions

Migraine Disorders; Myalgia; Headache Disorders, Primary; Nervous System Diseases

Condition Hierarchy (Ancestors)

Headache Disorders; Brain Diseases; Central Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeppe H Mann, MD

  Danish Headache Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: August 13, 2018
• Study Start: August 13, 2017
• Primary Completion: December 18, 2018
• Study Completion: December 18, 2018
• Last Updated: May 29, 2019

Record last verified: 2019-05

Locations

DK (1)