Muscle Tenderness and Hardness in Migraine Patients

Migraine Disorders Clinical Trial

Official title:

Muscle Tenderness and Hardness in Migraine Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626805
• Other study ID #: 001
• Status: Completed
• Start date: August 13, 2017
• Est. completion date: December 18, 2018

Study information

• Verified date: May 2019
• Source: Danish Headache Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: December 18, 2018
• Est. primary completion date: December 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Headache
• Headache Disorders
• Headache Disorders, Primary
• Headache, Migraine
• Migraine Disorders
• Muscle Tenderness
• Myalgia
• Nervous System Diseases

Locations

Country	Name	City	State
Denmark	Danish Headache Center	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome

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