Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

Migraine Disorders Clinical Trial

Official title:

Day to Day Variation of Pressure Pain Threshold and Muscle Hardness in Migraine Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03632928
• Other study ID #: 002
• Status: Not yet recruiting
• Start date: September 2018
• Est. completion date: March 2019

Study information

• Verified date: August 2018
• Source: Danish Headache Center
• Contact: Jeppe H Mann, MD
• Phone: +4538632684
• Email: jeppe.hvedstrup.mann[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim is to establish how headache and migraine can affect muscle hardness and tenderness in migraine patients

Description:

Migraine is a very common disorder, and many migraine patients have symptoms from their neck and muscles. 50% of migraine patients have a sensation of stiff neck in relation to migraine attacks. Furthermore it is well established, that migraine patients have tender muscles during migraine attack, which can be measured with pressure pain threshold.

In this study the investigators aim to establish the variation in ultrasound elastography and pressure pain threshold in migraine patients over time. And establish the significance of headache, migraine and prodromes on these measurements.

The study includes daily measurements of muscle hardness and muscle tenderness. The patients are asked to fulfill a headache diary and a short questionnaire asking about current headache, physical activity, stress and current infectious diseases. Sleep and physical activity is also measured objectively using a fitbit Charge2. Furthermore the patients are asked about symptoms which often are associated with migraine (prodromes).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3
• Est. completion date: March 2019
• Est. primary completion date: January 2019
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Migraine Patient fulfilling international classification of headache disorders (ICHD 3) criteria

Exclusion Criteria:

• regular medication use other than medication for migraine or headache

• Other Pain disorders

• Musculoskeletal disorders affecting neck or upper body

Related Conditions & MeSH terms

• Disease
• Headache
• Headache Disorders
• Migraine Disorders
• Myalgia
• Tenderness, Muscle

Intervention

Other:
• Ultrasound Elastography
Measuring muscle hardness at the trapezius and neck bilateral
• Pressure Pain threshold
Measuring Pressure pain threshold at the trapezius and neck bilateral

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
Primary	Effect of migraine on muscle tenderness	Muscle tenderness will be measured every day with pressure pain threshold. Migraine and headache is noted in a headache diary.; Is the next measurement of muscle tenderness after migraine attack higher than those with out temporal proximity to headache. (paired T-test)	Daily measurements for about 30-60 days in a row
Primary	Effect of migraine on muscle hardness	Muscle hardness will be measured every day with Ultrasound elastography. Migraine and headache is noted in a headache diary.; Is the next measurement of muscle tenderness after migraine attack higher than those with out temporal proximity to headache. (paired T-test)	Daily measurements for about 30-60 days in a row
Primary	Regression analysis of muscle hardness	Muscle hardness as the dependent variable and the following as the independent variables: Current migraine, Days until next migraine attack, days since last migraine attack, Sleep quality, physical activity, Stiff Neck (subjective feeling).; The result shows how much of the variability in muscle hardness that can be explained by the independent variables.	Daily measurements for about 30-60 days in a row
Primary	Regression analysis of muscle tenderness	Muscle tenderness as the dependent variable and the following as the independent variables: Current migraine, Days until next migraine attack, days since last migraine attack, Sleep quality, physical activity, stiff neck (subjective feeling).; The result shows how much of the variability in muscle hardness that can be explained by the independent variables.	Daily measurements for about 30-60 days in a row
Secondary	Day to day variation of muscle hardness in non-headache days	Muscle hardness will be measured every day with Ultrasound elastography. Migraine and headache is noted in a headache diary.	Daily measurements for about 30-60 days in a row
Secondary	Day to day variation of muscle tenderness in non-headache days	Muscle tenderness will be measured every day with pressure pain threshold. Migraine and headache is noted in a headache diary.	Daily measurements for about 30-60 days in a row
Secondary	Prodromes in migraine patients assessed by self-reported questionnaires	Descriptive data of how often migraine patients experience prodrome like symptoms	Patients are every day asked of symptoms for the last 24 hours and current symptoms
Secondary	Effect of tension type headache on muscle hardness	Muscle hardness will be measured every day with Ultrasound elastography. Migraine and headache is noted in a headache diary.; Is the measurements performed on headache days higher than those with out temporal proximity to headache.	Daily measurements for about 30-60 days in a row
Secondary	Effect of tension type headache on muscle tenderness.	Muscle tenderness will be measured every day with pressure pain threshold. Migraine and headache is noted in a headache diary.; Is the measurements performed on headache days higher than those with out temporal proximity to headache.	Daily measurements for about 30-60 days in a row