Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

Completed

• Conditions: Headache Disorders; Migraine Disorders; Tenderness, Muscle
• Interventions: Other: Ultrasound Elastography; Other: Pressure Pain threshold

• Registration Number: NCT03632928
• Lead Sponsor: Danish Headache Center

Brief Summary

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

Detailed 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).

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Study Start: 2018-09-01
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Migraine patients	Pressure Pain threshold	Migraine patients, who do not have any other diseases except from tension type headache. No intervention, but daily measurements of muscle hardness (Ultrasound Elastography) and tenderness (Pressure pain threshold)
Migraine patients	Ultrasound Elastography	Migraine patients, who do not have any other diseases except from tension type headache. No intervention, but daily measurements of muscle hardness (Ultrasound Elastography) and tenderness (Pressure pain threshold)

Primary Outcome Measures

Name	Time	Method
Effect of migraine on muscle tenderness	Daily measurements for about 30-60 days in a row	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)
Effect of migraine on muscle hardness	Daily measurements for about 30-60 days in a row	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)
Regression analysis of muscle hardness	Daily measurements for about 30-60 days in a row	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.
Regression analysis of muscle tenderness	Daily measurements for about 30-60 days in a row	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.

Secondary Outcome Measures

Name	Time	Method
Prodromes in migraine patients assessed by self-reported questionnaires	Patients are every day asked of symptoms for the last 24 hours and current symptoms	Descriptive data of how often migraine patients experience prodrome like symptoms
Day to day variation of muscle tenderness in non-headache days	Daily measurements for about 30-60 days in a row	Muscle tenderness will be measured every day with pressure pain threshold. Migraine and headache is noted in a headache diary.
Day to day variation of muscle hardness in non-headache days	Daily measurements for about 30-60 days in a row	Muscle hardness will be measured every day with Ultrasound elastography. Migraine and headache is noted in a headache diary.
Effect of tension type headache on muscle hardness	Daily measurements for about 30-60 days in a row	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.
Effect of tension type headache on muscle tenderness.	Daily measurements for about 30-60 days in a row	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.

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark