Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

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

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

Study Overview

• Status: Completed
• Conditions: Migraine Disorders; Headache Disorders; Tenderness, Muscle
• Intervention / Treatment: Other: Ultrasound Elastography; Other: Pressure Pain threshold

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 Type: Observational
• Enrollment (Actual): 3

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: N/A

• Sampling Method: Non-Probability Sample

Study Population

Migraine patients fulfilling the ICHD 3 Criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Migraine patients; 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)	Other: Ultrasound Elastography; Measuring muscle hardness at the trapezius and neck bilateral; Other: Pressure Pain threshold; Measuring Pressure pain threshold at the trapezius and neck bilateral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Danish Headache Center

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): January 15, 2019
• Study Completion (Actual): January 15, 2019

Study Registration Dates

• First Submitted: June 5, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: variation; Ultrasound elastography; Pressure pain threshold
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Musculoskeletal Pain; Headache Disorders, Primary; Myalgia; Migraine Disorders; Headache; Headache Disorders
• Other Study ID Numbers: 002 (University of CT Health Center)

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