Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

NCT03632928 | Completed

• 1 other identifier: 002
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine Disorders; Tenderness, Muscle; Headache Disorders

Keywords

Ultrasound elastography; Pressure pain threshold; variation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Day to day variation of muscle hardness in non-headache days

  Daily measurements for about 30-60 days in a row

• Day to day variation of muscle tenderness in non-headache days

  Daily measurements for about 30-60 days in a row

• Prodromes in migraine patients assessed by self-reported questionnaires

  Patients are every day asked of symptoms for the last 24 hours and current symptoms

• Effect of tension type headache on muscle hardness

  Daily measurements for about 30-60 days in a row

• Effect of tension type headache on muscle tenderness.

  Daily measurements for about 30-60 days in a row

Study Arms (1)

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; Other: Pressure Pain threshold

Interventions

Ultrasound Elastography OTHER

Measuring muscle hardness at the trapezius and neck bilateral

Migraine patients

Pressure Pain threshold OTHER

Measuring Pressure pain threshold at the trapezius and neck bilateral

Migraine patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Migraine patients fulfilling the ICHD 3 Criteria.

You may qualify if:

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

You may not qualify if:

• regular medication use other than medication for migraine or headache
• Other Pain disorders
• Musculoskeletal disorders affecting neck or upper body

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Migraine Disorders; Myalgia; Headache Disorders

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD., Clinical assistant, PhD Student

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: August 16, 2018
• Study Start: September 1, 2018
• Primary Completion: January 15, 2019
• Study Completion: January 15, 2019
• Last Updated: August 14, 2024

Record last verified: 2024-08

Locations

DK (1)