Day to Day Variation of Pressure Pain Threshold and Muscle Hardness

NCT ID: NCT03632928

Last Updated: 2024-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Migraine Disorders Tenderness, Muscle Headache Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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)

Ultrasound Elastography

Intervention Type OTHER

Measuring muscle hardness at the trapezius and neck bilateral

Pressure Pain threshold

Intervention Type OTHER

Measuring Pressure pain threshold at the trapezius and neck bilateral

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound Elastography

Measuring muscle hardness at the trapezius and neck bilateral

Intervention Type OTHER

Pressure Pain threshold

Measuring Pressure pain threshold at the trapezius and neck bilateral

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Danish Headache Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jeppe Hvedstrup Mann

MD., Clinical assistant, PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Danish Headache Center

Glostrup Municipality, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Nutrition for Migraine Prevention
NCT02012790 COMPLETED NA
Migraine and CVD Risk in Women
NCT03081390 ACTIVE_NOT_RECRUITING NA
Migraine and Body Composition
NCT01720862 COMPLETED