Muscle Tenderness and Hardness in Migraine Patients

NCT ID: NCT03626805

Last Updated: 2019-05-29

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

146 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-13

Study Completion Date

2018-12-18

Brief Summary

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

The aim of the study is to examine symptomatology, quantitative sensory test (QST) parameters, muscle tenderness and muscle hardness in migraine patients interictally and compare with healthy controls

Detailed Description

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

Migraine patients exhibit different symptomatology and responses to treatment. For example do many migraine patients have neck symptoms, despite they apparently do not have any neck disorders.Furthermore the response to treatment differs between patients. Differences in symptomatology, QST parameters and muscle stiffness can be used to subdivide and phenotype migraine patients.

The investigators are examining migraine patients with:

A semistructured interview, Quantitative sensory testing (cold pain threshold, heat pain threshold and Pin Prick), Muscle tenderness (total tenderness score, local tenderness score and stimulus response curve), and muscle hardness with ultrasound elastography. All tests are performed the same day

Conditions

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

Migraine Disorders Muscle Tenderness Headache Disorders, Primary Nervous System Diseases Headache, Migraine

Study Design

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

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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

Migraine patients

Migraine patients attending the Danish Headache Centre

No interventions assigned to this group

Healthy Controls

Age and sex matched

No interventions assigned to this group

Eligibility Criteria

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

Inclusion Criteria

* Migraine Patients from the Danish Headache Centre. Migraine classified using the International Classification of Headache Disorders (ICHD3) criteria.

Exclusion Criteria

* Pregnant or lactating women
* Musculoskeletal injuries in the neck or shoulder
* Other primary headache disorders than migraine or Tension Type Headache
* On the time of examination: Migraine free for at least 48 hours
* On the time of examination: haven't trained the upper body for at least 48 hours
* On the time of examination: haven't used painkillers for at least 48 hours

Healthy controls:


* Pregnant or lactating women
* Musculoskeletal injuries in the neck or shoulder
* Migraine disorders
* 1\. degree relatives with migraine disorders
* Over 1 day of tension type headache a month.
* On the time of examination: haven't trained the upper body for at least 48 hours
* On the time of examination: haven't used painkillers for at least 48 hours
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

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

PhD Student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jeppe H Mann, MD

Role: PRINCIPAL_INVESTIGATOR

Danish Headache Center

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

References

Explore related publications, articles, or registry entries linked to this study.

Hvedstrup J, Kolding LT, Ashina M, Schytz HW. Increased neck muscle stiffness in migraine patients with ictal neck pain: A shear wave elastography study. Cephalalgia. 2020 May;40(6):565-574. doi: 10.1177/0333102420919998. Epub 2020 Apr 15.

Reference Type DERIVED
PMID: 32295400 (View on PubMed)

Other Identifiers

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

001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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

Migraine and Body Composition
NCT01720862 COMPLETED
Migraine in Adolescents
NCT05654012 RECRUITING NA