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Not yet recruiting NCT07559565

Migraine is Associated With Altered Mechanical Pain Sensitivity. This Study Investigates Mechanical Pain Sensitivity, Headache Burden, and Quality of Life in Episodic and Chronic Migraine, Comparing Pressure Algometry and Algopeg® and Assessing Mechanosensitivity of Peripheral Nerves.

Observational Migraine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: pressure pain algometry.
Who it may be relevant to
Registry conditions: Migraine. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Mechanical Pain Sensitivity, Headache Burden, and Quality of Life in Episodic and Chronic Migraine - A Cross-Sectional Study

Overview

Migraine is one of the most prevalent neurological disorders and is associated with a substantial individual and societal burden. In chronic migraine, central and peripheral sensitization mechanisms are considered key pathophysiological factors and may manifest, among other features, as altered mechanical pain sensitivity. Quantitative assessment of mechanical pain sensitivity using pressure algometry is an established method; however, it is partly dependent on examiner technique and measurement protocols. The Algopeg® represents a standardized instrument for assessing mechanical pain sensitivity and may serve as a practical complement or alternative to classical pressure algometry. To date, evidence regarding the use of the Algopeg® in migraine populations remains limited. In addition to increased mechanosensitivity in trigeminal and extra-trigeminal regions, peripheral nerve structures, such as branches of the greater occipital nerve and the supraorbital nerve, may show sensitivity to mechanical stimuli during neurodynamic testing or palpation. This may have clinical relevance, as these regions are often targeted in symptomatic and prophylactic treatments. The aim of this study is to systematically investigate mechanical pain sensitivity, headache-related outcomes, and quality of life in patients with episodic and chronic migraine. Furthermore, the study aims to compare pressure algometry and Algopeg® measurements and to explore the clinical relevance of mechanosensitivity in specific peripheral nerve regions using a standardized assessment protocol.

Interventions

  • Diagnostic test pressure pain algometry
    Pressure pain algometry will be compared with an alternative tool to evaluate a potentially faster and more cost-effective method for assessing mechanical hypersensitivity in migraine. Furthermore, neurodynamic tests targeting mechanosensitivity of neural soft tissues will be examined with regard to their validity in primary headache disorders.

Primary outcome measures

  • Pressure Pain Algometry and neurodynamic testing for mechanical hypersensitivity [Time frame: Regarding the observational character of the study the participants are screened in one session expecting a total time frame of 15 minutes on day 1.]

Eligibility criteria

Inclusion criteria

  • Female and male sex
  • Age 18-65 years
  • Diagnosis of episodic or chronic migraine according to ICHD-3 criteria (beta version)
  • Stable medication regimen (if applicable) for at least 4 weeks prior to inclusion
  • Ability to understand study procedures and provide written informed consent

Exclusion criteria

  • Other primary or secondary headache disorders
  • Severe neurological, psychiatric, or systemic diseases
  • Pregnancy or breastfeeding
  • Participation in another (interventional) study within the last 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Austria · 1 center
  • Universitätsklinik für Neurologie, neurologische Intensivmedizin und Neurorehabilitation — Salzburg

Identifiers

NCT: NCT07559565 · 1063/2026 Migraine_MechSens

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗