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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.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07559565
Acronym
MechSens_Migra
Enrollment
102
Registered
2026-04-30
Start date
2026-06-01
Completion date
2026-11-30
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Migraine

Brief summary

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_TESTpressure 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.

Sponsors

Bernhard Taxer
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Pressure Pain Algometry and neurodynamic testing for mechanical hypersensitivityRegarding the observational character of the study the participants are screened in one session expecting a total time frame of 15 minutes on day 1.Pressure pain algometry, a psychophysic approach used in quantitatitve sensory testing, is a tool, that can be used to evaluate mechanosensitivity of affected muscles (pressure pain threshold - measured in kg). We use the classical tool out of QST and compare it with the Algopeg® tool, a calibrated clothespin, not used in regular clinical work so far. The tool is applied on the index finger for 10 seconds measuring the resulting painful feeling on a numeric rating scale (NRS 0-10). Neurodynamic testing includes movement maneuvers to assess the mechanosensitivity of the soft tissue of peripheral nerves, explicitly greater occipital nerve and the supraorbital nerve (V1). Here the outcome mainly relies on the feedback of the participants.

Countries

Austria

Contacts

CONTACTBernhard Taxer, PhD
b.taxer@crcs.at+436508108217
PRINCIPAL_INVESTIGATORStefan Leis, PD Dr.med.

Paracelsus Medical University for Neurology - Christian-Doppler-Klinik Salzburg

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026