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.

NCT07559565 | Not Yet Recruiting

• 1 other identifier: 1063/2026 Migraine_MechSens
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine

Outcome Measures

Primary Outcomes (1)

• Pressure Pain Algometry and neurodynamic testing for mechanical hypersensitivity

  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.

  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.

Interventions

pressure pain algometry DIAGNOSTIC_TEST

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.

Eligibility Criteria

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

Study Population

patients with episodic or chronic migraine

You may qualify if:

• Female and male sex
• Age 18-65 years
• Diagnosis of episodic or chronic migraine according to ICHD-3 criteria (beta version)
• Ability to understand study procedures and provide written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bernhard Taxer: lead

Study Sites (1)

Universitätsklinik für Neurologie, neurologische Intensivmedizin und Neurorehabilitation

Salzburg, 5020, Austria

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Stefan Leis, PD Dr.med.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bernhard Taxer, PhD

CONTACT

+436508108217; b.taxer@crcs.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific collaborator

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 30, 2026
• Study Start: June 1, 2026
• Primary Completion: September 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)