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. (MechSens_Migra)

April 24, 2026 updated by: Bernhard Taxer

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Bernhard Taxer, PhD
  • Phone Number: +436508108217
  • Email: b.taxer@crcs.at

Study Locations

      • Salzburg, Austria, 5020
        • Universitätsklinik für Neurologie, neurologische Intensivmedizin und Neurorehabilitation
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

patients with episodic or chronic migraine

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Stefan Leis, PD Dr.med., Paracelsus Medical University for Neurology - Christian-Doppler-Klinik Salzburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

November 30, 2026

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 24, 2026

First Posted (Actual)

April 30, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 24, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1063/2026 Migraine_MechSens

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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