- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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. (MechSens_Migra)
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Bernhard Taxer, PhD
- Phone Number: +436508108217
- Email: b.taxer@crcs.at
Study Locations
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Salzburg, Austria, 5020
- Universitätsklinik für Neurologie, neurologische Intensivmedizin und Neurorehabilitation
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Contact:
- Bernhard Taxer, PhD
- Phone Number: +436508108217
- Email: b.taxer@crcs.at
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stefan Leis, PD Dr.med., Paracelsus Medical University for Neurology - Christian-Doppler-Klinik Salzburg
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1063/2026 Migraine_MechSens
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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