MigraineMechSens_MigraNCT07559565
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.
An observational study of Migraine, run by Bernhard Taxer at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- pressure pain algometry
- How many people
- 102 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jun 2026to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with episodic or chronic migraine
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site
Universitätsklinik für Neurologie, neurologische Intensivmedizin und Neurorehabilitation
Salzburg, 5020
Bernhard Taxer, PhD, +436508108217, b.taxer@crcs.at
About this study
Official title: 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.
Read more
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
- Being tested
- pressure pain algometry
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pressure pain algometryDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bernhard Taxer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bernhard Taxer, Paracelsus Medical University
- Investigators
- Stefan Leis, PD Dr.med., Principal investigator, Paracelsus Medical University for Neurology - Christian-Doppler-Klinik Salzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559565
- Sponsor's protocol ID
- 1063/2026 Migraine_MechSens
- Acronym
- MechSens_Migra
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Pain Sensitivity, Headache Burden, and Quality of Life in Episodic and Chronic Migraine - A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07559565
- Acronym / sponsor ID
- MechSens_Migra / 1063/2026 Migraine_MechSens
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Bernhard TaxerUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with episodic or chronic migraine
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pressure pain algometryPressure 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. | Diagnostic test | – |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Leis, PD Dr.med. principal investigator
Paracelsus Medical University for Neurology - Christian-Doppler-Klinik Salzburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by Bernhard Taxer at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bernhard Taxer, PhD (+436508108217, b.taxer@crcs.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.