- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Bernhard Taxer, PhD
- Telefonnummer: +436508108217
- E-post: b.taxer@crcs.at
Studieorter
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Salzburg, Österrike, 5020
- Universitätsklinik für Neurologie, neurologische Intensivmedizin und Neurorehabilitation
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Kontakt:
- Bernhard Taxer, PhD
- Telefonnummer: +436508108217
- E-post: b.taxer@crcs.at
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Pressure Pain Algometry and neurodynamic testing for mechanical hypersensitivity
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Stefan Leis, PD Dr.med., Paracelsus Medical University for Neurology - Christian-Doppler-Klinik Salzburg
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1063/2026 Migraine_MechSens
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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