- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06323720
Tecken på central sensibilisering vid spänningshuvudvärk (CSTTH)
Finns tecken på central sensibilisering vid spänningshuvudvärk?
The goal of this observational study is to assess the pain sensitivity in tension-type headache patients. The main question it aims to answer is:
- Are signs of central sensitization present in tension-type headache?
Participants will be asked to fill out baseline questionnaires and they will be assessed during 1 test moment (static and dynamic quantitative sensory testing).
Researchers will compare tension-type headache patients with healthy controls to see if signs of central sensitization are only present in the tension-type headache group.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
East-Flanders
-
Ghent, East-Flanders, Belgien, 9000
- Ghent University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
This study will involve participation from various populations, specifically patients with episodic tension headache, patients with chronic tension headache, and healthy pain-free controls.
Beskrivning
Inclusion Criteria:
- Diagnosis of tension headache according to globally recognized criteria (ICHD-3) or verified by a physician
- Diagnosis of tension headache confirmed by a questionnaire (Headache Screening Questionnaire)
- Not pregnant or given birth in the past year since a change in hormone levels can affect pain experience
- Adults between the ages of 18 and 65
- Proficient in the Dutch language
Exclusion Criteria:
- Other diagnosis of headache or a mixed form
- Other existing condition involving central nervous system sensitivity
- Other structural neurological syndromes
- Any condition involving the brain in the past
- Procedure on the head, neck, or shoulder in the past 3 years
- Currently suffering from a psychiatric condition
- Athletes competing at a competitive level
- Not proficient in the Dutch language
- Currently pregnant.
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: CROSS_SECTIONAL
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Episodic tension-type headache
Patients with 1 - 14 days of TTH/month. |
Assessment of the heat and cold pain thresholds, temporal summation, conditioned pain modulation, pressure pain thresholds, electrical pain thresholds, and withdrawal reflex. |
|
Chronic tension-type headache
Patients with more than 14 days TTH/month |
Assessment of the heat and cold pain thresholds, temporal summation, conditioned pain modulation, pressure pain thresholds, electrical pain thresholds, and withdrawal reflex. |
|
Healthy controls
Participants without tension-type headache |
Assessment of the heat and cold pain thresholds, temporal summation, conditioned pain modulation, pressure pain thresholds, electrical pain thresholds, and withdrawal reflex. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain sensitivity for heat stimuli
Tidsram: Baseline
|
Hypersensitivity for heat pain. The heat stimulus will be delivered with the TSA-2, using a thermode. |
Baseline
|
|
Pain sensitivity for cold stimuli
Tidsram: Baseline
|
Hypersensitivity for cold pain. the cold stimulus will be delivered with the TSA-2, using a thermode. |
Baseline
|
|
Pain sensitivity for electrical stimuli
Tidsram: Baseline
|
Hypersensitivity for electrical pain. The electrical stimulus will be given with the Digitimer, using an electrode. |
Baseline
|
|
Pain sensitivity for pressure
Tidsram: Baseline
|
Hypersensitivity for pressure pain. Pressure will be delivered using a digital algometer. |
Baseline
|
|
Function of the pain facilitating pathways
Tidsram: Baseline
|
Temporal summation will be measured. This gives an idea of the (dys)function of the endogenous pain facilitation system. |
Baseline
|
|
Function of the pain inhibiting pathways
Tidsram: Baseline
|
Conditioned pain modulation will be measured. This gives an idea of the (dys)function of the endogenous pain inhibiting system. A noxious conditioning heat stimulus will be given at the tibial anterior muscle. A test heat or pressure stimulus will be given at the temporalis muscle. The pain-inhibits-pain paradigm will be tested. |
Baseline
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Jessica Van Oosterwijck, Prof, Revalidatiewetenschappen en kinesitherapie
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
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
- ONZ-2023-0442
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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