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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06323720
Other study ID # ONZ-2023-0442
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 23, 2024
Est. completion date December 2025

Study information

Verified date February 2024
Source University Ghent
Contact Jessica Van Oosterwijck, Prof
Phone +32 9 332 69 19
Email jessica.vanoosterwijck@ugent.be
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date December 2025
Est. primary completion date July 2025
Accepts healthy volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: 1. Diagnosis of tension headache according to globally recognized criteria (ICHD-3) or verified by a physician 2. Diagnosis of tension headache confirmed by a questionnaire (Headache Screening Questionnaire) 3. Not pregnant or given birth in the past year since a change in hormone levels can affect pain experience 4. Adults between the ages of 18 and 65 5. Proficient in the Dutch language Exclusion Criteria: 1. Other diagnosis of headache or a mixed form 2. Other existing condition involving central nervous system sensitivity 3. Other structural neurological syndromes 4. Any condition involving the brain in the past 5. Procedure on the head, neck, or shoulder in the past 3 years 6. Currently suffering from a psychiatric condition 7. Athletes competing at a competitive level 8. Not proficient in the Dutch language 9. Currently pregnant.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Quantitative Sensory Testing
Assessment of the heat and cold pain thresholds, temporal summation, conditioned pain modulation, pressure pain thresholds, electrical pain thresholds, and withdrawal reflex.

Locations

Country Name City State
Belgium Ghent University Ghent East-Flanders

Sponsors (1)

Lead Sponsor Collaborator
University Ghent

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain sensitivity for heat stimuli Hypersensitivity for heat pain. The heat stimulus will be delivered with the TSA-2, using a thermode. Baseline
Primary Pain sensitivity for cold stimuli Hypersensitivity for cold pain. the cold stimulus will be delivered with the TSA-2, using a thermode. Baseline
Primary Pain sensitivity for electrical stimuli Hypersensitivity for electrical pain. The electrical stimulus will be given with the Digitimer, using an electrode. Baseline
Primary Pain sensitivity for pressure Hypersensitivity for pressure pain. Pressure will be delivered using a digital algometer. Baseline
Primary Function of the pain facilitating pathways Temporal summation will be measured. This gives an idea of the (dys)function of the endogenous pain facilitation system. Baseline
Primary Function of the pain inhibiting pathways 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
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