Signs of Central Sensitization in Tension-type Headache

Tension-Type Headache Clinical Trial

— CSTTH  

Official title:

Are Signs of Central Sensitization Present in Tension-type Headache?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06323720
• Other study ID #: ONZ-2023-0442
• Status: Recruiting
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Headache
• Tension-Type Headache

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