Signs of Central Sensitization in Tension-type Headache

Recruiting

• Conditions: Tension-Type Headache
• Interventions: Other: Quantitative Sensory Testing

• Registration Number: NCT06323720
• Lead Sponsor: University Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-14
• Study Start: 2024-02-23
• Study First Submitted QC: 2024-03-14
• Study First Posted: 2024-03-21
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-04-01
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 66

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Episodic tension-type headache	Quantitative Sensory Testing	Patients with 1 - 14 days of TTH/month.
Chronic tension-type headache	Quantitative Sensory Testing	Patients with more than 14 days TTH/month
Healthy controls	Quantitative Sensory Testing	Participants without tension-type headache

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Ghent, East-Flanders, Belgium