Signs of Central Sensitization in Tension-type Headache

NCT06323720 | Recruiting DMC

• 1 other identifier: ONZ-2023-0442
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Tension-Type Headache

Outcome Measures

Primary Outcomes (6)

• Pain sensitivity for heat stimuli

  Hypersensitivity for heat pain. The heat stimulus will be delivered with the TSA-2, using a thermode.

  Baseline

• Pain sensitivity for cold stimuli

  Hypersensitivity for cold pain. the cold stimulus will be delivered with the TSA-2, using a thermode.

  Baseline

• Pain sensitivity for electrical stimuli

  Hypersensitivity for electrical pain. The electrical stimulus will be given with the Digitimer, using an electrode.

  Baseline

• Pain sensitivity for pressure

  Hypersensitivity for pressure pain. Pressure will be delivered using a digital algometer.

  Baseline

• 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

• 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

Study Arms (3)

Episodic tension-type headache

Patients with 1 - 14 days of TTH/month.

Other: Quantitative Sensory Testing

Chronic tension-type headache

Patients with more than 14 days TTH/month

Other: Quantitative Sensory Testing

Healthy controls

Participants without tension-type headache

Other: Quantitative Sensory Testing

Interventions

Quantitative Sensory Testing OTHER

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; Episodic tension-type headache; Healthy controls

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will involve participation from various populations, specifically patients with episodic tension headache, patients with chronic tension headache, and healthy pain-free controls.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, East-Flanders, 9000, Belgium

RECRUITING

MeSH Terms

Conditions

Tension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Jessica Van Oosterwijck, Prof

  Revalidatiewetenschappen en kinesitherapie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Van Oosterwijck, Prof

CONTACT

+32 9 332 69 19; jessica.vanoosterwijck@ugent.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: March 21, 2024
• Study Start: February 23, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 1, 2024

Record last verified: 2024-02

Locations

BE (1)