Signs of Central Sensitization in Tension-type Headache (CSTTH)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Tension-Type Headache
• Intervention / Treatment: Other: Quantitative Sensory Testing

• Study Type: Observational
• Enrollment (Estimated): 66

Contacts and Locations

• Study Contact: Name: Jessica van Oosterwijck, Prof; Phone Number: +32 9 332 69 19; Email: Jessica.VanOosterwijck@UGent.be

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • Recruiting
      • Ghent University
      • Contact: Jessica Van Oosterwijck, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Episodic tension-type headache; Patients with 1 - 14 days of TTH/month.	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.
Chronic tension-type headache; Patients with more than 14 days TTH/month	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.
Healthy controls; Participants without tension-type headache	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Ghent
• Investigators: Principal Investigator: Jessica Van Oosterwijck, Prof, Revalidatiewetenschappen en kinesitherapie

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 14, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders, Primary; Headache Disorders; Headache; Tension-Type Headache
• Other Study ID Numbers: ONZ-2023-0442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No