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Clinical Trials/NCT06323720
NCT06323720RecruitingNot Applicable

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

University Ghent1 site in 1 country66 target enrollmentStarted: February 23, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
66
Locations
1
Primary Endpoint
Pain sensitivity for heat stimuli

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Pain sensitivity for heat stimuli

Time Frame: Baseline

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

Pain sensitivity for cold stimuli

Time Frame: Baseline

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

Pain sensitivity for pressure

Time Frame: Baseline

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

Function of the pain facilitating pathways

Time Frame: 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

Time Frame: 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

Time Frame: Baseline

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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