Tension-Type HeadacheCSTTHNCT06323720
Signs of Central Sensitization in Tension-type Headache
An observational study of Tension-Type Headache, run by University Ghent at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tension-Type Headache
- What is being tested?
- Quantitative Sensory Testing
- How many people
- 52 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Feb 2024to 10 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- Athletes competing at a competitive level
- Not proficient in the Dutch language
- Currently pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tension-Type Headache
- Being tested
- Quantitative Sensory Testing
- Medical subject headings
- Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Sensory TestingOther
Assessment of the heat and cold pain thresholds, temporal summation, conditioned pain modulation, pressure pain thresholds, electrical pain thresholds, and withdrawal reflex.
| Study group | Role | What they receive |
|---|---|---|
| Episodic tension-type headache | Patients with 1 - 14 days of TTH/month. Receives: Other: Quantitative Sensory Testing | |
| Chronic tension-type headache | Patients with more than 14 days TTH/month Receives: Other: Quantitative Sensory Testing | |
| Healthy controls | Participants without tension-type headache Receives: Other: Quantitative Sensory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain sensitivity for heat stimuli
Hypersensitivity for heat pain. The heat stimulus will be delivered with the TSA-2, using a thermode.
Measured: Baseline
Pain sensitivity for cold stimuli
Hypersensitivity for cold pain. the cold stimulus will be delivered with the TSA-2, using a thermode.
Measured: Baseline
Pain sensitivity for electrical stimuli
Hypersensitivity for electrical pain. The electrical stimulus will be given with the Digitimer, using an electrode.
Measured: Baseline
Pain sensitivity for pressure
Hypersensitivity for pressure pain. Pressure will be delivered using a digital algometer.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start23 Feb 2024
- Primary completion30 Jul 2025
- Study completion10 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tension-Type HeadacheStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Van Oosterwijck, Prof, Principal investigator, Revalidatiewetenschappen en kinesitherapie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06323720
- Sponsor's protocol ID
- ONZ-2023-0442
- Acronym
- CSTTH
- Status last verified
- Nov 2026
- First submitted
- 14 Feb 2024
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Signs of Central Sensitization Present in Tension-type Headache?
- ClinicalTrials.gov ID
- NCT06323720
- Acronym / sponsor ID
- CSTTH / ONZ-2023-0442
- Conditions
- Tension-Type Headache
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 10 Oct 2026 (actual)
- First posted
- 21 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Episodic tension-type headache | – | Other: Quantitative Sensory TestingPatients with 1 - 14 days of TTH/month. |
| Chronic tension-type headache | – | Other: Quantitative Sensory TestingPatients with more than 14 days TTH/month |
| Healthy controls | – | Other: Quantitative Sensory TestingParticipants without tension-type headache |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative Sensory TestingAssessment of the heat and cold pain thresholds, temporal summation, conditioned pain modulation, pressure pain thresholds, electrical pain thresholds, and withdrawal reflex. | Other | Chronic tension-type headache, Episodic tension-type headache, Healthy controls |
Primary outcome
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 electrical stimuli
Time frame: Baseline
Hypersensitivity for electrical pain. The electrical stimulus will be given with the Digitimer, using an electrode.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Van Oosterwijck, Prof principal investigator
Revalidatiewetenschappen en kinesitherapie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tension-Type Headache, run by University Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain sensitivity for heat stimuli (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.