MigraineGUR-HSQNCT05893004
German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.
A study testing Headache Screening Questionnaire in people with Migraine and Tension-Type Headache, run by Markus J. Ernst at 1 site in Switzerland.
Trial summary
The goal of this study is to learn more about the Headache Screening Questionnaire in people with Headache. The main question is: Does the lower limit of a 95% confidence interval of the HSQ in physiotherapy during a period of 2 to 4 weeks reach at least 0.4? Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Migraine, Tension-Type Headache
- What is being tested?
- Headache Screening Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Nov 2023to 1 May 2024
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are older than 18 years,
- live in Switzerland
- speak and understand German
- have had multiple headache episodes of the same or similar type
Who cannot join
- individuals with other known neurological conditions,
- known cognitive impairment
- known secondary headache types
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to learn more about the Headache Screening Questionnaire in people with Headache. The main question is:
Does the lower limit of a 95% confidence interval of the HSQ in physiotherapy during a period of 2 to 4 weeks reach at least 0.4?
Read the detailed description
Data are collected using the REDCap web application (https://redcap.zhaw.ch/). REDCap is designed for the creation and administration of online surveys. Respondents can access the survey directly via a QR code or link and complete the screening questionnaire via smartphone or computer. In a first step, the participating persons are included or excluded based on the criteria mentioned (chapter: Proband:innen). Once eligibility has been confirmed, the HSQ is completed online for the first time in a second step. After that, the test persons will receive a reminder e-mail after 2 weeks to complete the retest online. After the reminder email the test persons have 2 weeks to complete the retest. Those who participate later will be excluded and not included in the data analysis. In addition, the retest asks whether the headaches have changed compared to the test due to the physiotherapeutic treatment. This is asked with a three Likert scale (not changed, slightly changed, strongly changed). The severely changed headaches are not included in the analysis.
Translated with www.DeepL.com/Translator (free version)
- Conditions
- Migraine, Tension-Type Headache
- Being tested
- Headache Screening Questionnaire
- Medical subject headings
- Migraine Disorders, Tension-Type Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headache Screening QuestionnaireDiagnostic test
The Dutch Headache Screening Questionnaire (HSQ) is the only screening questionnaire based on ICHD-3 which has at least moderate confidence in its criterion validity according to GRADE. The HSQ has already been translated into Portuguese and validated5. The HSQ has only 8 items and requires little time to complete. Due to its good sensitivity, the HSQ screening questionnaire is particularly well suited to exclude migraine.
| Study group | Role | What they receive |
|---|---|---|
| Test-Retest | Experimental | sample of convenience headache suffereres will be tested twice Receives: Diagnostic Test: Headache Screening Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kappe Value
The HSQ uses nominal variables for screening the two primary headaches with defined cut-offs of 6 and 8 points for migraine and TTH, respectively. Therefore, for the test-retest reliability analysis, a Cohen's kappa with corresponding 95% confidence interval is calculated for both migraine and TTH.
Measured: Participants are assessed based on criteria (chapter: participants). Eligible individuals complete the HSQ online. A reminder email is sent after 2 weeks for the retest. Participants have 2 weeks to complete it. Late participants are excluded from analys
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start6 Nov 2023
- Primary completion31 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Markus J. Ernst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Markus J. Ernst, Zurich University of Applied Sciences
- Investigators
- Markus J Ernst, MSc, Study director, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05893004
- Sponsor's protocol ID
- GUR-HSQ
- Acronym
- GUR-HSQ
- Status last verified
- Sep 2024
- First submitted
- 28 May 2023
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability Study.
- ClinicalTrials.gov ID
- NCT05893004
- Acronym / sponsor ID
- GUR-HSQ / GUR-HSQ
- Conditions
- Migraine, Tension-Type Headache
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Markus J. ErnstUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 7 Jun 2023 (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 study is to learn more about the Headache Screening Questionnaire in people with Headache. The main question is:
Does the lower limit of a 95% confidence interval of the HSQ in physiotherapy during a period of 2 to 4 weeks reach at least 0.4?
Detailed description
Data are collected using the REDCap web application (https://redcap.zhaw.ch/). REDCap is designed for the creation and administration of online surveys. Respondents can access the survey directly via a QR code or link and complete the screening questionnaire via smartphone or computer. In a first step, the participating persons are included or excluded based on the criteria mentioned (chapter: Proband:innen). Once eligibility has been confirmed, the HSQ is completed online for the first time in a second step. After that, the test persons will receive a reminder e-mail after 2 weeks to complete the retest online. After the reminder email the test persons have 2 weeks to complete the retest. Those who participate later will be excluded and not included in the data analysis. In addition, the retest asks whether the headaches have changed compared to the test due to the physiotherapeutic treatment. This is asked with a three Likert scale (not changed, slightly changed, strongly changed). The severely changed headaches are not included in the analysis.
Translated with www.DeepL.com/Translator (free version)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test-Retest | Experimental | Diagnostic Test: Headache Screening Questionnairesample of convenience headache suffereres will be tested twice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals who are older than 18 years,
- live in Switzerland
- speak and understand German
- have had multiple headache episodes of the same or similar type
Key exclusion criteria (3 listed)
- individuals with other known neurological conditions,
- known cognitive impairment
- known secondary headache types
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 |
|---|---|---|
| Headache Screening QuestionnaireThe Dutch Headache Screening Questionnaire (HSQ) is the only screening questionnaire based on ICHD-3 which has at least moderate confidence in its criterion validity according to GRADE. The HSQ has already been translated into Portuguese and validated5. The HSQ has only 8 items and requires little time to complete. Due to its good sensitivity, the HSQ screening questionnaire is particularly well suited to exclude migraine. | Diagnostic test | Test-Retest |
Primary outcome
Kappe Value
Time frame: Participants are assessed based on criteria (chapter: participants). Eligible individuals complete the HSQ online. A reminder email is sent after 2 weeks for the retest. Participants have 2 weeks to complete it. Late participants are excluded from analys
The HSQ uses nominal variables for screening the two primary headaches with defined cut-offs of 6 and 8 points for migraine and TTH, respectively. Therefore, for the test-retest reliability analysis, a Cohen's kappa with corresponding 95% confidence interval is calculated for both migraine and TTH.
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 1 Oct 2024.
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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.
Markus J Ernst, MSc study director
Zurich University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headache Screening Questionnaire in people with Migraine and Tension-Type Headache, run by Markus J. Ernst at 1 site in Switzerland.
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 4 inclusion and 3 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 1 Oct 2024. 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 Switzerland. 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?
Kappe Value (time frame: Participants are assessed based on criteria (chapter: participants). Eligible individuals complete the HSQ online. A reminder email is sent after 2 weeks for the retest. Participants have 2 weeks to complete it. Late participants are excluded from analys). 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 1 Oct 2024.