Headache DisordersNCT04877561
Test-Retest Reliability of the German Version of the Headache Disability Questionnaire (HDQ).
An observational study of Headache Disorders, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
a translated and cultural adapted version of the HDQ will be tested on two occasions with headache patients who are currently in physiotherapeutic treatment due to their headache condition Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Headache Disorders
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2021to 30 Sep 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects suffering from a headache condition and are due to that in physiotherapeutic care
Who may be able to join
- within physiotherapeutic care due to headache for no longer than 3 months
- headache conditions for at least one month and at least once /month
- live in Switzerland
- give informed consent
Who cannot join
- not in physiotherapeutic care
- in physiotherapeutic care due to other conditions not associated with headache
- younger than 18 and older than 65 years
Trial locations and contacts
1 site in 1 country.
Dimo Ivanov, BSc contact
Switzerland1 site
Zurich University of Applied Sciences
Winterthur, Canton of Zurich, 8400
About this study
Official title: Translation, Trans-cultural Adaptations and Test-retest Reliability of the Headache Disability Questionnaire (HDQ)
a translated and cultural adapted version of the HDQ will be tested on two occasions with headache patients who are currently in physiotherapeutic treatment due to their headache condition
Read the detailed description
The test-retest reliability of the German version of the HDQ will be tested to assess the reproducibility of the test results with a stable condition of the participants over a short period of time. For this purpose, it is planned to administer the questionnaire twice in row at an interval of 48 - 72 hours to headache patients in outpatient physiotherapy. The chosen setting limits the sample to a common intervention measure (physiotherapy), so that primary and secondary headache types can be included and the requirements of the original study can be maintained. In the period between the two tests, subjects should not receive physiotherapy, because it can often have different effects on headache. This can lead to uneven changes in the sample and affect the variance of the test results. However, subjects are allowed to take their usual medications. To avoid recall bias, an online survey tool (RedCAP) to conduct the questionnaire will be used. It is designed so that, only one question appears per slide, no overview of responses is allowed and the questions are displayed in a different order at the second testing. The lower prevalence of headaches after the age of 65 years is taken into account in the inclusion criteria.
- Conditions
- Headache Disorders
- Medical subject headings
- Headache Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache
Nine item headache disability questionnaire (HDQ)
Measured: June 21 to July 22
Secondary outcomes (1)
Headache disorder
Migraine, Tension-type headache, other
Measured: June 21 to July 22
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jun 2021 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Markus J. Ernst, Zurich University of Applied Sciences
- Investigators
- Markus J Ernst, Master, Study director, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877561
- Sponsor's protocol ID
- ZUAS HDQ
- Status last verified
- May 2021
- First submitted
- 3 May 2021
- Last updated
- 12 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no intention to share the IPD
Publications
Niere K, Quin A. Development of a headache-specific disability questionnaire for patients attending physiotherapy. Man Ther. 2009 Feb;14(1):45-51. doi: 10.1016/j.math.2007.09.006. Epub 2007 Nov 7.
PubMed 17997346Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.
PubMed 20473702Luedtke K, Basener A, Bedei S, Castien R, Chaibi A, Falla D, Fernandez-de-Las-Penas C, Gustafsson M, Hall T, Jull G, Kropp P, Madsen BK, Schaefer B, Seng E, Steen C, Tuchin P, von Piekartz H, Wollesen B. Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study. BMJ Open. 2020 Feb 12;10(2):e029855. doi: 10.1136/bmjopen-2019-029855.
PubMed 32051295Benz T, Lehmann S, Gantenbein AR, Sandor PS, Stewart WF, Elfering A, Aeschlimann AG, Angst F. Translation, cross-cultural adaptation and reliability of the German version of the migraine disability assessment (MIDAS) questionnaire. Health Qual Life Outcomes. 2018 Mar 9;16(1):42. doi: 10.1186/s12955-018-0871-5.
PubMed 29523138Marx RG, Menezes A, Horovitz L, Jones EC, Warren RF. A comparison of two time intervals for test-retest reliability of health status instruments. J Clin Epidemiol. 2003 Aug;56(8):730-5. doi: 10.1016/s0895-4356(03)00084-2.
PubMed 12954464
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation, Trans-cultural Adaptations and Test-retest Reliability of the Headache Disability Questionnaire (HDQ)
- ClinicalTrials.gov ID
- NCT04877561
- Acronym / sponsor ID
- ZUAS HDQ
- Conditions
- Headache Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 7 May 2021 (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.
a translated and cultural adapted version of the HDQ will be tested on two occasions with headache patients who are currently in physiotherapeutic treatment due to their headache condition
Detailed description
The test-retest reliability of the German version of the HDQ will be tested to assess the reproducibility of the test results with a stable condition of the participants over a short period of time. For this purpose, it is planned to administer the questionnaire twice in row at an interval of 48 - 72 hours to headache patients in outpatient physiotherapy. The chosen setting limits the sample to a common intervention measure (physiotherapy), so that primary and secondary headache types can be included and the requirements of the original study can be maintained. In the period between the two tests, subjects should not receive physiotherapy, because it can often have different effects on headache. This can lead to uneven changes in the sample and affect the variance of the test results. However, subjects are allowed to take their usual medications. To avoid recall bias, an online survey tool (RedCAP) to conduct the questionnaire will be used. It is designed so that, only one question appears per slide, no overview of responses is allowed and the questions are displayed in a different order at the second testing. The lower prevalence of headaches after the age of 65 years is taken into account in the inclusion criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects suffering from a headache condition and are due to that in physiotherapeutic care
Key inclusion criteria (4 listed)
- within physiotherapeutic care due to headache for no longer than 3 months
- headache conditions for at least one month and at least once /month
- live in Switzerland
- give informed consent
Key exclusion criteria (3 listed)
- not in physiotherapeutic care
- in physiotherapeutic care due to other conditions not associated with headache
- younger than 18 and older than 65 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Headache
Time frame: June 21 to July 22
Nine item headache disability questionnaire (HDQ)
1 secondary outcome
Headache disorder
Time frame: June 21 to July 22
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2021.
- Background: PubMed 17997346Niere K, Quin A. Development of a headache-specific disability questionnaire for patients attending physiotherapy. Man Ther. 2009 Feb;14(1):45-51. doi: 10.1016/j.math.2007.09.006. Epub 2007 Nov 7.
- Background: PubMed 20473702Stovner LJ, Andree C. Prevalence of headache in Europe: a review for the Eurolight project. J Headache Pain. 2010 Aug;11(4):289-99. doi: 10.1007/s10194-010-0217-0. Epub 2010 May 16.
- Background: PubMed 32051295Luedtke K, Basener A, Bedei S, Castien R, Chaibi A, Falla D, Fernandez-de-Las-Penas C, Gustafsson M, Hall T, Jull G, Kropp P, Madsen BK, Schaefer B, Seng E, Steen C, Tuchin P, von Piekartz H, Wollesen B. Outcome measures for assessing the effectiveness of non-pharmacological interventions in frequent episodic or chronic migraine: a Delphi study. BMJ Open. 2020 Feb 12;10(2):e029855. doi: 10.1136/bmjopen-2019-029855.
- Background: PubMed 29523138Benz T, Lehmann S, Gantenbein AR, Sandor PS, Stewart WF, Elfering A, Aeschlimann AG, Angst F. Translation, cross-cultural adaptation and reliability of the German version of the migraine disability assessment (MIDAS) questionnaire. Health Qual Life Outcomes. 2018 Mar 9;16(1):42. doi: 10.1186/s12955-018-0871-5.
- Background: PubMed 12954464Marx RG, Menezes A, Horovitz L, Jones EC, Warren RF. A comparison of two time intervals for test-retest reliability of health status instruments. J Clin Epidemiol. 2003 Aug;56(8):730-5. doi: 10.1016/s0895-4356(03)00084-2.
- Individual participant dataSharing planned: No. There is no intention to share the IPD
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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.
Dimo Ivanov, BSc contact
Markus J Ernst, Master 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?
An observational study of Headache Disorders, run by Zurich University of Applied Sciences 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: status not confirmed, as of the sponsor's last update on 12 May 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Markus J Ernst, Master (+41 58 9346448, markus.ernst@zhaw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache (time frame: June 21 to July 22). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04877561, which also lists 5 linked publications.
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 12 May 2021.