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OpenTrials
Completed

NCT Number: NCT05893004

German Translation and Cross-cultural Adaptation of the Headache Screening Questionnaire (HSQ) Followed by a Test-retest Reliability 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?

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zurich University of applied sciences

Winterthur, 8401, Switzerland

About this study

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.

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • individuals with other known neurological conditions,
  • known cognitive impairment
  • known secondary headache types

Treatment and study plan

Headache Screening Questionnaire

Diagnostic 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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Markus J. Ernst

Other

Registry information

Acronym: GUR-HSQ

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 7, 2023
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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