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Clinical Trials/NCT05893004
NCT05893004CompletedNot Applicable

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

Markus J. Ernst2 sites in 1 country61 target enrollmentStarted: November 6, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
61
Locations
2
Primary Endpoint
Kappe Value

Study Overview

Brief 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?

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.

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Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Markus J. Ernst
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Markus J. Ernst

Phd.

Zurich University of Applied Sciences

Study Sites (2)

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