NCT05893004

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

November 6, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

May 28, 2023

Last Update Submit

September 26, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

Study Arms (1)

Test-Retest

EXPERIMENTAL

sample of convenience headache suffereres will be tested twice

Diagnostic Test: Headache Screening Questionnaire

Interventions

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.

Test-Retest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich University of applied sciences

Winterthur, 8401, Switzerland

Location

MeSH Terms

Conditions

Migraine DisordersTension-Type Headache

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Markus J Ernst, MSc

    Zurich University of Applied Sciences

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Phd.

Study Record Dates

First Submitted

May 28, 2023

First Posted

June 7, 2023

Study Start

November 6, 2023

Primary Completion

March 31, 2024

Study Completion

May 1, 2024

Last Updated

October 1, 2024

Record last verified: 2024-09

Locations