NCT04877561

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
25 days until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

1.2 years

First QC Date

May 3, 2021

Last Update Submit

May 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Headache

    Nine item headache disability questionnaire (HDQ)

    June 21 to July 22

Secondary Outcomes (1)

  • Headache disorder

    June 21 to July 22

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects suffering from a headache condition and are due to that in physiotherapeutic care

You may qualify if:

  • 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

You may not qualify if:

  • not in physiotherapeutic care
  • in physiotherapeutic care due to other conditions not associated with headache
  • younger than 18 and older than 65 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zurich University of Applied Sciences

Winterthur, Canton of Zurich, 8400, Switzerland

Location

Related Publications (5)

  • 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.

    PMID: 17997346BACKGROUND
  • Stovner 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.

    PMID: 20473702BACKGROUND
  • Luedtke 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.

    PMID: 32051295BACKGROUND
  • Benz 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.

    PMID: 29523138BACKGROUND
  • Marx 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.

    PMID: 12954464BACKGROUND

MeSH Terms

Conditions

Headache Disorders

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Markus J Ernst, Master

    Zurich University of Applied Sciences

    STUDY DIRECTOR

Central Study Contacts

Markus J Ernst, Master

CONTACT

Dimo Ivanov, BSc

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow, MSc,

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 7, 2021

Study Start

June 1, 2021

Primary Completion

July 31, 2022

Study Completion

September 30, 2022

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

There is no intention to share the IPD

Locations