Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04877561
Other study ID # ZUAS HDQ
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date September 30, 2022

Study information

Verified date May 2021
Source Zurich University of Applied Sciences
Contact Markus J Ernst, Master
Phone +41 58 9346448
Email markus.ernst@zhaw.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date September 30, 2022
Est. primary completion date July 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - not in physiotherapeutic care - in physiotherapeutic care due to other conditions not associated with headache - younger than 18 and older than 65 years

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Zurich University of Applied Sciences Winterthur Zurich

Sponsors (1)

Lead Sponsor Collaborator
Zurich University of Applied Sciences

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

Luedtke K, Basener A, Bedei S, Castien R, Chaibi A, Falla D, Fernández-de-Las-Peñas 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. — View Citation

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. — View Citation

Niere K, Quin A. Development of a headache-specific disability questionnaire for patients attending physiotherapy. Man Ther. 2009 Feb;14(1):45-51. Epub 2007 Nov 7. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Headache Nine item headache disability questionnaire (HDQ) June 21 to July 22
Secondary Headache disorder Migraine, Tension-type headache, other June 21 to July 22
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03632928 - Day to Day Variation of Pressure Pain Threshold and Muscle Hardness
Completed NCT00246350 - Spinal Manipulation for Treatment of Chronic Headaches Phase 2
Completed NCT05404113 - Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache N/A
Recruiting NCT03416114 - RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary Headache Centres N/A
Enrolling by invitation NCT04976985 - Osteopathic Manipulative Treatment and Migraine Headaches N/A
Completed NCT05153876 - An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
Recruiting NCT06041997 - Smartphone Use Restriction as Treatment of Primary Headache N/A
Active, not recruiting NCT04936321 - Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial N/A
Completed NCT04220580 - Multiomics After Cold Pressor Test of People Who Are Unable to Have Headache N/A
Completed NCT03385174 - Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow N/A
Completed NCT03137147 - Intervention for Sleep and Pain in Youth N/A
Completed NCT02910921 - Individualized Prediction of Migraine Attacks Using a Mobile Phone App and Fitbit
Recruiting NCT05619354 - Validity and Reliability of the Dutch HDI
Recruiting NCT06206772 - Resting State Functional Connectivity in Cluster Headache
Completed NCT02662972 - Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues. Phase 1/Phase 2
Terminated NCT02624661 - Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique Phase 1/Phase 2
Completed NCT05381012 - Fibromyalgia Syndrome on Patients With Chronic Migraine N/A
Completed NCT04891848 - Assessment of Inflammation in Primary Headaches
Recruiting NCT04715685 - Mind Body Balance for Pediatric Migraine N/A
Completed NCT00457496 - Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities Phase 3