Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00298142
Status:
TERMINATED
Last Update Posted:
2009-10-06
First Post:
2006-02-27
Brief Title:
Management of Headache Disorders A Clinical Trial Screening for Prognostic Patient Characteristics
Sponsor:
Vrije Universiteit Brussel
Organization:
Vrije Universiteit Brussel
Study Overview
Official Title:
A Prospective Randomised Clinical Trial to Investigate the Management of Headache Disorders Study to Identify Prognostic Patient Characteristics and to Investigate the Additional Value of Physio-Manual Therapy
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Insufficient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The management of headache disorders is too often based upon trial and error or on personal beliefs and opinions Seldom it is based on scientific arguments Therefore the identification of prognostic patient characteristics is mandatory as this will lead to a more precise referral of headache patientsA prospective cohortstudy is designed to identify these prognostic patient characteristics After testing 186 headache patients migraine tension type headache and cervicogenic headache will be randomly allocated to one of two treatment groups Testing includes the fulfillment of questionnaires Headache Diagnosis Questionnaire Headache Inventory Questionnaire and the Headache Impact Test and physical tests Thermal Stimuli Cervical Spine examination and Pressure Algometry Treatment groups are a usual care group administered by a medical doctor and a usual care plus physio- manual therapy treatment After six weeks of treatment subjects will complete the headache inventory list and the Headache Impact Test a second time The perceived effect will be registered allowing the distinction between responders positive effect and non-responders no effect or worse Logistic regression-analysis will be used to identify the specific patient characteristics of the responders and the non-responders Secondly the additional value of the physio- manual therapy intervention will be examined Follow-up measurements up to 52 weeks are provided
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OZR-HA G 815 | None | None | None |
| OZR-VUB 997 | None | None | None |