Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2025-12-25 @ 8:12 PM
Study NCT ID:
NCT05328635
Status:
COMPLETED
Last Update Posted:
2025-01-29
First Post:
2022-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-traumatic Headache Multidisciplinary Study
Sponsor:
Danish Headache Center
Organization:
Study Overview
Official Title:
The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache
Status:
COMPLETED
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PTHMS
Brief Summary:
The study will investigate the effect of pharmacological preventive treatment, education, physiotherapy and psychological counselling on the headache and associated symptoms in patients refered to the Danish Headache Center
Detailed Description:
Pharmacological interventions are candesartan, amitritylin and gabapentin depending on the headache phenotype. In total 3 visits spanned over 1 year
Education is conducted as group sessions of up to 10 patients by two specialist nurses 2 x 90 min Physiotherapy is conducted as group sessions of up to 5 patients by physiotherapists 8 x 60 min plus 2 individual sessions.
Psychology is conducted as group sessions of up to 10 patients by psychologist 3x60 min plus option of 1 individual session.
Education is conducted as group sessions of up to 10 patients by two specialist nurses 2 x 90 min Physiotherapy is conducted as group sessions of up to 5 patients by physiotherapists 8 x 60 min plus 2 individual sessions.
Psychology is conducted as group sessions of up to 10 patients by psychologist 3x60 min plus option of 1 individual session.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: