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NCT05328635 Clinical Trial

Post-traumatic Headache Multidisciplinary Study

Post-Concussion Syndrome Clinical Trial

— PTHMS  

Official title:
The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05328635
Other study ID # DanishHC180322
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date December 1, 2024

Study information
Verified date April 2022
Source Danish Headache Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients with post-traumatic headache - Exclusion Criteria: - Medication-overuse headache

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Candesartan
Multdisciplinary approach

Locations
Country Name City State
Denmark Danish Headache Center Glostrup

Sponsors (1)
Lead Sponsor Collaborator
Danish Headache Center

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in headache days Headache days will be obtained via a validated questionaire 1 year
Primary Rivermead post-concussion questionare score Rivermead is a validated questionaire to assess concussion symptoms 1 year
Primary HADS-scores HADS = Hospital anxiety and depression scale. A validated tool to assesss depression and anxiety symptoms 1 year
Primary Self-perceived health based on EU-SILC validated question on self-perceived health ('How is your health in general?'), which contains five answering categories; 1) very good, 2) good, 3) fair, 4) bad, 5) very bad. 1 year
Primary Level of physical activity Based on questionaire, where patients can choose: Low level of physical activity: primarily sedentary activities or light exercise at least 4 hours a week, or 1 year
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