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
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Headache
• Post-Concussion Syndrome
• Post-Traumatic Headache

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