Post-traumatic Headache Multidisciplinary Study

Completed

• Conditions: Post-Traumatic Headache; Post-Concussion Syndrome

• Registration Number: NCT05328635
• Lead Sponsor: Danish Headache Center

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.

Study Timeline

• Study Start: 2021-09-01
• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-04-07
• Study First Posted: 2022-04-14
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

Patients with post-traumatic headache

Exclusion Criteria

• Medication-overuse headache

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in headache days	1 year	Headache days will be obtained via a validated questionaire
Rivermead post-concussion questionare score	1 year	Rivermead is a validated questionaire to assess concussion symptoms
HADS-scores	1 year	HADS = Hospital anxiety and depression scale. A validated tool to assesss depression and anxiety symptoms
Self-perceived health	1 year	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.
Level of physical activity	1 year	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

Trial Locations

Locations (1)

Danish Headache Center; 🇩🇰 Glostrup, Denmark