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Clinical Trials/NCT05328635
NCT05328635
Completed
Not Applicable

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

Danish Headache Center1 site in 1 country58 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Traumatic Headache
Sponsor
Danish Headache Center
Enrollment
58
Locations
1
Primary Endpoint
Change in headache days
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
September 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Henrik Schytz

Principal investigator, MD and associate professor

Danish Headache Center

Eligibility Criteria

Inclusion Criteria

  • Patients with post-traumatic headache

Exclusion Criteria

  • Medication-overuse headache

Outcomes

Primary Outcomes

Change in headache days

Time Frame: 1 year

Headache days will be obtained via a validated questionaire

Rivermead post-concussion questionare score

Time Frame: 1 year

Rivermead is a validated questionaire to assess concussion symptoms

HADS-scores

Time Frame: 1 year

HADS = Hospital anxiety and depression scale. A validated tool to assesss depression and anxiety symptoms

Self-perceived health

Time Frame: 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

Time Frame: 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

Study Sites (1)

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