The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Danish Headache Center
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Change in headache days
Study 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Henrik Schytz
Principal investigator, MD and associate professor
Danish Headache Center