Non-pharmacological Treatment of Patients at Risk of Developing Persistent Posttraumatic Headache

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorEsbjerg Hospital - University Hospital of Southern Denmark

About this trial

The goal of this mixed method study is to test and evaluate the effect of an early interdisciplinary non-pharmacological treatment of patients at risk of developing persistent posttraumatic headache in order to prevent the development of persistent posttraumatic headache and thereby, reduce persistency and improve the quality of life. Furthermore, to gain knowledge on and a deeper understanding of the patients' perspective and experience of the treatment.

The project consists of 3 sub studies:

1. A feasibility study; with the purpose of exploring the feasibility of an early non-pharmacological intervention for patients with persistent posttraumatic headache after mild traumatic brain injury. 2. An experimental design; a randomized controlled trial to evaluate the effect of the early non-pharmacological treatment. 3. A qualitative focus group interview study; to get a more nuanced knowledge of patients' experience with the non-pharmacological treatment related to post traumatic headache.

Eligibility criteria

Qualifiers

Clinical diagnosed with acute posttraumatic headache

Headache present for more than 15 days/month

Must understand written and spoken Danish

Disqualifiers

History of pre-existing primary or secondary headache

Dementia or comorbidity with neurological disorders

Psychiatric disorders

Participants who cannot collaborate in relation to the intervention

Trial design

Treatments tested in this trial

  • The intervention group

Treatment groups

104 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Esbjerg Hospital - University Hospital of Southern Denmark

Lead sponsor

Region of Southern Denmark

Collaborator

University of Southern Denmark

Collaborator