Clinical Trial

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

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Record status
This record was last updated December 2, 2024 (before its estimated May 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-06-13.
Trial Details
NCT Number NCT06466499
Lead Sponsor Esbjerg Hospital - University Hospital of Southern Denmark
Collaborators: Region of Southern Denmark, University of Southern Denmark
Conditions Posttraumatic Headache
Enrollment 104 participants
Start Date 2024-12-01
Primary Completion 2026-05-01 (estimated)
Study Completion 2027-05-05 (estimated)
Updated on ClinicalTrials.gov 2024-12-02