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Non-pharmacological Treatment of Patients at Risk of Developing Persistent Post-traumatic Headache: The PTHEENOT Study

StatusCompleted
PhaseNot applicable
Started
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Record History

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  1. Completed without a posted recruiting period Show 8 more changesShow less
    • Primary completion date changed from estimate of May 1, 2026 to Mar 24, 2026
    • Study sites: 0 to 1
    • Study completion date changed from estimate of May 5, 2027 to May 12, 2026
    • Start date changed from estimate of Dec 1, 2024 to Jan 15, 2025
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 7 of 7 entries
    • Study description revised
    • Study title expanded, about 3 words
  2. Start date: Aug 1, 2024 to Dec 1, 2024
    • Collaborators expanded, about 8 words
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06466499
Lead Sponsor Esbjerg Hospital - University Hospital of Southern Denmark
Collaborators: Region of Southern Denmark, University of Southern Denmark
Conditions
(from sponsor)		 Posttraumatic Headache
Related terms Post-Traumatic Headache
Enrollment 104 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov