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

NCT06466499 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-12-02

No results posted yet for this study

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.

Conditions

  • Posttraumatic Headache

Interventions

BEHAVIORAL

The intervention group

Is described in arm

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER

  • University of Southern Denmark

    collaborator OTHER

  • Esbjerg Hospital - University Hospital of Southern Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2026-05-01
Completion
2027-05-05

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06466499 on ClinicalTrials.gov