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.
Clinical diagnosed with acute posttraumatic headache
Headache present for more than 15 days/month
Must understand written and spoken Danish
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
Parallel
The intervention group
BehavioralIs described in arm
Number of days with headache within the last week
The primary outcome is number of days with headache within the last week. Headache will be reported by a self-administered validated headache diary. Patients note every day if they experience any headache. The diary assesses days with headache graduated in intensity using a 1-3 scale (1= mild intensity and 3= severe intensity).
Headache intensity
Secondary outcomes measures are headache intensity during the last 24 hours and intensity during the last week evaluated using a numeric rating scale. Two questions will be posed: "On a scale from 0 (equals no pain) to 10 (worst imaginable pain), please specify the degree of pain due to headache during the last 24 hours and "On a scale from 0 (equals no pain) to 10 (worst imaginable pain), please specify the degree of pain due to headache during the last week?"
Headache disability
To measure the severity of headache the Headache Impact Test (HIT6) is used. The questionnaire is a reliable and validated tool used to measure how big an impact headache has on patients' ability to function at work, at school, at home and in social relations.
Coping strategies
Coping strategies, will be measured by the Coping strategy Questionnaire (CSQ). The validated questionnaire includes six coping strategy subscales: Ignoring pain, reinterpretation of pain, diverting attention, coping self-statements, catastrophizing, praying/hoping, and two subscales for behavioral strategies: Increasing activity levels and increasing pain behaviors.
Mental health
Mental health will be measured by The 36-item Short Form Survey (SF-36).This is a reliable and validated instrument frequently used across different patient groups. The instrument consists of 36 items on perceived health-related quality of life, with answers divided into eight scales measuring health concepts: physical functioning, role physical, role emotional, social functioning, bodily pain, mental health, vitality and general health. All eight scales contribute in different proportions to the scoring of both physical and mental measures.
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Esbjerg Hospital - University Hospital of Southern Denmark
Lead sponsor
Region of Southern Denmark
Collaborator
University of Southern Denmark
Collaborator
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