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

The feasibility study will be performed prior to a randomized controlled trial and aim to assess the following: recruitment capability, data collection procedures and outcome measures, acceptability of the intervention, resources and ability to manage the study and intervention, and participant responses to the intervention.

Study population and recruitment The project will be conducted at the University Hospital of Southern Denmark. Patients will be recruited from the Emergency department. All patients hospitalized with mild traumatic brain injury (mTBI) will be asked to sign a statement of consent so the researcher is allowed to contact the patients for eligibility after three months. Participation in the study is voluntary. Patients will be informed about the feasibility nature of the study and included after oral consent. A neurological exam will be performed to assess final eligibility.

Patients are included 3-5 months after trauma and the intervention is initiated no later than six months after mTBI. In this study a sample size of 8 participants are chosen to assess feasibility.

Intervention The intervention will take place at the specialized Headache Clinic at the University Hospital of Southern Denmark. It will cover an interdisciplinary 5-week program with sessions from both psychologists and physiotherapists, all working at the Headache Clinic. The psychologist sessions will focus on topics regarding cognitive behavioural therapy, psychoeducation, occupational rehabilitation and work activity. The physiotherapeutic sessions will include a combination of exercises on neck tensions, relaxation therapies and advises on, how to return gradually to daily activities (social, cognitive, and physical activities, such as reading, working by the computer, house cleaning, exercising, and going out with friends). Furthermore, patients will get exercise handouts to do at home between sessions. Both psychologist and physiotherapist sessions will be group-based with 6-8 patients in each group. Once every week, the groups receive psychologist sessions lasting 90 minutes and afterwards physiotherapist sessions of 60 minutes.

The aim of the randomized controlled trial (RCT) is to investigate the effect of an early non-pharmacological treatment in patients at risk of developing persistent PTH. The null-hypothesis is that there is no difference between the groups, however the alternative hypothesis is that the intervention will result in reduced number of individuals with persistent headache 6 months after the trauma.