PhD-student
Sasha Revelius Gaj Baatz
Department of Neurology, The Research Unit of Neurology
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 06.05.2024 | |
| Slut | 06.05.2027 | |
Non-pharmacological treatment of patients at risk of developing persistent post-traumatic headache
Short summary
Persistent posttraumatic headache after mild traumatic brain injury is a common symptom and can be difficult to manage. Research is scarce and successful interventions are lacking. In order to reduce persistency and improve the quality of life, this project aims to evaluate the effect of an early interdisciplinary non-pharmacological treatment of patients at risk of developing persistent posttraumatic headache. The project is conducted as a mixed method study.
Rationale
Aim: The overall aim of the study is to design, test and evaluate the effect of an early interdisciplinary non-pharmacological treatment of patients at risk of developing persistent post-traumatic headache (PPTH) in order to prevent the development of PPTH 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. Background: Annually, traumatic brain injury (TBI) is estimated to affect 69 million individuals worldwide and mild TBI (mTBI) represent 70-90% of all TBIs. The most frequent reported complaint following a TBI is post-traumatic headache (PTH). The International Classification of Headache Disorders (ICHD), define PTH as a secondary headache disorder occurring within seven days after a trauma or injury to the head and/or neck. During the first three months after trauma/injury PTH is defined as acute, thereafter PTH is defined as persistent. The estimated prevalence of PTH ranges widely from 30-90%. Fortunately, the majority of people who develops PTH recover within the first days or weeks after trauma, however 15-65% still experience symptoms one year after trauma. However, this subgroup of patients are at risk of long-term disabilities and affected employment. Recent studies have shown that individuals whom experience PPTH have significantly higher risk of not returning work. Each year approximately 25.000 Danes suffers from a TBI, corresponding to an incidence of 450 per 100.000 inhabitants. However, these numbers are based on hospital admissions and do not include patients who are treated by a general practitioner or those who do not seek treatment at all. Therefore, there is an excessive uncertainty associated with these both incidence and prevalence. In the existing literature, there is a general agreement that development of PPTH is determined by psychological and behavioral factors. This is in line with our clinical experience, where it is commonly known that PPTH can be associated with depressive symptoms, symptoms of anxiety, decreased quality of life and experiences of stressful events earlier in life. Furthermore, studies on health-related quality of life in patients with PPTH, have found significantly lower life satisfaction, compared to the general population. PPTH patients reported their quality of life significantly lower in terms of physical- and social function and more often without affiliation to the labor market. They find themselves hypersensitive, easily emotionally agitated and overreacting to minor adverse situations. In addition, patients who also suffer from mental health problems are more likely to isolate themselves and use abusive substances as coping strategies. Additionally, patients with PPTH more frequently develop mental health problems such as depression, panic disorder and social anxiety disorder. A cohort study investigating potential risk factors for mTBI found that patients without physical problems and low levels of post-concussion- or post-traumatic stress early after injury, had a 90% chance of remaining free of headache symptoms. Non-pharmacological treatment: In 2021 The Danish Health Authority commissioned a set of National Clinical guidelines. The objective was to evaluate and summarize evidence for the effectiveness of non-pharmacological interventions in adults experiencing persistent headache symptoms after mTBI and to provide recommendations for clinical practice. The selected areas of interest were 1) Early information and advice, 2) Graded physical exercise, 3) Vestibular rehabilitation, 4) Manual treatment of neck and spine, 5) Oculomotor vision treatment 6) Psychological treatment, and 7) Interdisciplinary coordinated rehabilitative treatment. Based on low certainty of evidence, the guidelines provide weak recommendations for several of the areas. Even though there is a lack of evidence to substantiate the non-pharmacological treatment, there is a general agreement that non-pharmacological treatments should consist of an early, interdisciplinary treatment approach combining e.g. nursing consultation, physical therapy and psychological treatment (such as cognitive-behavioral therapies). Summarized, PPTH is a frequent problem that affect patients' quality of life and imposes a substantial direct and indirect cost, as a result of negative impact to patients' work life and daily life activities. The existing literature points to that an early interdisciplinary non-pharmacological treatment might reduce the persistency, but there is still a gap for larger, high-quality trials investigating the efficacy of early non-pharmacological psychological and behavioral interventions. In this study, persistent headache is defined as a chronic headache occurring 15 days or more per month and due to spontaneous recovering within the first three months, it is decided to include patients three to five months after mTBI.
Description of the cohort
The project will be conducted at the University Hospital of Southern Denmark, Esbjerg, Denmark. Patients will be recruited across various sectors: from the Emergency department at the University Hospital of Southern Denmark, Esbjerg, general practitioners, neurologists in the Region of Southern Denmark, as well as patient associations and social media postings. Patients with recent head trauma within two to six months may be included based on the following criteria: Inclusion criteria: Patients aged 18-60 years, diagnosed with acute post-traumatic headache present for >15 days per month. Participants must be able to communicate in written and spoken Danish. Exclusion criteria: Patients with a history of pre-existing primary or secondary headaches, dementia, or comorbidities involving neurological or psychiatric disorders are excluded.
Data and biological material
Patients will fill out questionnaires at baseline, post intervention and follow-up after 6 months. The questionnaires are completed electronically and stored anonymously in REDCap. The primary outcome is: The number of days with headache within the last week from baseline to twelve months follow-up. Headache will be reported by a self-administered validated headache diary. Patients note every day if they experience any headache. Secondary outcomes measures are: Headache intensity during the last 24 hours and intensity during the last week evaluated using a numeric rating scale. Severity of headache will be measured by The Headache Impact Test (HIT6). Coping strategies will be measured by the Coping strategy Questionnaire (CSQ). And Health-related quality of life including mental, physical, emotional and social functioning will be measured by the The 36-item Short Form Survey (SF-36). Furthermore, a customized question on number of sick leave days will be included.
Collaborating researchers and departments
The Department of Neurology, University hospital of Southern Denmark, Esbjerg