Non-pharmacological Treatment of Patients at Risk of Developing Persistent Posttraumatic Headache
NCT Number: NCT06466499
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Posttraumatic Headache
Interventions: BEHAVIORAL: The intervention group
Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sex: ALL
Age: ADULT
Enrollment: 104
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: PREVENTION
Start Date: 2024-08-01
Completion Date: 2027-05-05

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.

Primary Outcome Measures: 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)., 8 months
Secondary Outcome Measures: 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?", 8 months|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., 8 months|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., 8 months|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., 8 months|Physical functioning, Physical functioning will be measured by the SF-36, 8 months|Emotional functioning, Emotional functioning will be measured by the SF-36, 8 months|Number of sick leave days, This will be a customized question in the survey, 8 months