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

NCT06466499 | Not Yet Recruiting

• 1 other identifier: SashaRGN
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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. 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. 2.An experimental design; a randomized controlled trial to evaluate the effect of the early non-pharmacological treatment.
3. 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Headache intensity

  8 months

• Headache disability

  8 months

• Coping strategies

  8 months

• Mental health

  8 months

• Physical functioning

  8 months

Study Arms (2)

Control

NO INTERVENTION

The control group will receive the standard treatment, which is oral and written information about the characteristic symptoms after head trauma, specific signals to be aware of, when to contact the general practitioner and guidance of gradual return to daily activities

Intervention

EXPERIMENTAL

The intervention will cover an interdisciplinary 5-week program with sessions from both psychologists and physiotherapists. 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.

Behavioral: The intervention group

Interventions

The intervention group BEHAVIORAL

Is described in arm

Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosed with acute posttraumatic headache
• Headache present for more than 15 days/month
• Must understand written and spoken Danish

You may not qualify if:

• 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

Sponsors & Collaborators

• Esbjerg Hospital - University Hospital of Southern Denmark: lead
• Region of Southern Denmark: collaborator
• University of Southern Denmark: collaborator

MeSH Terms

Conditions

Post-Traumatic Headache

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Sasha Gaj Baatz, cand.scient.san.publ.

CONTACT

+45 25127766; srgnielsen@health.sdu.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In the RCT measurements will be conducted three times; baseline, post intervention, and at six months follow-up.

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 20, 2024
• Study Start: December 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 5, 2027
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share