Post-traumatic Headache Multidisciplinary Study

NCT05328635 | Completed FDA Drug

• 1 other identifier: DanishHC180322
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The study will investigate the effect of pharmacological preventive treatment, education, physiotherapy and psychological counselling on the headache and associated symptoms in patients refered to the Danish Headache Center

Conditions

Post-Traumatic Headache; Post-Concussion Syndrome

Outcome Measures

Primary Outcomes (5)

• Change in headache days

  Headache days will be obtained via a validated questionaire

  1 year

• Rivermead post-concussion questionare score

  Rivermead is a validated questionaire to assess concussion symptoms

  1 year

• HADS-scores

  HADS = Hospital anxiety and depression scale. A validated tool to assesss depression and anxiety symptoms

  1 year

• Self-perceived health

  based on EU-SILC validated question on self-perceived health ('How is your health in general?'), which contains five answering categories; 1) very good, 2) good, 3) fair, 4) bad, 5) very bad.

  1 year

• Level of physical activity

  Based on questionaire, where patients can choose: Low level of physical activity: primarily sedentary activities or light exercise at least 4 hours a week, or

  1 year

Interventions

Candesartan DRUG

Multdisciplinary approach

Also known as: Amitriptylin, Gabapentin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with a head trauma as a cause of the headache will be included in the study

You may qualify if:

• Patients with post-traumatic headache

You may not qualify if:

• Medication-overuse headache

Sponsors & Collaborators

• Danish Headache Center: lead

Study Sites (1)

Danish Headache Center

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Post-Traumatic Headache; Post-Concussion Syndrome

Interventions

candesartan; Amitriptyline; Gabapentin

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Concussion; Head Injuries, Closed; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD and associate professor

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 14, 2022
• Study Start: September 1, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)