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Completed

NCT Number: NCT05328635

Post-traumatic Headache Multidisciplinary Study

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

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Key information

Conditions

Post-Traumatic Headache Brain Concussion Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Head Injuries, Closed Headache Disorders Headache Disorders, Secondary Nervous System Diseases Post-Concussion Syndrome Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danish Headache Center

Glostrup Municipality, 2600, Denmark

About this study

Pharmacological interventions are candesartan, amitritylin and gabapentin depending on the headache phenotype. In total 3 visits spanned over 1 year

Education is conducted as group sessions of up to 10 patients by two specialist nurses 2 x 90 min Physiotherapy is conducted as group sessions of up to 5 patients by physiotherapists 8 x 60 min plus 2 individual sessions.

Psychology is conducted as group sessions of up to 10 patients by psychologist 3x60 min plus option of 1 individual session.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with post-traumatic headache

-

Exclusion criteria

  • Medication-overuse headache

Treatment and study plan

Candesartan

Drug

Multdisciplinary approach

Other names: Amitriptylin, Gabapentin

Primary outcomes

  1. Change in headache days

    Time frame: 1 year

    Headache days will be obtained via a validated questionaire

  2. Rivermead post-concussion questionare score

    Time frame: 1 year

    Rivermead is a validated questionaire to assess concussion symptoms

  3. HADS-scores

    Time frame: 1 year

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

  4. Self-perceived health

    Time frame: 1 year

    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.

  5. Level of physical activity

    Time frame: 1 year

    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

Sponsors and collaborators

Lead sponsor

Danish Headache Center

Other

Registry information

Official study title

The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache

Acronym: PTHMS

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 14, 2022
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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