Post-Traumatic HeadachePTHMSNCT05328635
Post-traumatic Headache Multidisciplinary Study
An observational study of Post-Traumatic Headache and Post-Concussion Syndrome, run by Danish Headache Center at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Traumatic Headache, Post-Concussion Syndrome
- What is being tested?
- Candesartan
- How many people
- 58 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2021to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a head trauma as a cause of the headache will be included in the study
Who may be able to join
- Patients with post-traumatic headache
- -
Who cannot join
- Medication-overuse headache
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache
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
Read the detailed description
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.
- Conditions
- Post-Traumatic Headache, Post-Concussion Syndrome
- Being tested
- Candesartan
- Medical subject headings
- Post-Traumatic Headache, Post-Concussion Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CandesartanDrug
Also called Amitriptylin, Gabapentin
Multdisciplinary approach
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in headache days
Headache days will be obtained via a validated questionaire
Measured: 1 year
Rivermead post-concussion questionare score
Rivermead is a validated questionaire to assess concussion symptoms
Measured: 1 year
HADS-scores
HADS = Hospital anxiety and depression scale. A validated tool to assesss depression and anxiety symptoms
Measured: 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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Sep 2021
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Headache Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Henrik Schytz, Danish Headache Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05328635
- Sponsor's protocol ID
- DanishHC180322
- Acronym
- PTHMS
- Status last verified
- Jan 2025
- First submitted
- 18 Mar 2022
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wasfi Abd-Albaqi S, Kjeldgaard Madsen B, Salomon SM, Caspersen N, Kroll LS, Larsen K, Danielsen T, Thomsen ST, Gaj Baatz SR, Mose LS, Amin FM, Schytz HW. The effect of multidisciplinary open-label treatment in patients with persistent post-traumatic headache at two tertiary headache centers. Pain Manag. 2026 May;16(5):471-478. doi: 10.1080/17581869.2026.2638405. Epub 2026 Feb 27.
PubMed 41761605
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache
- ClinicalTrials.gov ID
- NCT05328635
- Acronym / sponsor ID
- PTHMS / DanishHC180322
- Conditions
- Post-Traumatic Headache, Post-Concussion Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Danish Headache CenterUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 14 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a head trauma as a cause of the headache will be included in the study
Key inclusion criteria (2 listed)
- Patients with post-traumatic headache
- -
Key exclusion criteria (1 listed)
- Medication-overuse headache
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CandesartanAlso: Amitriptylin, GabapentinMultdisciplinary approach | Drug | – |
Primary outcome
Change in headache days
Time frame: 1 year
Headache days will be obtained via a validated questionaire
Rivermead post-concussion questionare score
Time frame: 1 year
Rivermead is a validated questionaire to assess concussion symptoms
HADS-scores
Time frame: 1 year
HADS = Hospital anxiety and depression scale. A validated tool to assesss depression and anxiety symptoms
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Derived from this study: PubMed 41761605Wasfi Abd-Albaqi S, Kjeldgaard Madsen B, Salomon SM, Caspersen N, Kroll LS, Larsen K, Danielsen T, Thomsen ST, Gaj Baatz SR, Mose LS, Amin FM, Schytz HW. The effect of multidisciplinary open-label treatment in patients with persistent post-traumatic headache at two tertiary headache centers. Pain Manag. 2026 May;16(5):471-478. doi: 10.1080/17581869.2026.2638405. Epub 2026 Feb 27.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Traumatic Headache and Post-Concussion Syndrome, run by Danish Headache Center at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in headache days (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05328635, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.