PTHMS: Post-traumatic Headache Multidisciplinary Study

• Sponsor: Danish Headache Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05328635
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Headache; Post-Concussion Syndrome	Drug: Candesartan

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

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Effect of Multidisciplinary Intervention on Patients With Persistent Post-traumatic Headache
• Actual Study Start Date: Sep 1, 2021
• Anticipated Primary Completion Date: Sep 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Outcome Measures

Primary Outcome Measures

1. Change in headache days [1 year]

   Headache days will be obtained via a validated questionaire

2. Rivermead post-concussion questionare score [1 year]

   Rivermead is a validated questionaire to assess concussion symptoms

3. HADS-scores [1 year]

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

4. Self-perceived health [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 [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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients with post-traumatic headache

-

Exclusion Criteria:

• Medication-overuse headache

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Danish Headache Center	Glostrup		Denmark	2600

Sponsors and Collaborators

• Danish Headache Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Henrik Schytz, Principal investigator, MD and associate professor, Danish Headache Center
• ClinicalTrials.gov Identifier: NCT05328635
• Other Study ID Numbers: DanishHC180322
• First Posted: Apr 14, 2022
• Last Update Posted: Apr 14, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Post-Concussion Syndrome; Post-Traumatic Headache; Headache; Candesartan; Gabapentin

Study Results

No Results Posted as of Apr 14, 2022