Evaluating Medrol Dose Pack for treating headaches after concussions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the effectiveness of corticosteroids, specifically the Medrol Dose Pack, in reducing the frequency and intensity of acute post-concussive headaches. The investigators hypothesize that corticosteroid treatment will not only alleviate headaches but also decrease other related symptoms, facilitating a quicker return to normal activities such as school, work, or sports. The study is novel as it focuses on individuals suffering from post-concussion headaches, a condition that currently lacks established treatment guidelines. Participants will be monitored for their response to the medication over a specified period.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of signed and dated informed consent form (in person or via telehealth)
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged \>18 years old
4. Ability to take oral medication and be willing to adhere to the study regimen as described in this protocol
5. Patients presenting with all types of post-concussive headache with \>5/10 in severity on the numerical analog scale.
6. Headache that occurs for \> 4 hours per day
7. Headache that occurs every day
8. Headache that began after concussion, patient was diagnosed at an outpatient clinic or was hospitalized
9. Headache developed within 7 days post-injury and patient presenting within 30 days from initial trauma
10. A diagnosis of concussion.
11. If a patient is taking another pain medication, this still be included in the stud

Exclusion Criteria:

1. Any evidence of known intracranial hemorrhage on neuroimaging
2. Headache developing after 7 days post injury and patient presenting after 30 days from initial trauma
3. Headache occurs \< 4 hours per day
4. Headache does not occur daily
5. Age \< or = 18
6. Headache is \< 5 in severity on numerical analog scale
7. Presence of increase in intracranial pressure or papilledema
8. Any contraindication to corticosteroids
9. Allergy or sensitivity to corticosteroids
10. Active Tuberculosis
11. Active pregnancy
12. Currently on corticosteroids for another reason
13. Participants with fungal infection

Where it's running

• Northwell Health - North Shore University Hospital
  Manhasset, New York, United States Recruiting

Study contacts

• Principal investigator: Jamie S Ullman, MD — Hofstra Northwell School of Medicine
• Study coordinator: Jamie Ullman, MD
• Email: Jullman1@northwell.edu
• Phone: (516) 562 4300

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.