Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches
Assessment of the Efficacy of Medrol Dose Pack for Post-Concussive Headaches
Northwell Health
25 participants
Apr 1, 2021
OBSERVATIONAL
Conditions
Summary
This novel pilot project will assess the effectiveness of corticosteroids in treatment of acute post-concussion headache. The investigators hypothesize that the use of corticosteroids will cause significant headache reduction in frequency and/or intensity than individuals who undergo the current standard of care. Additionally, the investigators hypothesize that corticosteroid use will lead to a reduction in other somatic symptoms including vestibular symptoms, leading to quicker return to school, work, and/or ability to play sports.
Eligibility
Inclusion Criteria11
- Provision of signed and dated informed consent form (in person or via telehealth)
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged >18 years old
- Ability to take oral medication and be willing to adhere to the study regimen as described in this protocol
- Patients presenting with all types of post-concussive headache with >5/10 in severity on the numerical analog scale.
- Headache that occurs for > 4 hours per day
- Headache that occurs every day
- Headache that began after concussion, patient was diagnosed at an outpatient clinic or was hospitalized
- Headache developed within 7 days post-injury and patient presenting within 30 days from initial trauma
- A diagnosis of concussion.
- If a patient is taking another pain medication, this still be included in the stud
Exclusion Criteria13
- Any evidence of known intracranial hemorrhage on neuroimaging
- Headache developing after 7 days post injury and patient presenting after 30 days from initial trauma
- Headache occurs < 4 hours per day
- Headache does not occur daily
- Age < or = 18
- Headache is < 5 in severity on numerical analog scale
- Presence of increase in intracranial pressure or papilledema
- Any contraindication to corticosteroids
- Allergy or sensitivity to corticosteroids
- Active Tuberculosis
- Active pregnancy
- Currently on corticosteroids for another reason
- Participants with fungal infection
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Interventions
The Methylprednisolone dose pack (Medrol Dose Pack) is pre-packaged with dosing instructions. This dose pack is tapered over 7 days and administration will be the following for all patients: Day 1 (total 24 milligrams (mg)) - 8mg before breakfast, 4mg after lunch and dinner, and 8mg at bedtime Day 2 (total 20mg) - 4mg before breakfast, after lunch and dinner, and 8mg at bedtime Day 3 (total 16mg) - 4mg before breakfast, lunch, dinner, and at bedtime Day 4 (total 12mg) - 4mg before breakfast, after lunch, and at bedtime Day 5 (total 8mg) - 4mg before breakfast and at bedtime Day 6 (total 4mg) - 4mg before breakfast Day 7 (total 0mg) - Completed
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT04685772