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Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches

ConditionsPost-Concussion SyndromeHeadache
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNorthwell Health

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Patients who meet the inclusion criteria will be consented for the study. Patients will be recruited when they follow up on their initial appointment after hospitalization

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Methylprednisolone

    Drug

    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

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Change in headaches

Defined as change in headache in response to medication

Time frame
1 Week

Secondary outcomes

1

Change in total Post Concussion Symptom (0-120) scores over time

change in the NEW total PCSS score from baseline (day0) to week 1, to week 4 and to week 12; Higher scores indicate worse symptoms.

Time frame
12 weeks
2

EQ-5D (Euro Qual Health State Questionnaire) score changes (1-100 in each category); higher score indicates better state of health in several domains.

EQ-5D score in the categories of 'Usual Activities' and 'Pain/Discomfort' of the EQ-5D Health Questionnaire between visit 1 (day 7) and visit 5(week 11/12)

Time frame
12 weeks
3

Diary of other medication use and pain level

Secondary outcome 9: Each patient will be asked to keep a daily diary, recording pain medications used and a pain level (in a scale of 0-10).

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwell Health

Lead sponsor

Source ClinicalTrials.gov
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