Actively Recruiting

Age: 18Years +
All Genders
NCT04685772

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

Led by Northwell Health · Updated on 2024-11-12

25

Participants Needed

1

Research Sites

295 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form (in person or via telehealth)
  • Willingness to comply with all study procedures and be available for the study duration
  • Male or female aged over 18 years
  • Ability to take oral medication and willingness to follow the study regimen
  • Experiencing post-concussive headaches with pain severity over 5 out of 10 on the numerical scale
  • Headaches lasting more than 4 hours per day
  • Headaches occurring every day
  • Headaches began after a concussion diagnosis, either outpatient or hospitalized
  • Headaches developed within 7 days after injury and presenting within 30 days from trauma
  • Diagnosis of concussion
  • Use of other pain medications allowed during the study
Not Eligible

You will not qualify if you...

  • Evidence of intracranial hemorrhage on neuroimaging
  • Headaches starting more than 7 days after injury or presenting more than 30 days after trauma
  • Headaches lasting less than 4 hours per day
  • Headaches not occurring daily
  • Age 18 years or younger
  • Headache severity less than 5 on numerical scale
  • Signs of increased intracranial pressure or papilledema
  • Contraindication or allergy to corticosteroids
  • Active tuberculosis
  • Pregnancy
  • Current corticosteroid use for other reasons
  • Fungal infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Northwell Health - North Shore University Hospital

Manhasset, New York, United States, 11030

Actively Recruiting

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Research Team

J

Jamie Ullman, MD

CONTACT

B

Betsy Moclair, RN, CCRC

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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