EuroQol--a new facility for the measurement of health-related quality of life.
EuroQol Group
https://pubmed.ncbi.nlm.nih.gov/10109801/Actively Recruiting
Led by Northwell Health · Updated on 2024-11-12
25
Participants Needed
1
Research Sites
52 weeks
Total Duration
Researchers are evaluating the effectiveness of corticosteroids for treating acute post-concussion headaches. This study aims to determine if corticosteroids can reduce headache frequency and intensity more than the current standard care. It also explores whether corticosteroid use can lessen other symptoms like vestibular issues, helping patients return sooner to school, work, or sports. This novel pilot project focuses on patients with post-concussion headaches, a condition lacking established treatment guidelines despite its high prevalence and associated disabling symptoms such as depression and sleep problems. Participants will receive a Methylprednisolone dose pack, a corticosteroid medication tapered over seven days with a specific daily dosing schedule starting at 24 mg on day one and decreasing to zero by day seven. The treatment is taken orally following detailed instructions. The study does not mention a placebo or comparator group, focusing instead on evaluating this medications impact on post-concussion headaches during the treatment period. During the study, participants will be monitored over 12 weeks to assess changes in headache symptoms, overall post-concussion symptoms, quality of life through health questionnaires, and other medication use with pain tracking diaries. The primary outcome is the change in headaches one week after treatment starts. Secondary outcomes include symptom scores and quality of life measures at 12 weeks. Participants adherence to the medication regimen and symptom changes will be carefully observed to understand corticosteroids role in managing post-concussion headaches.
CONDITIONS
Assessment of the Efficacy of Medrol Dose Pack for Acute Post-Concussive Headaches
J
Jamie Ullman, MD
B
Betsy Moclair, RN, CCRC
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Northwell Health
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days
Participants take the Medrol Dose Pack, a corticosteroid medication tapered over 7 days to treat post-concussive headaches.
1 baseline visit and daily medication administration at home
Duration - 12 weeks
Participants are monitored for changes in headache symptoms and overall health for up to 12 weeks after treatment.
Periodic follow-up visits over 12 weeks
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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EuroQol Group
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https://pubmed.ncbi.nlm.nih.gov/26660460/Northwell Health
Lead Sponsor