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

Official title

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

Overview

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.

Detailed description

To the best of the investigators' knowledge, this is a novel study. Studies have been previously done on individuals who have suffered an acute TBI and were admitted to an intensive care unit (ICU) setting but none have been completed on individuals who suffer post-concussion headaches. Despite a high prevalence of post-concussive headache, there are no evidence-based guidelines for acute or preventive pharmacological treatment. Patients who experience very frequent or daily headache post-concussive headache are also at risk of developing medication-overuse headache (MOH)12. In addition, patients with post-concussive headache experience disabling comorbidities such as symptoms of depression, anxiety, and sleep disturbances 12 This study will be of benefit to patients who suffer headaches after a concussion because, though various treatments have been studied, including a combination of Reglan and Benadryl (63% effective in one prospective study) triptans vs non-triptans (70% effective vs 42% effective in one retrospective trial), gabapentin vs tricyclic antidepressants vs. no medication (no significant difference in outcome), none have been established as a definitive treatment regimen for post-concussive headache 12. Corticosteroids are currently utilized for management of these headaches; they are done so at the discretion of the physician and like the aforementioned medications, are not standard of care. Corticosteroid used in severe TBI (GCS \< 8) have been widely studied8, however the utility has not been conclusive. Of note, case studies in the pediatric population with mild TBI (GCS 13-15) and post-concussive headache, report that they respond well to the Medrol Dose Pack with headache improvement during or after completion of the medication2. Currently, there is no standard treatment of post-concussion headaches, and in clinical practice, it has been observed that only approximately 50% of patients improve without any medication use. It is important to establish the role of corticosteroids in treating post-concussive headaches because they may improve quality of life and accelerate patient's functional recovery.

Interventions

• Drug Methylprednisolone
  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, af

Primary outcome measures

• Change in headaches [Time frame: 1 Week]

Secondary outcome measures (3)

• Change in total Post Concussion Symptom (0-120) scores over time [Time frame: 12 weeks]
• EQ-5D (Euro Qual Health State Questionnaire) score changes (1-100 in each category); higher score indicates better state of health in several domains. [Time frame: 12 weeks]
• Diary of other medication use and pain level [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

United States · 1 center

• Northwell Health - North Shore University Hospital — Manhasset

Publications

• Bulamu NB, Kaambwa B, Ratcliffe J. A systematic review of instruments for measuring outcomes in economic evaluation within aged care. Health Qual Life Outcomes. 2015 Nov 9;13:179. doi: 10.1186/s12955-015-0372-8. PMID 26553129
• Bramley H, Hong J, Zacko C, Royer C, Silvis M. Mild Traumatic Brain Injury and Post-concussion Syndrome: Treatment and Related Sequela for Persistent Symptomatic Disease. Sports Med Arthrosc Rev. 2016 Sep;24(3):123-9. doi: 10.1097/JSA.0000000000000111. PMID 27482778
• Bramley H, Melinosky C, Silvis M, Ross S. Pediatric posttraumatic headache: two cases using steroids as abortive therapy. Pediatr Emerg Care. 2012 Oct;28(10):1081-4. doi: 10.1097/PEC.0b013e31826ceeeb. PMID 23034499
• Cushman DM, Borowski L, Hansen C, Hendrick J, Bushman T, Teramoto M. Gabapentin and Tricyclics in the Treatment of Post-Concussive Headache, a Retrospective Cohort Study. Headache. 2019 Mar;59(3):371-382. doi: 10.1111/head.13451. Epub 2018 Nov 19. PMID 30451286
• Ducic I, Sinkin JC, Crutchfield KE. Interdisciplinary treatment of post-concussion and post-traumatic headaches. Microsurgery. 2015 Nov;35(8):603-7. doi: 10.1002/micr.22503. Epub 2015 Sep 26. PMID 26409037
• EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9. PMID 10109801
• Halstead ME. Pharmacologic Therapies for Pediatric Concussions. Sports Health. 2016 Jan-Feb;8(1):50-2. doi: 10.1177/1941738115622158. PMID 26660460
• Hoshide R, Cheung V, Marshall L, Kasper E, Chen CC. Do corticosteroids play a role in the management of traumatic brain injury? Surg Neurol Int. 2016 Sep 13;7:84. doi: 10.4103/2152-7806.190439. eCollection 2016. PMID 27656315

Identifiers

NCT: NCT04685772 · 20-1092

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗