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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04685772
• Other study ID #: 20-1092
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: June 1, 2024

Study information

• Verified date: May 2023
• Source: Northwell Health
• Contact: Jamie Ullman, MD
• Phone: (516) 562 4300
• Email: Jullman1[@]northwell.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Provision of signed and dated informed consent form (in person or via telehealth)

2. Stated willingness to comply with all study procedures and availability for the duration of the study

3. Male or female, aged >18 years old

4. Ability to take oral medication and be willing to adhere to the study regimen as described in this protocol

5. Patients presenting with all types of post-concussive headache with >5/10 in severity on the numerical analog scale.

6. Headache that occurs for > 4 hours per day

7. Headache that occurs every day

8. Headache that began after concussion, patient was diagnosed at an outpatient clinic or was hospitalized

9. Headache developed within 7 days post-injury and patient presenting within 30 days from initial trauma

10. A diagnosis of concussion.

11. If a patient is taking another pain medication, this still be included in the stud

Exclusion Criteria:

1. Any evidence of known intracranial hemorrhage on neuroimaging

2. Headache developing after 7 days post injury and patient presenting after 30 days from initial trauma

3. Headache occurs < 4 hours per day

4. Headache does not occur daily

5. Age < or = 18

6. Headache is < 5 in severity on numerical analog scale

7. Presence of increase in intracranial pressure or papilledema

8. Any contraindication to corticosteroids

9. Allergy or sensitivity to corticosteroids

10. Active Tuberculosis

11. Active pregnancy

12. Currently on corticosteroids for another reason

13. Participants with fungal infection

Related Conditions & MeSH terms

• Headache
• Post-Concussion Syndrome

Intervention

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, 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

Country	Name	City	State
United States	Northwell Health - North Shore University Hospital	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States, 

References & Publications (18)

Bland JM, Altman DG. Applying the right statistics: analyses of measurement studies. Ultrasound Obstet Gynecol. 2003 Jul;22(1):85-93. doi: 10.1002/uog.122. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Halstead ME. Pharmacologic Therapies for Pediatric Concussions. Sports Health. 2016 Jan-Feb;8(1):50-2. doi: 10.1177/1941738115622158. — View Citation

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. — View Citation

Kacperski J. Pharmacotherapy for Persistent Posttraumatic Headaches in Children and Adolescents: A Brief Review of the Literature. Paediatr Drugs. 2018 Oct;20(5):385-393. doi: 10.1007/s40272-018-0299-8. — View Citation

King NS, Crawford S, Wenden FJ, Moss NE, Wade DT. The Rivermead Post Concussion Symptoms Questionnaire: a measure of symptoms commonly experienced after head injury and its reliability. J Neurol. 1995 Sep;242(9):587-92. doi: 10.1007/BF00868811. — View Citation

Kuczynski A, Crawford S, Bodell L, Dewey D, Barlow KM. Characteristics of post-traumatic headaches in children following mild traumatic brain injury and their response to treatment: a prospective cohort. Dev Med Child Neurol. 2013 Jul;55(7):636-41. doi: 10.1111/dmcn.12152. Epub 2013 Apr 5. — View Citation

Larsen EL, Ashina H, Iljazi A, Al-Khazali HM, Seem K, Ashina M, Ashina S, Schytz HW. Acute and preventive pharmacological treatment of post-traumatic headache: a systematic review. J Headache Pain. 2019 Oct 21;20(1):98. doi: 10.1186/s10194-019-1051-7. — View Citation

Marshall S, Bayley M, McCullagh S, Velikonja D, Berrigan L, Ouchterlony D, Weegar K; mTBI Expert Consensus Group. Updated clinical practice guidelines for concussion/mild traumatic brain injury and persistent symptoms. Brain Inj. 2015;29(6):688-700. doi: 10.3109/02699052.2015.1004755. Epub 2015 Apr 14. — View Citation

Potter S, Leigh E, Wade D, Fleminger S. The Rivermead Post Concussion Symptoms Questionnaire: a confirmatory factor analysis. J Neurol. 2006 Dec;253(12):1603-14. doi: 10.1007/s00415-006-0275-z. Epub 2006 Oct 24. — View Citation

Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337-43. doi: 10.3109/07853890109002087. — View Citation

Seifert T. Post-Traumatic Headache Therapy in the Athlete. Curr Pain Headache Rep. 2016 Jun;20(6):41. doi: 10.1007/s11916-016-0568-6. — View Citation

Solomon S. Post-traumatic headache: commentary: an overview. Headache. 2009 Jul;49(7):1112-5. doi: 10.1111/j.1526-4610.2009.01462.x. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in headaches	Defined as change in headache in response to medication	1 Week
Secondary	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.	12 weeks
Secondary	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)	12 weeks
Secondary	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).	12 weeks

External Links

•   Medrol Dose Pack Product information