A Prospective Controlled Treatment Trial for Post-Traumatic Headaches
Principal Investigator: Pradeep Dinakar, MD, MS, MBA
Collaborators: Charles Berde, MD, PhD, Joseph Cravero, MD, Alyssa Lebel, MD, Christine Madariaga, Alexandra Stillman, MD, William Meehan, MD
Research Staff: Yanira Posadas, MPH, Kimberly Lobo, MPH, Carolina Donado, MD, MBI (Boston Children’s); Stephanie Changeau, NP, Tina Arani, BA, Sc (Beth Israel Deaconess Medical Center); Lyba Khan, BA (Mass General Brigham)
What is the purpose of this study?
This study is a combined Harvard study between Boston Children’s, Beth Israel Deaconess Medical Center, and Mass General Brigham to examine the effect of minimally invasive nerve block injections in the management of post-traumatic (concussion) headaches in adolescents and young adults. The study compares the outcomes reported with each of the procedures regarding efficacy in relieving pain and possible risks and side effects.
What does the study involve?
In this study, patients will be randomized to receive either an occipital nerve block (ONB) or a cervical facet injection/medial branch block (CMBB), with the possibility of a crossover to the other treatment option in the protocol.
This study involves two in-person visits and serial email or teleconference follow-ups, for a total of seven to eight visits, lasting 12 months.
Who is eligible?
Patients who meet the criteria below will be recruited from Boston Children’s, Beth Israel Deaconess Medical Center, and Brigham and Women’s Hospital pain, concussion, and headache clinics:
- age 14 to 45 years
- history of post-traumatic headache or neck pain following a concussion or head injury within the last 12 months
- self-reported lack of meaningful benefit with at least one previous treatment trial. Previous treatment could include a migraine prophylactic medication, a neuropathic pain medication, a physical intervention, or a cognitive-behavioral intervention.
Patients’ time and effort are appreciated, and they receive a token of gratitude for completing the study. The reimbursement is given in the form of a ClinCard Mastercard, which is a reloadable debit card. The total possible reimbursement for participation in this research study is up to $150.
Where can I get more information?
Interested? Please call one of our study sites:
Boston Children’s: 617-919-6143
Beth Israel Deaconess Medical Center: 617-651-0816
Mass General Brigham: 617-732-9816
If you have general questions about this research, you can contact the principal investigator, Dr. Dinakar, or our research contacts, Yanira Posadas or Kimberly Lobo, at 617-919-6143 or 617-355-7040. Email paininterventionalresearch@childrens.harvard.edu for more details.