A Prospective Controlled Treatment Trial for Post-Traumatic Headaches

Description

Post-traumatic headaches (PTH) are the most common complaint after traumatic brain injury, possibly generated by a number of stressors to the trigeminovascular and cervical plexus networks, including inflammation of the high cervical facet joints, traumatic cranial neuralgias, migraines, and myofascial injuries. To date, no treatment guidelines exist for PTH management except for conservative modalities, such as cognitive rest, physical therapy, and neuropathic pain medications, all of which have minimal evidence to support them. The investigators propose a randomized, controlled, clinical trial and prospective follow-up study to evaluate the effect of invasive procedures such as occipital nerve block (ONB) and cervical medial branch block (CMBB) in the management of PTH. Adolescents and young adults (14-35 years of age) will be recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache clinics.

Study Start Date

October, 01 2017

Estimated Completion Date

December 2018

Interventions

  • Drug: Occipital Nerve Block (ONB) using lidocaine and dexamethosone
  • Drug: Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone

Study ID

Boston Children’s Hospital -- IRB-P00025021

Status

Recruiting

Trial ID

NCT03007420

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

63

Sponsor

Boston Children’s Hospital

Inclusion Criteria

  • Age 14
  • 35 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.

Exclusion Criteria

  • Significant underlying psychological concerns, as determined by study psychologist up on review of standardized assessment
  • Lack of parental consent and child assent (if patient age <18 years) or lack of consent (if patient age >18 years). Unable to complete the questionnaire, based on parental or patient estimation of cognitive or language limitations

Gender

All

Ages

14 Years to 35 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (8)

Study Location Distance Name Phone Email
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alexandra Stillman MD None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alexandra Stillman MD None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alexandra Stillman MD None None
Beth Israel Deaconess Medical Center - Boston, Massachusetts 2.4 miles Alexandra Stillman MD None None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Kimberly Lobo MPH 857-218-3556 None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Kimberly Lobo MPH 857-218-3556 None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Kimberly Lobo MPH 857-218-3556 None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Kimberly Lobo MPH 857-218-3556 None

ClinicalTrialsLocator.com provides clinical trial listings in an easy to view format. All clinical trial information is pulled directly from ClinicalTrials.gov. This website does not guarantee acceptance into any clinical trial, and is not responsible for adverse events that may be incurred from a clinical trial.