A Prospective Controlled Treatment Trial for Post-Traumatic Headaches

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 adults (14-45 years of age) will be recruited from Boston Children's Hospital and Beth Israel Deaconess Medical Center Pain clinics, Concussion clinics and Headache clinics.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston Children's Hospital; Boston Children’s Hospital
• Collaborators: Beth Israel Deaconess Medical Center; Harvard University
• Treatments: Anesthetics; Anesthetics, Local; Lidocaine

Criteria

Inclusion Criteria:

• Age 14 - 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.

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