A Prospective Controlled Treatment Trial for Post-Traumatic Headaches



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:14 - 35
Updated:2/24/2018
Start Date:January 2, 2018
End Date:December 2018
Contact:Alyssa Lebel, MD
Email:Alyssa.Lebel@childrens.harvard.edu
Phone:617-355-7040

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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.

Headaches and neck pain following a concussion are potentially treatable and resolve over
time. Nerve blockade may enhance the recovery of appropriate neural circuits involved in the
pathophysiology of a chronic headache. Currently, no evidence-based guidelines exist for
treatment of PTH. Adoption of "brain rest" for 1-2 weeks, followed by gradual return to
activity and avoiding "second-impact syndrome" are current practice. The use of medications
controlling neuropathic pain is of partial benefit for some. Adverse effects like sedation,
mood changes, cardiac side effects of pharmacologic agents are often not compatible with the
demands of athletics. For those patients where sports performance is paramount, they may
therefore not be able to tolerate regular medications. The incidence of chronic
post-concussive headaches (> 3 months) at one year is 8.4% - 35% and at four years is up to
25%. Therefore, patients can have a significant disability from their post-traumatic
headaches for many years after their injury. Without appropriate treatment, these headaches
can remain as chronic headaches. Over-the-counter and other symptomatic medication overuse
can exacerbate and prolong PTH significantly, secondary to rebound headaches. Successful
treatment is essential since PTH limits return to sports as well as more general activities
of living, such as work and school. Most interventions currently in use partially help and
take several weeks to months for a noticeable benefit. PTH interventions, including ONB and
CMBB, are employed in the treatment of primary headache disorders and neck pain from cervical
arthritis and may provide more improved, faster and more sustained pain relief in many
patients. Also, given that most of the action of the nerve blocks is local, there are
significantly fewer side effects than in more standard headache medications. Injections that
use corticosteroids may be beneficial in a post-traumatic headache by reducing inflammation
and therefore mechanical allodynia. Injection of corticosteroids in the cervical facet joint
area has shown up to 13 months of pain relief. This prolonged effect may be secondary to
central pain modulation. Ultimately, nerve blocks may be a more effective and efficient
post-traumatic headache given the onset of effect and the minimal side effects.

To date, there have been no prospective studies of procedural treatments for medically
refractory PTH and none in the adolescent and young adult population in whom football
injuries are common. Despite the frequent clinical practice of using ONB and CMBB for
occipital neuralgia, cervical arthritis, and cervicogenic headaches, there has been no
adequate scientific investigation into the use of these interventions for PTH. Given that PTH
is typically felt to be secondary to an inflammatory reaction to trauma, the use of injection
of corticosteroids may be more effective in PTH than in common headache disorders.

The investigators propose a randomized, prospective, controlled treatment trial to evaluate
the efficacy of minimally invasive nerve block interventions (ONB and CMBB) as treatments for
PTH and neck pain in adolescents and adults aged 14-35 years of age with PTH.

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
We found this trial at
2
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Phone: 857-218-3556
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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