This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache

A significant proportion of headaches occur following head trauma, and therefore are referred to as post-traumatic headaches (PTH). Traumatic brain injury (TBI) is highly prevalent in the Operation Iraqi Freedom/Operation Enduring Freedom (OIF/OEF) population and consequently there has been a rise in PTH in the clinical setting at VA hospitals. Botulinum toxin type A (BoNT-A) has been shown to be effective in treating chronic migraine and chronic daily headache. It is therefore reasonable to predict that BoNT-A may also be effective in treating PTH. This study proposes that PTH and its associated symptoms may respond positively to BoNT-A treatment due to its similar pathophysiology and clinical resemblance to other headache disorders including tension type headache, typical migraine with or without aura, and chronic daily headache.

Study Design: Veterans with mild, moderate or severe brain injury with a headache developing within 7 days after head trauma and persisting greater than 3 months were recruited from the Veterans Affairs Greater Los Angeles Healthcare System. The study is a prospective, double-blind, randomized, placebo-controlled, cross-over trial.

Inclusion Criteria:

• male or female
• age 18-65
• meets International Classification Headache Disorders II (ICHD-II) criteria for post-traumatic headache
• average pain score of greater than 4/10 in severity on the numerical rating system
• Rancho Los Amigos cognitive scale score greater than seven.

Exclusion Criteria:

• Uncontrolled medical condition other than PTH
• Severe additional chronic pain complaint which could not be distinguished from headache pain
• pregnancy, breast feeding,
• prior treatment with botulinum toxin within one year of enrollment
• current substance abuse/dependence
• medical condition that would increase risk of neuromuscular junction blockade with botulinum toxin (myasthenia gravis, Eaton Lambert, amyotrophic lateral sclerosis)
• poorly controlled psychiatric
• initiation of a new anti-depressant or anti-seizure medication within three months of enrolling in study
• ongoing disability or litigation claim.

A de-identified dataset may be provided upon request

Starting at 3 months following publication and up to 3 years after publication

Data access requests will be reviewed and requestors will sign a data access agreement

The project statistician used a computer-based random number generator to create a randomized treatment allocation schedule that was provided to the pharmacist and nurse practitioner who did not disclose this information. The pharmacist provided the nurse practitioner with the medication in an unlabeled bag, which either included BoNT-A or Normal Saline. Patients were randomized to receive BoNT-A or Normal Saline as first injection. The nurse practitioner reconstituted the medication in a separate room and then provided the investigator with unlabeled syringes.