Abobotulinumtoxina Efficacy in Post-Traumatic Headache
- Conditions
- Post-Traumatic Headache
- Interventions
- Drug: Normal saline
- Registration Number
- NCT03928496
- Lead Sponsor
- VA Greater Los Angeles Healthcare System
- Brief Summary
This study will evaluate the efficacy of abobotulinumtoxina on Veterans with post-traumatic headache
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo Normal saline 0.9% preservative free sterile saline. 0.1 ml were injected into 31 sites of the head and neck Abobotulinumtoxina AbobotulinumtoxinA 300 units of abobotulinumtoxinA was reconstituted with 2.4 ml of 0.9% preservative free sterile saline so that each 0.1 ml contained 12.5 units of Abobotulinumtoxina 0.1 ml were injected into 31 sites of the head and neck
- Primary Outcome Measures
Name Time Method Incidence of headaches from baseline evaluation from time of injection until completion of 12 week follow-up Evaluation in weekly incidence of headaches from baseline based on headache diary or weekly phone follow-up
- Secondary Outcome Measures
Name Time Method Intensity of headache pain evaluation from time of injection until completion of 12 week follow-up Evaluation of pain intensity using score of headache on Numerical Rating Scale (NRS) over time. The NRS is an 11-point scale for patient self-reporting of pain with 0 being no pain and 10 being the most severe pain.
Number of headache days per week evaluation from time of injection until completion of 12 week follow-up Evaluation of the number of days a headache was present over each week
Trial Locations
- Locations (1)
VA Greater Los Angeles Healthcare System
🇺🇸Los Angeles, California, United States