Reason to doubt the ICHD-3 7-day inclusion criterion for mild TBI-related posttraumatic headache: A nested cohort study.

BACKGROUND: Posttraumatic headache is difficult to define and there is debate about the specificity of the 7-day headache onset criterion in the current definition. There is limited evidence available to guide decision making about this criterion. METHOD: A nested cohort study of 193 treatment-seeking veterans who met criteria for persistent headache attributed to mild traumatic injury to the head, including some veterans with delayed headache onset up to 90 days post-injury, was undertaken. Survival analysis examined the proportion of participants reporting headache over time and differences in these proportions based on sex, headache phenotype, and mechanism of injury. RESULT: 127 participants (66%; 95% CI: 59-72%) reported headache onset within 7 days of head injury and 65 (34%) reported headache onset between 8 days and 3 months after head injury. Fourteen percent of participants reported pre-existing migraine before head injury, and there was no difference in the proportion of veterans with pre-existing migraine based on headache onset. Headache onset times were not associated with sex, headache phenotype, or mechanism of injury. There were no significant differences in proportion of veterans with headache onset within 7 days of head injury based on headache phenotype (70% migraine onset within 7 days, 70% tension-type headache within 7 days, 56% cluster headache within 7 days; p ≥ .364). Similar findings were observed for head injury (64% blast, 60% blunt; p = .973). There were no significant differences observed between headache onset groups for psychiatric symptoms (Posttraumatic Stress Disorder Checklist for DSM-5 = 1.3, 95% CI = -27.5, 30.1; Patient Health Questionnaire-9 Item = 3.5, 95% CI = -6.3, 3.7; Generalized Anxiety Disorder Screener = 6.5, 95% CI = -2.7, 15.6). CONCLUSIONS: Although most of the sample reported headache onset within 7 days of head injury, one-third experienced an onset outside of the diagnostic range. Additionally, veterans with headache onset within 7 days of head injury were not meaningfully different from those with later onset based on sex, headache phenotype, or mechanism of head injury. The ICHD-3 diagnostic criteria for 7-day headache onset should be expanded to 3 months. CLINICALTRIALS.GOV IDENTIFIER: NCT02419131.

VA/DoD Clinical Practice Guideline: Diagnosis and Treatment of Low Back Pain.

DESCRIPTION: In September 2017, the U.S. Department of Veterans Affairs (VA) and U.S. Department of Defense (DoD) approved the joint Clinical Practice Guideline (CPG) for Diagnosis and Management of Low Back Pain. This CPG was intended to provide healthcare providers a framework by which to evaluate, treat, and manage patients with low back pain (LBP). METHODS: The VA/DoD Evidence-Based Practice Work Group convened a joint VA/DoD guideline development effort that included a multidisciplinary panel of practicing clinician stakeholders and conformed to the Institute of Medicine's tenets for trustworthy clinical practice guidelines. The guideline panel developed key questions in collaboration with the ECRI Institute, which systematically searched and evaluated the literature through September 2016, developed an algorithm, and rated recommendations by using the GRADE (Grading of Recommendations Assessment, Development and Evaluation) system. A patient focus group was also convened to ensure patient values and perspectives were considered when formulating preferences and shared decision making in the guideline. RECOMMENDATIONS: The VA/DOD LBP CPG provides evidence-based recommendations for the diagnostic approach, education and self-care, non-pharmacologic and non-invasive therapy, pharmacologic therapy, dietary supplements, non-surgical invasive therapy, and team approach to treatment of low back pain.

Botulinum Toxin Type A for the Treatment of Post-traumatic Headache: A Randomized, Placebo-Controlled, Cross-over Study.

INTRODUCTION: Botulinum toxin type A (BoNT/A) is an approved treatment for chronic migraine and has been shown to be effective in reducing number, days, and severity of headache in other headache disorders. Whether botulinum toxin is a safe and effective treatment specifically for post-traumatic headache (PTH), however, is unknown. This study sought to determine whether treatment with BoNT/A improved symptoms of PTH in military veterans. MATERIALS AND METHODS: Forty subjects with PTH were randomized to receive treatment of either BoNT/A or a saline placebo. Sixteen weeks post-treatment or at return to baseline headache severity, subjects were crossed over to receive treatment with the other medication than previously treated with in the first session. Subjects recorded number of headaches, number of headache days, and headache pain severity in daily diaries. Outcome measures included change in the weekly number of headaches, number of headache days per week, and headache pain severity compared to baseline, and the change in number of headaches and number of headaches days at baseline compared to the rating scores averaged across weeks 6-11. RESULTS: The number of headaches per week significantly decreased by 2.24 (43.3%) with BoNT/A treatment (P < .001) and significantly increased by 1.28 (35.1%) with placebo (P = .02) at the end of the 16 weeks and the difference between groups was also significant (P < .001). The number of headache days per week also significantly decreased by 2.24 (44.4%) at the end of 16 weeks with BoNT/A treatment (P < .001), was not significantly changed with placebo, and the difference between the two groups was significant (P < .001). Both the change in number of headaches and number of headache days averaged across weeks 6-11 compared to baseline were significantly decreased in the BoNT/A group (1.6 and 1.4, respectively) compared to a significant increase of 0.3 in number of weekly headaches and a nonsignificant decrease of 0.1 in number of headache days for the placebo group (P = .048 and P = .005, respectively). Headache pain severity was significantly reduced by 0.06 with botulinum toxin treatment (P = .02) and was not significantly increased by 0.04 in the placebo group with a significant difference between groups (P = .006). CONCLUSIONS: Treatment with BoNT/A clinically and significantly improved the frequency and pain severity of PTH compared to placebo in military veterans. Limitations of the study include subject dropout, adherence to documenting variables daily in the dairy, and only one treatment of BoNT/A. Strengths include the cross-over study design, which demonstrated that BoNT/A was effective regardless of treatment order. This dataset is the first prospective study to evaluate BoNT/A as an intervention for symptoms of PTH and provides evidence that larger-scale and multiple treatment studies evaluating BoNT/A for this headache type are warranted.

Totally Implantable IV Treprostinil Therapy in Pulmonary Hypertension Assessment of the Implantation Procedure.

BACKGROUND: Prostacyclins improve symptoms and survival in pulmonary arterial hypertension (PAH). In response to risks associated with external delivery systems, an implantable IV infusion system was developed. A multicenter, prospective, single-arm, clinical trial (DelIVery for PAH) was conducted to evaluate this system for treprostinil in PAH. This analysis describes the findings related to the implant procedure. METHODS: Patients (N = 64) with PAH (World Health Organization group 1) receiving stable IV treprostinil were enrolled. Patients were transitioned to a temporary peripheral IV infusion catheter prior to the procedure. System implantation was performed at 10 centers under general anesthesia or deep IV sedation by clinicians from various specialties. Central venous access was via the cephalic, subclavian, jugular, or axillary vein. Using an introducer and fluoroscopic guidance, the distal tip of the infusion catheter was placed at the superior caval-atrial junction. The catheter was tunneled from the venous access site to an abdominal subcutaneous pocket, where the pump was placed. RESULTS: Of the 64 patients enrolled, four exited prior to implantation. All 60 implant procedures were successful. At baseline, all patients were receiving treprostinil via an external pump at a mean dose of 71.4 ± 27.8 ng/kg/min (range: 22-142 ng/kg/min). The implant averaged 102 ± 32 min (range: 47-184 min). Clinically significant implant procedure-related complications included one pneumothorax, two infections, and one episode of atrial fibrillation. There were three postimplantation catheter dislocations in two patients. Common implant-related events that were not complications included implant site pain (83%) and bruising (17%). CONCLUSIONS: The procedure for inserting a fully implantable system for treprostinil was successfully performed, with few complications. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01321073; URL: www.clinicaltrials.gov.