Safeguards to prevent neurologic complications after epidural steroid injections: consensus opinions from a multidisciplinary working group and national organizations.

BACKGROUND: Epidural corticosteroid injections are a common treatment for radicular pain caused by intervertebral disc herniations, spinal stenosis, and other disorders. Although rare, catastrophic neurologic injuries, including stroke and spinal cord injury, have occurred with these injections. METHODS: A collaboration was undertaken between the U.S. Food and Drug Administration Safe Use Initiative, an expert multidisciplinary working group, and 13 specialty stakeholder societies. The goal of this collaboration was to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections and produce consensus procedural clinical considerations aimed at enhancing the safety of these injections. U.S. Food and Drug Administration Safe Use Initiative representatives helped convene and facilitate meetings without actively participating in the deliberations or decision-making process. RESULTS: Seventeen clinical considerations aimed at improving safety were produced by the stakeholder societies. Specific clinical considerations for performing transforaminal and interlaminar injections, including the use of nonparticulate steroid, anatomic considerations, and use of radiographic guidance are given along with the existing scientific evidence for each clinical consideration. CONCLUSION: Adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurologic injuries.

Vertebral compression fractures: pain reduction and improvement in functional mobility after percutaneous polymethylmethacrylate vertebroplasty retrospective report of 245 cases.

PURPOSE: To describe the immediate outcome of a large cohort of patients who underwent percutaneous polymethylmethacrylate (PMMA) vertebroplasty for treatment of one or more vertebral fractures. MATERIALS AND METHODS: This retrospective cohort study included seven university-based and private hospitals in the United States. Of 488 consecutive patients (mean age, 76 years) who underwent percutaneous PMMA vertebroplasty between 1996 and 1999, 245 were successfully interviewed retrospectively after vertebroplasty (median time, 7 months). Through telephone interview, patients completed our self-developed questionnaire designed to measure pain (10-point scale), ambulation (five-point scale), and ability to perform activities of daily living (ADL) (five-point scale) before and after vertebroplasty. Differences in reported pain, ambulation, and ability to perform ADL before and after vertebroplasty were evaluated with paired t tests. Differences in proportions were compared with the McNemar test. Subgroup analyses were performed to assess the consistency of differences in pre- and postprocedural pain and functional status by patient age, number of fractures, time from fracture to vertebroplasty, and time from vertebroplasty to questionnaire completion. RESULTS: On a 10-point scale, mean pain decreased from 8.9 before vertebroplasty to 3.4 afterward (P <.001). Seventy-two percent of patients had substantially impaired ambulation before vertebroplasty compared with 28% afterward (P <.001). Ability to perform ADL was also significantly improved following vertebroplasty (P <.001). Twelve patients (4.9%) experienced symptomatic complications (none major or life threatening). CONCLUSION: Treatment of vertebral fractures with percutaneous PMMA vertebroplasty appears to be safe and results in substantial immediate pain reduction and improved functional status. A randomized controlled trial appears warranted to assess the efficacy and safety of vertebroplasty.