Multicenter Prospective Clinical Series Evaluating Radiofrequency Ablation in the Treatment of Painful Spine Metastases.

BACKGROUND: Radiofrequency ablation (RFA) of vertebral body metastases (VBM) has been reported as safe and effective in retrospective studies. This single-arm prospective multicenter clinical study evaluates RFA in the treatment of painful VBM. METHODS: Fifty patients with VBM were prospectively enrolled during a 13-month period at eight US centers under an IRB-approved study. Percutaneous RFA was performed under imaging guidance with cement augmentation at the discretion of the operator. Pain, disability and quality of life were evaluated at baseline, prior to discharge, days 3, 7, 30 and 90 using the Numerical Pain Rating Scale, Oswestry Disability Index (ODI), the Functional Assessment of Cancer Therapy-General 7 (FACT-G7) and Functional Assessment of Cancer Therapy Quality-of-Life Measurement in Patients with Bone Pain (FACT-BP). Adverse events were monitored throughout this time interval. RESULTS: Twenty-six male and 24 female patients (mean age 61.0) underwent 69 treatments (30 thoracic and 39 lumbar). Cement augmentation was performed in 96 % of reported levels. Significant improvement in mean scores for pain, disability and cancer-specific health-related quality of life from baseline to all time intervals was seen. NRPS improved from 5.9 to 2.1 (p < 0.0001). ODI improved from 52.9 to 37.0 (p < 0.08). FACT-G7 improved form 10.9 to 16.2 (p = 0.0001). FACT-BP improved from 22.6 to 38.9 (p < 0.001). No complications related to the procedure were reported. CONCLUSION: RFA with cement augmentation safely and effectively reduces pain and disability rapidly, while increasing quality of life in patients suffering from vertebral body metastases.

Percutaneous vertebroplasty for osteoporotic compression fractures: quantitative prospective evaluation of long-term outcomes.

PURPOSE: Osteoporotic vertebral compression fractures may cause debilitating pain that lasts for weeks or months, and which is often neither quickly nor completely relieved by conventional conservative therapy. Previous retrospective studies have suggested significant and nearly immediate pain relief, as well as rapid and sustained functional recovery, after percutaneous polymethylmethacrylate vertebroplasty (PPV). This prospective, quantitative study with long-term follow-up was designed to evaluate the safety and efficacy of PPV as a new treatment for patients with osteoporotic vertebral body compression fractures of the lumbar and thoracic spine. MATERIALS AND METHODS: PPV was performed in 30 patients with 54 symptomatic osteoporotic vertebral compression fractures who had a less-than-satisfactory response to conventional therapy. All procedures were performed by a single operator with significant experience in performing PPV. The Musculoskeletal Outcomes Data Evaluation and Management Scale (MODEMS) spinal intervention questionnaire, which includes the SF-36, was administered to all patients before intervention and exactly 2 weeks after the final PPV procedure. Pain and disability, treatment expectations and satisfaction, mental function, and quality of life were evaluated by four specialized modules, and responses to questionnaires preceding treatment were compared to those obtained at follow-up. Results of a long-term follow-up questionnaire were collected 15-18 months after the final vertebroplasty treatment. RESULTS: Our population consisted of three men and 27 women, with a mean age of 79 years. Fifty-four PPV procedures were performed for compression fractures in these 30 patients. Significant postprocedural improvement in all four MODEMS modules was demonstrated at 2 weeks (treatment score, P <.0001; pain and disability, P <.0001; physical function, P =.0004; and mental function, P =.0009). A small epidural leak of polymethylmethacrylate in one patient was asymptomatic and did not require intervention. At long-term follow-up (15-18 mo), 22 of 23 patients responding remained satisfied with the outcome of therapy and believed that the procedure had provided durable pain relief. Verbal pain scores documented significantly diminished back pain at 2 weeks (P <.0001) and again at long-term follow-up when compared to baseline (P <.0001). CONCLUSIONS: PPV is a safe and efficacious procedure for the relief of pain and disability after osteoporotic vertebral compression fractures. Patient satisfaction is high and persists when compared to preprocedural expectations; durable pain relief is provided.