Burchiel K J, Anderson V C, Brown F D, Fessler R G, Friedman W A, Pelofsky S, Weiner R L, Oakley J, Shatin D
Division of Neurosurgery, Oregon Health Sciences University, Portland.
Spine (Phila Pa 1976). 1996 Dec 1;21(23):2786-94. doi: 10.1097/00007632-199612010-00015.
This prospective, multicenter study was designed to investigate the efficacy and outcome of spinal cord stimulation using a variety of clinical and psychosocial outcome measures. Data were collected before implantation and at regular intervals after implantation. This report focuses on 70 patients who had undergone 1 year of follow-up treatment at the time of data analysis.
To provide a more generalizable assessment of long-term spinal cord stimulation outcome by comparing a variety of pain and functional/quality-of-life measures before and after management. This report details results after 1 year of stimulation.
The historically diverse methods, patient selection criteria, and outcome measures reported in the spinal cord stimulation literature have made interpretation and comparison of results difficult. Although short-term outcomes are generally consistent, long-term outcomes of spinal cord stimulation, as determined by prospective studies that assess multidimensional aspects of the pain complaint among a relatively homogeneous population, are not well established.
Two hundred nineteen patients were entered at six centers throughout the United States. All patients underwent a trial of stimulation before implant of the permanent system. Most were psychologically screened. One hundred eighty-two patients were implanted with a permanent stimulating system. At the time of this report, complete 1-year follow-up data were available on 70 patients, 88% of whom reported pain in the back or lower extremities. Patient evaluation of pain and functional levels was completed before implantation and 3, 6, 12, and 24 months after implantation. Complications, medication usage, and work status also were monitored.
All pain and quality-of-life measures showed statistically significant improvement during the treatment year. These included the average pain visual analogue scale, the McGill Pain Questionnaire, the Oswestry Disability Questionnaire, the Sickness Impact Profile, and the Back Depression Inventory. Overall success of the therapy was defined as at least 50% pain relief and patient assessment of the procedure as fully or partially beneficial and worthwhile. Using this definition, spinal cord stimulation successfully managed pain in 55% of patients on whom 1-year follow-up is available. Complications requiring surgical intervention were reported by 17% (12 of 70) of patients. Medication usage and work status were not changed significantly.
This prospective, multicenter study confirms that spinal cord stimulation can be an effective therapy for management of chronic low back and extremity pain. Significant improvements in many aspects of the pain condition were measured, and complications were minimal.
这项前瞻性多中心研究旨在使用多种临床和社会心理结局指标来调查脊髓刺激的疗效和结果。在植入前及植入后定期收集数据。本报告聚焦于在数据分析时已接受1年随访治疗的70例患者。
通过比较治疗前后的各种疼痛及功能/生活质量指标，对脊髓刺激的长期结果进行更具普遍性的评估。本报告详细介绍了刺激1年后的结果。
脊髓刺激文献中历来报道的方法、患者选择标准和结局指标各不相同，这使得结果的解读和比较变得困难。尽管短期结果通常较为一致，但前瞻性研究对相对同质人群中疼痛主诉的多维度方面进行评估所确定的脊髓刺激长期结果尚未明确。
在美国各地的6个中心纳入了219例患者。所有患者在植入永久性系统前均进行了刺激试验。大多数患者接受了心理筛查。182例患者植入了永久性刺激系统。在撰写本报告时，70例患者有完整的1年随访数据，其中88%报告有背部或下肢疼痛。在植入前以及植入后3、6、12和24个月完成了患者对疼痛和功能水平的评估。还监测了并发症、药物使用情况和工作状态。
在治疗的这一年中，所有疼痛和生活质量指标均显示出统计学上的显著改善。这些指标包括平均疼痛视觉模拟量表、麦吉尔疼痛问卷、奥斯维斯特残疾问卷、疾病影响概况量表和背部抑郁量表。治疗的总体成功定义为疼痛缓解至少50%，且患者认为该治疗完全或部分有益且值得。根据这一定义，在有1年随访数据的患者中，脊髓刺激成功缓解了55%患者的疼痛。17%（70例中的12例）患者报告了需要手术干预的并发症。药物使用情况和工作状态没有显著变化。
这项前瞻性多中心研究证实，脊髓刺激可有效治疗慢性腰腿痛和肢体疼痛。疼痛状况的许多方面都有显著改善，并发症极少。
