National Spine and Pain Centers, Colts Neck, NJ.
Spine (Phila Pa 1976). 2017 Jul 15;42 Suppl 14:S93-S97. doi: 10.1097/BRS.0000000000002201.
A review of the literature evaluating clinical trials of chronic back pain.
To assist physicians in assessing the quality of clinical trial data to make the most informed treatment decisions.
Chronic pain is a tremendous public health issue, affecting close to 100 million adults in the United States, and costs the American people billions of dollars. One traditional treatment approach, the long-term use of opiate medications, has recently come under intense scrutiny for problems with complications, diversion, abuse, addiction, and lack of efficacy. In addition, the Centers for Disease Control and Prevention has recognized that overprescribing opiates has enabled an overdose crisis, and written guidelines that are intended to limit their use. It is for this reason that physicians must have a comprehensive understanding of the range of drug-free alternative therapies available and have the tools needed to rigorously evaluate the chronic pain literature so they can make appropriate treatment decisions.
An evaluation of how clinical trials are designed and ranked, outcome measures, and costs for a variety of therapies is necessary to determine which treatment option is the most efficacious for an individual patient.
Clinical trial data demonstrate that spinal cord stimulation (SCS) is a safe and effective treatment option for many types of chronic pain, including back pain. The last 10 years has brought tremendous advances in the field of neuromodulation. Today, several treatment modalities exist for SCS requiring the physician to be able to critically evaluate and interpret the literature and determine which modality has the strongest evidence. When evaluating clinical trial data of patients with chronic back pain, emphasis must be placed on well designed, randomized controlled trials with long-term follow-up producing level I evidence. These data are obtained in a rigorous manner and are likely to have less bias when compared with lower level studies.
The level I studies performed to date have provided evidence that treatment with SCS results in sustainable pain reduction and improvements in scores measuring quality of life and patient functioning in those patients with chronic intractable back pain.
对评估慢性背痛临床试验的文献进行综述。
帮助医生评估临床试验数据的质量，以便做出最明智的治疗决策。
慢性疼痛是一个巨大的公共卫生问题，影响了近 1 亿美国成年人，耗费了美国人数十亿美元。一种传统的治疗方法是长期使用阿片类药物，但最近由于并发症、滥用、成瘾和缺乏疗效等问题而受到严格审查。此外，疾病控制与预防中心已经认识到，阿片类药物的过度处方导致了过量危机，并制定了旨在限制其使用的指导方针。正是出于这个原因，医生必须全面了解可供选择的无药物替代疗法，并拥有必要的工具来严格评估慢性疼痛文献，以便能够做出适当的治疗决策。
评估各种疗法的临床试验设计和排名、结果测量和成本，以确定哪种治疗方案对个体患者最有效。
临床试验数据表明，脊髓刺激（SCS）是治疗多种慢性疼痛（包括背痛）的安全有效治疗选择。过去 10 年，神经调节领域取得了巨大进展。如今，SCS 有几种治疗方式，这要求医生能够批判性地评估和解释文献，并确定哪种方式具有最强的证据。评估慢性背痛患者的临床试验数据时，必须强调设计良好、随机对照试验，并且需要长期随访，以提供一级证据。这些数据是通过严格的方式获得的，与较低水平的研究相比，可能具有更少的偏差。
迄今为止进行的一级研究提供了证据，表明 SCS 治疗可导致慢性难治性背痛患者的疼痛持续减轻，并改善生活质量和患者功能的评分。
5 级。
