A Prospective, Single-Blinded, Dose-Response Study of SCS Therapy using Paraesthesia-Free Waveform Patterns in Patients with Chronic Neuropathic Low Back Pain
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 27
研究概览
简要总结
This study was testing if a new form of spinal cord stimulation (SCS) programming can reduce chronic neuropathic low back pain. Twenty-seven patients were implanted with a stimulator and participated in the study. On average, patients had lived with low back pain for 14 years, and the average pain score before study treatment was 72 out of 100. All patients trialed up to 3 different SCS study programs in the first 14 weeks and then selected their best program for the rest of the study. Three patients dropped out of the study due to adverse events. There were no serious adverse events related to the study treatment or procedures. After 6-months of SCS treatment, pain score was reduced by 51.7 points on average, and 77% of patients had 50% or more pain relief. After 12-months, pain score was reduced by 43.9 points on average, and 65% of patients had 50% or more pain relief. Patients also had significant improvements to quality-of-life and health survey scores. At the end of the study, 83% of patients were satisfied with their treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 o limit(—)
- 性别
- All
入选标准
- •Age 18 years or older
- •- Physician diagnosed neuropathic low back pain
- •- Candidate for trial of SCS therapy
排除标准
- •-Meets any contraindication for SCS therapy
- •-Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
