Randomized Controlled Double-blind Cross-over Trial Evaluating the Role of Frequencies on Spinal Cord Stimulation in the Management of Failed Back Surgery Syndrome (SCS Frequency Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Visual Analog Scale (VAS) on Back Pain
研究概览
简要总结
The purpose of this study is to evaluate the role of frequency settings on spinal cord stimulation in the management of Failed Back Surgery Syndrome (SCS Frequency Study).
详细描述
Prospective, single-center, double-blinded, randomized crossover of 4 different stimulation frequencies: sham, 1200 Hz, 3030 Hz, and 5882 Hz.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old at the time of informed consent
- •Willing and able to provide a signed and dated informed consent
- •Capable of comprehending and consenting in English
- •Willing and able to comply with all study procedures, study visits, and be available for the duration of the study
- •On a stable dose (no new, discontinued or changes in) of all prescribed pain medications and willing/able to maintain or only decrease the dose of all prescribed pain medications
- •Tried appropriate conventional medical management for their pain
- •Not indicated for additional surgical treatment in the opinion of the referring physician or spinal surgeon
- •Undergone previous spinal surgery
- •Diagnosed with FBSS with appropriate pain score
- •Primary pain at appropriate spinal level
排除标准
- •Has an active implanted device, whether turned on or off
- •Displays current signs of a systemic infection
- •Pregnant or lactating, inadequate birth control, or the possibility of pregnancy during the study
- •Has untreated major psychiatric comorbidity
- •Has serious drug-related behavioral issues
- •Has neurological abnormalities unrelated to Failed Back Surgery Syndrome
- •Diagnosed with Raynaud disease
- •Diagnosed with Fibromyalgia
- •Has any active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to screening
- •Has secondary gains which, in the opinion of the investigator, are likely to interfere with the study
- •Participating or planning to participate in another clinical trial
- •Has characteristics/limits of household or close contacts involved in study (eg, family member already a study participant where blind could be broken)
研究组 & 干预措施
Sham
Frequency Setting - Sham
干预措施: Sham (Device)
1200 Hz
Frequency Setting - 1200 Hz
干预措施: 1200 Hz (Device)
3030 Hz
Frequency Setting - 3030 Hz
干预措施: 3030 Hz (Device)
5882 Hz
Frequency Setting - 5882 Hz
干预措施: 5882 Hz (Device)
结局指标
主要结局
Visual Analog Scale (VAS) on Back Pain
时间窗: 12 weeks
Visual Analog Scale (VAS) back pain scores were recorded once a day on a multi-day diary, where subjects rate the pain by making a vertical slash mark through the 0-10cm line that best describes their pain during the last 24 hours, with 0 = No pain and 10 = Worst pain imaginable. The higher VAS back pain score represented worse back pain. The average VAS back pain scores from the last three days of diary prior to the follow-up visits were used for analysis.
次要结局
未报告次要终点