Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: A Randomized Double-blind Sham-controlled Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- change in disease-specific functional outcome from baseline
研究概览
简要总结
Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant.
'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.
The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.
The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.
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)
盲法说明
During the 12 months following implantation of a spinal cord stimulation (SCS) system, the patients will undergo four three-month long periods with either burst SCS or no stimulation (sham) in a randomized order. All patients will undergo two periods of SCS and sham stimulation.
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
- •Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
- •Minimum pain intensity of 5/10 on the leg pain NRS at baseline
- •Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
- •Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital
- •Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
排除标准
- •Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
- •History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
- •Abnormal pain behavior and/or unresolved psychiatric illness.
- •Unresolved issues of secondary gain or inappropriate medication use.
研究组 & 干预措施
Sham SCS
Sham spinal cord stimulation. SCS system implanted but no stimulation given.
干预措施: Sham spinal cord stimulation (Procedure)
Burst SCS
Burst Spinal cord stimulation. SCS system implanted and burst stimulation given
干预措施: Burst Spinal Cord Stimulation (Procedure)
Sham SCS
Sham spinal cord stimulation. SCS system implanted but no stimulation given.
干预措施: SCS implant (Device)
Burst SCS
Burst Spinal cord stimulation. SCS system implanted and burst stimulation given
干预措施: Sham spinal cord stimulation (Procedure)
Burst SCS
Burst Spinal cord stimulation. SCS system implanted and burst stimulation given
干预措施: SCS implant (Device)
Sham SCS
Sham spinal cord stimulation. SCS system implanted but no stimulation given.
干预措施: Burst Spinal Cord Stimulation (Procedure)
结局指标
主要结局
change in disease-specific functional outcome from baseline
时间窗: 12 months
measured with version 2.0 of the Oswestry disability index (ODI) that has been translated into Norwegian and tested for psychometric properties. The ODI questionnaire quantifies disability for degenerative conditions of the lumbar spine and covers intensity of pain, ability to lift, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. The index is scored from 0 to 100. Zero means no disability and 100 reflects maximum disability.
次要结局
- change in leg pain(12 months)
- Change in generic health-related quality of life measured with the Euro-Qol-5D (5L)(12 months)
- Change in back pain(12 months)
- Daily physical activity(12 months)
- Six-month follow-up of pain-related disability(18 months)