Cerebral PET Patterns, Inflammatory Biomarkers and Outcome in Patients Treated With Burst Spinal Cord Stimulation for Chronic Low Back and Leg Pain: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET)
研究概览
简要总结
The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).
详细描述
Background and rationale:
Tonic spinal cord stimulation for chronic primarily neuropathic pain har been used for over 50 years. Tonic stimulation in frequencies from 20 to 70 Hz produces analgesia and paresthesia in the targeted area.
Burst stimulation, a novel spinal cord stimulation pattern, is an intermittent high frequency parenthesis-free therapy. This stimulation pattern consist of 5 spikes with an inter-spike frequency of 500 Hz, delivered at 40 Hz.
Clinical effectiveness and noninferiority of Burst stimulation has been proved. A few studies suggest that Burst stimulation induce different activities in cerebral pathways, compared with tonic stimulation. Patient reported attention to pain assessed by the pain vigilance and awareness questionnaire (PVAQ) seems to differ between burst and tonic spinal cord stimulation. This trial is designed to investigate cerebral mechanisms of burst stimulation, using PET O15-water measured blood flow and tissue perfusion as a proxy for cerebral activity.
Key events in study implementation:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The stimulation periods with sham stimulation and burst are blinded to all included in the study except SCS nurse 1 who program and reset IPG during study phase 2.
Sham stimulation is achieved by switching of the stimulation equipment in connection with programming prior to the start of the current stimulation period. The programming procedure is identical before burst and sham stimulation periods.
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Occurrence of chronic pain in the lumbosacral region, as well as unilateral or bilateral leg pain.
- •Prior lumbar surgery in medical history.
- •Diagnosed with neuropathic pain in the lower extremities and graded as probable neuropathic pain or definite neuropathic pain according International Association for the Study of Pain (IASP) criteria.
- •Patient report largely unchanged pain condition last 6 months.
- •Patient has undergone a 7 day SCS trial with epidural burst stimulation with the following results:
- •At least 75% coverage of the painful area of tonic stimulation before start of burst trial stimulation.
- •At least 50% reduction in pain intensity, measured via BPI, item 5 from baseline of trial to end of trial period.
- •The patient is ≥ 18 years of age and < 60 years of age.
- •The patient must willingly participate in all parts of the study, as well as having the ability to complete the entire study plan.
- •Patient must certify that he / she understands the study plan, as well as voluntarily sign informed consent to participate in the study.
- •Must be able to sit still for a minimum of 45 minutes and be able to follow restrictions related to the PET survey.
排除标准
- •The patient has other current pain conditions than back and leg pain after back surgery.
- •The patient is treated with opioids exceeding 80 milligrams of Morphine per day or is considered at risk for development of problematic opioid use.
- •The patient suffers from an untreated depression or anxiety.
- •The patient can not complete the study plan.
- •The patient is unable to read or write Swedish.
- •The patient is currently participates in another clinical trial.
- •A history of previous PET scan or other substantial radiation dose in the last 5 years.
- •The patients is suffering from claustrophobia.
- •Ongoing pregnancy or planned pregnancy during study time.
- •The patient has contraindications for arterial catheterization.
- •The patient is previously treated with spinal cord stimulation.
结局指标
主要结局
Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET)
时间窗: PET is performed at study day 0 (baseline), day 14 and day 35.
35 Volume of Interest (VOI) will be applied to each PET scan using the PVElab software. Cerebral blood flow (CBF) and perfusable tissue fraction (PTF) will be calculated for each VOI at each scan. Same tests will be done at voxel level with the Statistical Parameter Mapping Software (SPM12), to identify areas with changed CBF or PTF that do not correspond to VOI in the template.
次要结局
- Semiquantitative assessment of protein levels associated with inflammation.(Measured at day 0 (baseline), day 14, day 21 and day 35.)
- General pain(Measured at day 0 (baseline), day 14 and day 35.)
- Disability(Measured at day 0 (baseline), day 14 and day 35.)
- Pain Vigilance and Awareness(Measured at day 0 (baseline), day 14 and day 35.)
- Global Impression of Change(Measured at day 14 and day 35.)
- Depression(Measured at day 0 (baseline), day 14 and day 35.)
- Back and leg pain(Measured at visit day 0 (baseline), day 14 and day 35.)
- Pain Catastrophizing(Measured at day 0 (baseline), day 14 and day 35.)
- Pain inference(Measured at day 0 (baseline), day 14 and day 35.)
- Anxiety(Measured at day 0 (baseline), day 14 and day 35.)