A Randomised Sham-controlled Double-blinded Study of Burst Spinal Cord Stimulation for Chronic Peripheral Neuropathic Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Usual pain intensity in lower extremity(ies)
研究概览
简要总结
This study will evaluate the effect of Burst spinal cord stimulation (SCS) in the treatment of painful radiculopathy in lower extremity(ies) with or without lower back pain. It is a multicenter double-blinded "n-of-1" RCT with repeated two-week periods of Burst SCS or sham in randomised order.
详细描述
SCS is a treatment offered to patients with peripheral neuropathic pain, and involves electrical stimulation of the spinal cord. The analgesic effect is possibly mediated via both spinal and supra-spinal mechanisms.
Traditional "tonic" SCS causes paresthesia during treatment, but the newer burst technique (five electrical pulses at 500Hz delivered in intermittent packets of 40 Hz) can be performed below detection level. Thus, it is possible to do double-blinded sham-controlled studies.
In this study, we will study the effect of burst SCS compared with sham on pain intensity and function (Patient-Specific Functional Scale). In addition, we will use several questionnaires (psychometric data, health-related quality of life, sleep, global impression of change, use of analgesics, blinding).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History, symptoms and clinical findings consistent with painful radiculopathy in lower extremity(ies) ("probable" or "definite") for at least 3 months, with or without lower back pain. The pain in the extremity(ies) must dominate.
- •Understand Norwegian or Swedish language (written and spoken).
- •Usual pain intensity ≥ 3.5 / 10 (NRS 0-10)
排除标准
- •Opioid dose > 100 mg morphine equivalents / day
- •Ongoing litigation
- •Mental / psychiatric disorder that may affect treatment
- •Chronic generalized pain
- •Pregnancy
- •Hypersensitivity to local anesthetics
- •Serious or unclear medical condition such as angina pectoris, severe vascular disorder, infection, malignancy disease, bleeding disorders
- •Laminectomy in or above level for planned epidural access
- •Spine surgery the last 3 months
- •Ongoing medication that affects coagulation or platelet function
结局指标
主要结局
Usual pain intensity in lower extremity(ies)
时间窗: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period)
Numeric rating scale (0-10); usual pain intensity over the last 24 h (day 7-13) with anchor points 0 = No pain and 10 = Worst imaginable pain.
次要结局
- Insomnia(Time Frame: Will be measured at the end of each 14-day treatment period)
- EQ-5D index values(Time Frame: Will be measured at the end of each 14-day treatment period)
- EQ-5D self-rated health(Time Frame: Will be measured at the end of each 14-day treatment period)
- Three individually chosen functions that are inhibited by the pain(Time Frame: Will be measured at day 7 to day 13 in each 14-day treatment period (to avoid carry-over effects from previous treatment period))
- Patient impression of change(Time Frame: Will be measured at the end of each 14-day treatment period)
- Pain intensity in lower extremity(ies)"now"(Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
- Synptoms of anxiety and depression(Time Frame: Will be measured at the end of each 14-day treatment period)
- Patient blinding questionnaire(Time Frame: Will be measured at the end of each 14-day treatment period)
- Highest pain intensity in lower extremity(ies)(Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
- Lowest pain intensity in lower extremity(ies)(Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
- Pain unpleasantness(Time Frame: Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
- Usual pain intensity in lower back(Will be measured at day 7 to day 13 in each period (to avoid carry-over effects from previous treatment period))
研究者
Bård Lundeland
Principal Investigator
Oslo University Hospital