Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: a Multicenter Randomized Trial (BURST-RAP Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 12
- 主要终点
- Pain catastrophizing score
研究概览
简要总结
Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain
详细描述
This multicenter randomized clinical trial will take place in 6 Dutch hospitals: the Rijnstate Hospital (Arnhem), Bravis Hospital (Roosendaal), Elizabeth TweeSteden Hospital (Tilburg), Diakonessen Hospital (Utrecht), Alrijne Hospital (Leiden) and the Amsterdam University Medical Hospitals A-UMC). PSPS Type II2 patients (n=96) will be randomized into a group receiving either active or passive recharge burst. Following a successful trial period, patients are permanently implanted. Patients complete the pain catastrophizing score (PCS) (primary outcome at 6 months), numeric pain rating scale (NRS), patient vigilance and awareness questionnaire (PVAQ), hospital anxiety and depression scale (HADS), quality of life (EQ-5D), Oswestery disability index (ODI), patient global impression of change (PGIC) and painDETECT questionnaires (secondary outcomes) at baseline, after trial, 1, 3, 6 and 12 months following implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between 18 and 70 years of age
- •At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic.
- •Chronic pain diagnoses as PSPS Type 2 of at least 6 months
- •Neurologic exam without marked motor deficit.
- •LBP and/or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10
- •Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an
排除标准
- •Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
- •Subject is able and willing to comply with the follow-up schedule and protocol
- •Subject is able to provide written informed consent
- •Exclusion Criteria:
- •Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
- •Escalating or changing pain condition within the past month as evidenced by investigator examination
- •"Subject has had injection therapy or radiofrequency treatment for their low back pain (LBP) or leg pain within the past 3 months"
- •Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
- •Subject is unable to operate the device
- •Severe spinal column degeneration likely to cause technical problems with neuromodulation, to be assessed by the treating physician
- •Previous Neurostimulation therapy
结局指标
主要结局
Pain catastrophizing score
时间窗: 6 months
次要结局
- Mean charge per hour used(3, 6, 12 months)
- Patient vigilance and awareness questionnaire(3, 6, 12 months)
- Mean charge per second used(3, 6, 12 months)
- Hospital anxiety and depression scale(3, 6, 12 months)
- Oswestery disability index(3, 6, 12 months)
- Numeric pain rating scale(3, 6, 12 months)
- Patient global impression of change(3, 6, 12 months)
- PainDETECT questionnaire(3, 6, 12 months)
- EQ-5D questionnaire(3, 6, 12 months)