NCT02349659终止不适用
A Randomised Controlled Trial to Evaluate the Efficacy of the Spinal Modulation Axium® NeuroStimulator THerapy as a Treatment for Persistent INGuinal Pain Following Surgical Intervention: SMASHING
Maxima Medical Center1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percentage of subjects experiencing ≥50% reduction in average daily pain intensity in the Axium Group as compared to the CMM only group using an eleven point (0-10) numerical pain rating scale (NPRS)
研究概览
简要总结
24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM. Subject population is chronic inguinal pain refractory to previous surgical intervention (neurectomy).
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
- None
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
- •Subject is at least 18 years old
- •Subject is able and willing to comply with the follow-up schedule and protocol
- •Chronic inguinal pain following Pfannenstiel Incision or Open Inguinal Hernia Repair for at least 6 months
- •Previously undergone neurectomy procedure as a treatment for chronic inguinal pain
- •Minimum daily average baseline pain rating of 5 out of 10 in the inguinal area on an 11-point NPRS
- •Subject is able to provide written informed consent
- •Meets of the inclusion criteria for the implantation of a neurostimulation system as set out by the Dutch Neuromodulation Society
- •Subject has been screened by a multi-disciplinary panel including the designated psychologist of the Máxima Medical Center and deemed suitable for implantation
排除标准
- •Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the Trial
- •Escalating or changing pain condition within the past month as evidenced by investigator examination
- •Subject has had injection therapy or radiofrequency treatment of a target neural structure within the past 3 months
- •Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
- •Subject is unable to operate the device
- •Subjects currently has an active infection
- •Subject has participated in another clinical investigation within 30 days
- •Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
- •Subject has a current or on going condition, which will probably require MRI investigation sometime in the following 2 years
- •Subject has had a spinal surgical procedure at or between vertebral levels T10-L2
- •Subject has been diagnosed with cancer in the past 2 years, except for skin malignancies.
研究组 & 干预措施
Conservative Medical Management
No Intervention
Continued medical management restricted to exclude interventional pain treatments
Axium Group
Active Comparator
As the CMM group but also treated with Dorsal Root Ganglion stimulation using the Axium neurostimulator
干预措施: Implantation with the commercially available Axium neurostimulator (Device)
结局指标
主要结局
Percentage of subjects experiencing ≥50% reduction in average daily pain intensity in the Axium Group as compared to the CMM only group using an eleven point (0-10) numerical pain rating scale (NPRS)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Frederique Mol
drs.
Maxima Medical Center
研究点 (1)
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