NL-OMON44602已完成不适用
A randomized 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 Medisch Centrum0 个研究点目标入组 78 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
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 inguinal hernia repair or laparoscopic inguinal repair for at least 6 months.
- •Previously undergone neurectomy procedure as a treatment for chronic inguinal pain.
- •Minimum baseline pain rating of 6 out of 10 in the inguinal area on an 11-point NPRS.
- •Subject is able to provide written informed consent.
- •Meets 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-disciplanary panel including the designated psychologist of the Máxima Medical Centre Eindhoven and deemed suitable for implantation.
- •Neuropathic Pain as described by a score of *4 on the DN4 questionnaire
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 ICD, pacemaker, spinal cord stimulator or intrathecal drug pump.
- •Subject is unable to operate the device.
- •Subject 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 ongoing 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 had been diagnosed with cancer in the past 2 years, except for skin malignancies
- •Subject has a significant progressive peripheral or central neurological disorder such as Diabetic Polyneuropathy or Multiple Sclerosis
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