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临床试验/NL-OMON50815
NL-OMON50815招募中不适用

Spinal Cord Stimulation for intractable chronic lower abdominal neuropathic pain caused by endometriosis - Spinal Cord Stimulation for Endometriosis pain

Academisch Medisch Centrum0 个研究点目标入组 15 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
招募中
入组人数
15

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

  • - Patients with endometriosis/ adenomyosis confirmed at surgery and without
  • options for further surgical treatment.
  • - Premenopausal woman aged >= 18 years
  • - Patients with at least one of the endometriosis related pain symptoms:
  • dysmenorrhea, pelvic pain or dyspareunia.
  • - Mean pain NRS of at least 5 (scale 0-10).
  • - The pain complaints are therapy resistant (including hormonal, medical
  • and/or surgical options)
  • - Refractory pain; Before neuromodulation patient has tried: Paracetamol,
  • NSAIDs, Anti neuropathic pain therapy, TENS
  • - Neurologic exam without marked motor deficit.
  • - Meets all the inclusion criteria for the implantation of a neurostimulation
  • system as typically utilized in the study center.
  • - 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

排除标准

  • - Female subject of childbearing potential is pregnant/nursing or plans to
  • become pregnant during the course of the study
  • - The presence of any malignancy
  • - BMI >=35
  • - Subject currently has an active implantable device including ICD, pacemaker,
  • spinal cord stimulator or intrathecal drug pump
  • - Subject is unable to operate the device
  • - Previous Neurostimulation therapy

研究者

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