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
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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