NL-OMON54983已完成4 期
Comparison of DTM SCS Therapy Combined with standard pain treatment to standard pain treatment alone in the Treatment of Intractable Back Pain Subjects without previous history of Lumbar Spine Surgery - DTM-INT 2020PM2
SGX International LLC (SGX Health Europe)0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •A subject must MEET ALL of the following inclusion criteria:
- •1. Be a candidate for SCS system (trial and implant)
- •2. Have been diagnosed with chronic, refractory axial low back pain with or
- •without lower limb pain, with a neuropathic component as assessed by the
- •investigator, 6 months refractory to conventional therapy and are not eligible
- •for spine surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy) at
- •the time of enrollment.
- •3. Has an average back pain intensity >= 6.0 cm on the 10.0 cm Visual Analog
- •Scale (VAS) at the time of enrollment
- •4. Be willing and capable of giving written informed consent to participate in
- •this clinical study based on voluntary agreement after a thorough explanation
- •of the subject*s participation has been provided.
- •5. Be willing and capable of subjective evaluation, read and understand written
- •questionnaires, and read, understand and sign the written inform consent.
- •6. Be 18 years of age or older at the time of enrollment
- •7. Be on a stable pain medication regimen, as determined by the study
- •investigator, for at least 30 days prior to enrolling in this study
- •8. Be willing and able to comply with study-related requirements, procedures,
排除标准
- •A subject must NOT MEET ANY of the following exclusion criteria:
- •1. Had previous lumbar spinal surgery (e.g., lumbar fusion, discectomy,
- •laminectomy, laminotomy)
- •2. Has a medical, anatomical, and/or psychosocial condition that is
- •contraindicated for commercially available IntellisTM SCS systems as determined
- •by the Investigator
- •3. Has a diagnosed back condition with inflammatory causes of back pain (e.g.,
- •onset of severe pain with activity), serious spinal pathology and/or
- •neurological disorders as determined by the investigator
- •4. Be concurrently participating in another clinical study
- •5. Has an existing active implanted device such as a pacemaker, another SCS
- •unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
- •6. Has a pain in other area(s) and/or medical condition requiring the regular
- •use of significant pain medications that could interfere with accurate pain
- •reporting, and/or confound evaluation of study endpoints, as determined by the
- •Investigator
- •7. Has mechanical spine instability as determined by the Investigator
- •8. Has undergone, within 30 days prior to enrollment, an interventional
- •procedure to treat back and/or leg pain, which is providing significant pain
- •9. Has unresolved major issues of secondary gain (e.g., social, financial,
- •legal), as determined by the investigator
- •10. Be involved in an injury claim under current litigation or has a pending or
- •has a pending or approved worker*s compensation claim
- •11. Be pregnant (determined by urine testing unless female subject is
- •surgically sterile or post-menopausal. If female, sexually active, and
- •childbearing age, subject must be willing to use a reliable form of birth
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