ISRCTN96424062已完成未知
Evaluation of the SenzaTM Spinal Cord Stimulation System for the treatment of chronic back pain in subjects without prior spinal surgery
evro Corp (USA)0 个研究点目标入组 21 人开始时间: 2012年10月26日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 21
研究概览
简要总结
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28025843 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29077889 (added 02/07/2019)
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. Age greater than 18 years, less than 65 years old
- •2. Low back pain for more than 6 months having failed conservative treatment (e.g., physical therapy, multiple facet joint injections)
- •3. Low back pain intensity =5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
- •4. Low back pain predominates over any radicular pain (VAS back pain 2 points or more greater than VAS leg pain)
- •5. Degenerative disc disease confirmed by imaging or internal disc disruption as confirmed by discography
- •6. On stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and not change medication dosage without consulting Investigator
- •7. Legally able to provide informed consent
- •8. Able to comply with study-related requirements, procedures and visits
排除标准
- •1. Had previous spinal fusion surgery
- •2. A current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, rapidly progressive diabetic peripheral neuropathy, brain or spinal cord tumor, or severe/critical central or foraminal spinal stenosis
- •3. Mechanical spine instability detected by a spinal surgeon (validation by flexion/extension films of lumbar spine within the past 6 months showing 4 mm or more translational movement or excessive angular movement manifested by >5 degrees segmental angular movement) e.g. any forms of spondylolisthesis
- •4. A medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
- •5. Diabetic who is poorly controlled through diet and/or medication (determined by the Investigator)
- •6. Bleeding diathesis such as coagulopathy or thrombocytopenia
- •7. Immunocompromised and at an increased risk for infection
- •8. Systemic infection or local infection that would contraindicate SCS placement
- •9. Metastatic malignant disease or active local malignant disease
- •10. Pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
- •11. Active alcohol, marijuana, recreational or prescription drug abuse or dependence or unwilling to stop/reduce excessive inappropriate medication.
- •12. Evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome as determined by the Investigator
- •13. Life expectancy of less than 1 year
- •14. Concomitant participation in clinical trial (device or drug)
- •15. An existing drug pump, SCS system, and/or another active implantable device
- •16. An interventional procedure and/or surgery within the past 30 days for treatment of pain condition
- •17. Inability to manage the technical demands of the SCS equipment
研究者
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