ISRCTN87648175招募中不适用
A multi-center, prospective, pragmatic, randomized, controlled clinical trial to compare HF10 therapy to Conventional Medical Management in the treatment of Non-Surgical Refractory Back Pain
evro Corp0 个研究点目标入组 300 人开始时间: 2017年11月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
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
- 性别
- All
入选标准
- •1. Have been diagnosed with chronic, refractory axial low back pain with a neuropathic component
- •2. Have failed conventional medical treatments
- •3. Have not had any surgery for back or leg pain, or any surgery resulting in back or leg pain
- •4. Demonstrating multi-level Degenerative Disc Disease and no current indication for referral for back surgery
- •5. Considering daily activity and rest, have average back pain intensity of = 5 out of 10 cm on the Visual Analog Scale (VAS) at enrollment
- •6. Average back pain intensity greater than average leg pain intensity on the Visual Analog Scale (VAS) at enrollment
- •7. Be on stable pain medications, as determined by the Investigator
- •8. Be 18 years of age or older at the time of enrollment
- •9. Be willing and capable of giving informed consent
- •10. Be willing and able to comply with study-related requirements, procedures, and visits
- •11. Be capable of subjective evaluation, able to read and understand written questionnaires in the local language and are able to read, understand and sign the written inform consent
排除标准
- •1. Have a diagnosed back condition with inflammatory causes of back pain, serious spinal pathology and/or neurological disorders
- •2. Have a medical condition or pain in other area(s), not intended to be treated in this study
- •3. Any diagnosis or known condition that can impact reporting of study outcomes as determined by the Investigator
- •4. Have significant clinically mechanical spine instability
- •5. Be benefitting within 30 days prior to enrollment from an interventional procedure to treat back and/or leg pain
- •6. Have an opioid addiction or drug seeking behavior as determined by the Investigator
- •7. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker
- •8. Have prior experience with neuromodulation devices
- •9. Have a condition currently requiring or likely to require the use of diathermy or MRI that is inconsistent with Senza system guideline in the Physician’s Manual
- •10. Have metastatic malignant disease or active local malignant disease
- •11. Have a life expectancy of less than 2 years
- •12. Have an active systemic or local infection
- •13. Be pregnant (participants of child-bearing potential that are sexually active must use a reliable form of birth control)
- •14. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
- •15. Be concomitantly participating in another clinical study
- •16. Be involved in an injury claim under current litigation
- •17. Have a pending or approved worker’s compensation claim
研究者
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