Comparison of Differential Target Multiplexed Spinal Cord Stimulation (DTM™ SCS) Therapy Combined With CMM to CMM Alone in the Treatment of Intractable Back Pain Subjects Without Previous History of Lumbar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 12
- 主要终点
- Percentage of Individual Responders
研究概览
简要总结
The purpose of this investigational study is to document the safety, clinical effectiveness and health economic analytics of DTM™ SCS programming delivered through the Intellis™ neurostimulator in subjects with chronic, intractable pain of the trunk with or without lower limb pain, including unilateral or bilateral pain without prior history of spine surgery and refractory to conservative treatment and are not candidates for lumbar spinal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be a candidate for SCS system (trial and implant)
- •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
- •Has an average back pain intensity ≥ 6.0 cm on the 10.0 cm Visual Analog Scale (VAS) at the time of enrollment
- •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.
- •Be willing and capable of subjective evaluation, read and understand written questionnaires, and read, understand and sign the written inform consent
- •Be 18 years of age or older at the time of enrollment
- •Be on a stable pain medication regime, as determined by the study investigator, for at least 30 days prior to enrolling in this study
- •Be willing and able to comply with study-related requirements, procedures, and visits
排除标准
- •Had a previous spinal surgery (e.g., lumbar fusion, discectomy, laminectomy, laminotomy)
- •Has a medical, anatomical, and/or psychosocial condition that is contraindicated for commercially available Intellis™ SCS systems as determined by the Investigator
- •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
- •Be concurrently participating in another clinical study
- •Has an existing active implanted device such as a pacemaker, another SCS unit, peripheral nerve stimulator, and/or drug delivery pump, etc.
- •Has pain in other area(s) and/or medical condition requiring the regular use of significant pain medications that could interfere with accurate pain reporting, study procedures, and/or confound evaluation of study endpoints, as determined by the Investigator
- •Has mechanical spine instability as determined by the Investigator
- •Has undergone, within 30 days prior to enrollment, an interventional procedure and/or surgery to treat back and/or leg pain, which is providing significant pain relief
- •Has unresolved major issues of secondary gain (e.g., social, financial, legal), as determined by the investigator
- •Be involved in an injury claim under current litigation or has a pending or approved worker's compensation claim
- •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 control.)
研究组 & 干预措施
Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM)
Subjects will undergo a Trial Phase with DTM™ SCS programming. Stimulation will be delivered from an external neurostimulator. Those who have a "successful Trial Phase" will proceed to permanent implantation of the Intellis™ SCS system to evaluate DTM™ SCS therapy and will undergo up to 24 months of stimulation delivery.
Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the DTM™ SCS + CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the CMM group. If all SCS programming attempts fail, then DTM™ SCS therapy will be switched off and the subject will continue with their CMM treatment and will visit the clinic approximately a total of 18 months follow-up in the study (i.e. 6 months DTM™ SCS and 12 months CMM).
干预措施: DTM™ spinal cord stimulation therapy delivered via Intellis™ neurostimulator system (Device)
Test Group - DTM™ SCS programming approach with Conventional Medical Management (CMM)
Subjects will undergo a Trial Phase with DTM™ SCS programming. Stimulation will be delivered from an external neurostimulator. Those who have a "successful Trial Phase" will proceed to permanent implantation of the Intellis™ SCS system to evaluate DTM™ SCS therapy and will undergo up to 24 months of stimulation delivery.
Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the DTM™ SCS + CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the CMM group. If all SCS programming attempts fail, then DTM™ SCS therapy will be switched off and the subject will continue with their CMM treatment and will visit the clinic approximately a total of 18 months follow-up in the study (i.e. 6 months DTM™ SCS and 12 months CMM).
干预措施: Conventional Medical Management (CMM) (Other)
Control Group - Conventional Medical Management (CMM) alone
The choice of appropriate CMM will be made by the Investigator as determined to be the best standard of care for each individual subject i.e. optimized individual conventional therapy. These treatments would be generally consistent with the American College of Physicians and the American Pain Society Guidelines as published in the Annals of Internal Medicine and European/UK guidelines. Subjects in this group will also undergo up to 24 months of CMM.
Subjects randomized to either treatment group will have the optional possibility to crossover to the alternative treatment arm after the 6-month visit. If the subject and investigator believe that the CMM treatment has not generated sufficient pain relief to warrant continued treatment, then the subject will be provided with the option to crossover to the DTM™ SCS therapy group. Following their device activation, they will attend visits approximately a total of 18 months follow-up in the study (i.e. 6 months CMM and 12 months DTM™ SCS).
干预措施: Conventional Medical Management (CMM) (Other)
结局指标
主要结局
Percentage of Individual Responders
时间窗: 6 months
Individual Responders defined as decrease in back pain rating on 10 cm Visual Analog Scale (VAS) by at least 50%. Visual Analog Scale is a scaled psychometric instrument to report pain severity on a 10 cm line, with 0 indicating no pain and 10 indicating the worst pain imaginable.
次要结局
- Percentage of Individual Responders(24 months)
- Change From Baseline in Visual Analog Scale (VAS) Back Pain Score(24 months)
- Percentage of Individual Responders(1 month)
- Percentage of Individual Responders(3 months)
- Percentage of Individual Responders(9 months)
- Percentage of Individual Responders(12 months)
- Percentage of Individual Responders(18 months)
- Change From Baseline in Visual Analog Scale (VAS) Back Pain Score(1 month)
- Change From Baseline in Visual Analog Scale (VAS) Back Pain Score(3 months)
- Change From Baseline in Visual Analog Scale (VAS) Back Pain Score(6 months)
- Change From Baseline in Visual Analog Scale (VAS) Back Pain Score(9 months)
- Change From Baseline in Visual Analog Scale (VAS) Back Pain Score(12 months)
- Change From Baseline in Visual Analog Scale (VAS) Back Pain Score(18 months)