Embrace TDD: Prospective, Multi-Center, Post Market Study to Evaluate Intrathecal (IT) Morphine as an Alternative to Systemic Opioids for the Treatment of Chronic, Intractable, Non-Malignant Primary Back Pain With or Without Leg Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 93
- 试验地点
- 16
- 主要终点
- Number of Participants With Clinical Success at the 6-Month Visit
研究概览
简要总结
This is a prospective, multi-center, post market study to evaluate Intrathecal (IT) preservative-free morphine sulfate (PFMS) using the SynchroMed™ II infusion system as an alternative to systemic opioids for the treatment of chronic, intractable, non-malignant primary back pain with or without leg pain.
详细描述
Subjects will be assessed for pain control and opioid-related side effects following a route of delivery change from systemic opioids to IT morphine therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Willing and able to provide a signed and dated (Medtronic and Institutional Review Board (IRB) approved) Informed Consent Form (ICF) and Health Insurance Portability and Accountability Act (HIPAA) Authorization Form prior to any study procedures being performed
- •A candidate per labeling for the Intrathecal Drug Delivery System (IDDS)
- •A diagnosis of chronic, intractable, non-malignant primary back pain with or without leg pain, treatable with the IDDS
- •Current daily systemic opioid dose of >0 and ≤ 120 Morphine Milligram Equivalents (MME)
- •A Visual Analogue Scale (VAS) of ≥50 mm for pain intensity at the Baseline Visit and/or a Numerical Opioid Side Effect (NOSE) Assessment Tool ≥40 for intolerable side effects at the Baseline Visit
- •Psychological evaluation or investigator assessment of patient psychological suitability for study participation
- •Has an MRI or CT prior to enrollment verifying patent spinal canal and no clinical change in status since last imaging
- •At least 18 years old at time of enrollment
- •Willing and able to attend visits and comply with the study protocol
- •Male or non-pregnant, non-lactating female. Females must be post-menopausal or surgically sterile; or be utilizing a medically acceptable form of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, or condom with spermicide) for the duration of the study
排除标准
- •Previously trialed or implanted with an IDDS
- •Concomitant stimulation device implanted for the treatment of pain
- •Any ongoing health condition that would be expected to interfere with pain and/or quality of life ratings (i.e. active malignancy, other painful conditions not treatable with IT therapy, etc.)
- •Psychological or other health conditions, financial and/or legal concerns that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's discretion
- •Substance Use Disorder (SUD) within the last 2 years or current Medication Assisted Treatment (MAT) for substance use disorder
- •Currently using cannabinoids or illicit drugs
- •History of allergy or significant adverse reaction to morphine per investigator discretion
- •Currently participating or plans to participate in another investigational study unless written approval is provided by Medtronic Study Team
研究组 & 干预措施
Intrathecal Therapy
Enrolled subjects who successfully wean from all systemic opioids and have a successful intrathecal trial, proceed to the intervention phase. This includes implantation with a SynchroMed™ II infusion system in the intrathecal space for targeted drug delivery of preservative-free morphine sulfate (PFMS).
干预措施: Medtronic SynchroMed™ II infusion system (Device)
Intrathecal Therapy
Enrolled subjects who successfully wean from all systemic opioids and have a successful intrathecal trial, proceed to the intervention phase. This includes implantation with a SynchroMed™ II infusion system in the intrathecal space for targeted drug delivery of preservative-free morphine sulfate (PFMS).
干预措施: Preservative-free morphine sulfate (PFMS) (Drug)
结局指标
主要结局
Number of Participants With Clinical Success at the 6-Month Visit
时间窗: Baseline to 6-Month Visit
To characterize the number of subjects with Clinical Success at the 6-Month Visit. Clinical Success is defined as any of the following: 1) Reduced opioid-related side effects (at least a 20% reduction) with equal pain (less than 20% increase or decrease) 2) Reduced pain (at least a 20% reduction) with equal opioid-related side effects (less than 20% increase or decrease) 3) Reduced pain and reduced opioid-related side effects (at least a 20% reduction in both). The number of subjects with Clinical Success at the 6-Month Visit is presented.
次要结局
- Visual Analog Scale (VAS) Pain Intensity at the 6-Month Visit(Baseline to 6-Month Visit)
- Numerical Opioid Side Effect (NOSE) Assessment Tool(Baseline to 6-Month Visit)
- Number of Participants With Systemic Opioid Elimination Through the 6-Month Visit(Baseline to 6-Month Visit)