Clinical Trial Comparing Ultra-High Versus Traditional Pulse Widths Using the ALGOVITA® SCS System High Fidelity Stimulation in the Treatment of Persistent or Recurrent Back and/or Leg Pain Following Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Nuvectra
- 入组人数
- 20
- 试验地点
- 20
- 主要终点
- Effectiveness of targeted pain reduction compared to baseline in each treatment arm
研究概览
简要总结
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high pulse width or traditional pulse width for the treatment of persistent or recurrent back and/or leg pain following 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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Subjects who receive a permanent implant will be randomly assigned in a 1:1 ratio to one of the two sequences of treatment. Randomization schedules for each site will be prepared by the contract research organization (CRO) statistician and uploaded into a role-limited module of the study database. In order to avoid any potential bias, each site will designate an unblinded coordinator (UC). The UC, Nuvectra field personnel (FP) and the CRO will be unblinded to the treatment group. The participant and other site staff will be blinded to the treatment group.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with FBSS defined as persistent or recurrent back and/or leg pain despite one or more anatomically successful back surgeries for the same original pain.
- •Age 18-75 years old at consent.
- •Targeted pain intensity of ≥ 5 out of 10 on the Baseline visit NRS.
- •ODI score of 41-80 out of 100 at the Baseline visit.
- •Appropriate candidate for the surgical procedure and Algovita SCS therapy based on the clinical judgment of the investigator and the Algovita Instructions for Provider (IFP) in the Nuvectra product manuals.
- •On stable pain medications for at least 28 days prior to consent. Stable is defined as no new or discontinued pain medications and no changes to total daily dose of any pain medications.
- •Willing and capable of providing informed consent.
- •Willing and able of complying with the study-related requirements, procedures, and visits.
- •Speaks English as a primary language (as the Algovita patient manuals are only currently available in English).
- •Has adequate cognitive ability to use the subject devices (e.g., PPC, PoP), as determined by the investigator.
排除标准
- •Has a medical/psychological/psychiatric condition/disorder that could interfere with study procedures as determined by the investigator.
- •Has a coexisting pain condition that might confound pain ratings, as determined by the investigator.
- •Has a condition currently requiring or likely to require the use of MRI or diathermy.
- •Has an existing drug pump, SCS System, or other active implantable device.
- •Has any prior SCS experience.
- •Pregnant or planning to become (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years postmenopausal).
- •For subjects with diabetes, HbA1c ≥ 8.5% as measured at the Baseline visit (or within the 3 months prior to the Baseline visit).
- •Participating in another clinical trial that could affect the outcomes or requirements of this study as determined by the investigator.
- •Involved in an injury claim under current litigation or have a pending or approved workers compensation claim.
结局指标
主要结局
Effectiveness of targeted pain reduction compared to baseline in each treatment arm
时间窗: Week 25
The percentage of participants who experience at least a 50 percent reduction in targeted pain from baseline, as assessed by Numeric Rating Scale (NRS). The Numeric Rating Scale (NRS) will range from 0 to 10 with a higher score indicating a higher level of pain. Effectiveness will be compared both descriptively and statistically between the two randomized treatment groups using crossover analysis methods.
Rate of serious study-related adverse events (AEs) in each treatment arm
时间窗: From Permanent Implant through Week 25
The rate of serious study-related AEs. Study-related AEs are defined as any device, procedure and therapy/stimulation-related AEs.
次要结局
- Effectiveness of targeted pain reduction compared to baseline in each treatment arm(Week 12 and Months 12, 18 and 24)
- Effectiveness of back and/or leg pain reduction compared to baseline in each treatment arm(Weeks 12 and 25, and Months 12, 18 and 24)
- Effectiveness of targeted, back and/or leg pain reduction compared to baseline in each treatment arm(Weeks 12 and 25, and Months 12, 18 and 24)
- Clinician Global Impression of Change score in each treatment arm(Weeks 12 and 25, and Months 12, 18 and 24)
- Change in disability compared to baseline in each treatment arm(Weeks 12 and 25, and Months 12, 18 and 24)
- Change in quality of life compared to baseline in each treatment arm(Weeks 12 and 25, and Months 12, 18 and 24)
- Change in patient activity per the Pain Disability Index score in each treatment arm(Weeks 12 and 25, and Months 12, 18 and 24)
- Patient Global Impression of Change score in each treatment arm(Weeks 12 and 25, and Months 12, 18 and 24)
- Participant satisfaction per the subject satisfaction survey outcome in each treatment arm(Weeks 12 and 25, and Months 12, 18 and 24)
- Evaluation of trial success rates(From Trial Implant to End of Trail)
- Rate of surgical re-intervention of the SCS system(From Permanent Implant through Month 24)
- Change in targeted, back and/or leg pain compared to baseline in each treatment arm(Weeks 12 and 25, and Months 12, 18 and 24)