Multi-center, Prospective, Clinical Trial of Wireless Spinal Cord Stimulation in the Treatment of Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Curonix LLC
- 入组人数
- 49
- 试验地点
- 14
- 主要终点
- Pain Score
研究概览
简要总结
The purpose of this study is to assess the effectiveness of the Stimwave Spinal Cord Stimulator (SCS) System for treatment of chronic pain
详细描述
This is a multi-center, prospective study in which subjects will receive a Freedom SCS System and to receive stimulation at a frequency between 5 Hz to 1500 Hz . Enrollment will continue until 49 subjects have been implanted.
Subjects will have chronic back or back and leg pain refractory to standard medical treatment associated with Failed Back Surgery Syndrome (FBSS). Subjects will be followed for a 6-month period after a maximum one-month trial period. At the end of 6 months follow-up, all subjects will assess the outcomes of their appointed therapy and continue with long-term use of the system.
Stimulators will be placed at the following sites to target the painful area:
• Epidural Space midline covering vertebrae levels T8 through T11 (one stimulator placed at the top of T8 and the second stimulator placed at the middle of T9). Paresthesia mapping will be utilised to determine the optimal location for stimulation of the painful area.
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
- •Subject is ≥ 18 years of age at time of informed consent;
- •Subjects have been diagnosed with chronic back or back and leg pain with an average VAS > 5 (on a 10 scale) over the course of the last month for back pain based on baseline pain diary;
- •Subject diagnosis with chronic back or back and leg pain associated with FBSS refractory to conventional medical management for at least 12 months prior to enrollment;
- •Based on the medical opinion of the Principal Investigator, subject has a stable pain medication regiment;
- •Based on the medical opinion of the Principal Investigator, there is no evidence of anatomic abnormalities that could jeopardize the placement of the device or pose a hazard to the subject;
- •Based on the opinion of the Principal Investigator, subject is willing and able to operate the patient programmer, recharging equipment, diary and has the ability to undergo study assessments and provide accurate responses;
- •Based on the opinion of the implanter, subject is a good surgical subject for the implant procedure;
- •Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
- •Subject is male or non-pregnant female;
- •Subject is deemed to be neuro-psycho-socially appropriate for implantation therapies based of the assessment of a Clinical Psychologist, using face-to-face encounters and the psychological testing described in the measures;
- •Subject is capable of giving informed consent;
- •Subject lives within reasonable distance from the study site (circumference of 50 miles).
排除标准
- •Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
- •Unresolved Malignancies in last six months;
- •Subject has post-herpetic neuralgia (shingles);
- •Subject has an active systemic infection or is immune-compromised;
- •Based on the medical opinion of the Principal Investigator, Psychologist and/or Psychiatrist, the subject has other psychological conditions (e.g., psychosis, suicidal ideation, borderline personality disorder, somatization, narcissism), other health conditions (e.g., substance abuse, another chronic condition requiring the regular use of opioid medication), or other legal concerns that would preclude his/her enrollment in the study or potentially confound the results of the study;
- •Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study while participating in this study;
- •Insulin-dependent diabetic who is not controlled through diet and/or medication (determined by the physician) or non-insulin dependent diabetic who is not well controlled through diet and/or medication;
- •Bleeding complications or coagulopathy issues;
- •Pregnant/lactating or not using adequate birth control;
- •A life expectancy of less than one year;
- •Any active implanted device whether turned off or on;
- •A previous SCS experience;
- •Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.
结局指标
主要结局
Pain Score
时间窗: 6 Months
A 50% reduction in VAS scores when compared to baseline.
次要结局
- Oswestry Disability Index (ODI) Score(6 Months)
- Sleep Quality(6 Months)
- Procedure time(7 Days post implant)
- Patient Satisfaction(6 Months)
- Disability Score(6 Months)
- Opioid Reduction(6 Months)
- Adverse Events(6 Months)
- Percentage change in VAS Back from baseline(6 Months)
- Percentage change in VAS Leg from baseline(6 Months)