A European, Prospective, Multi-Center, Double-Blind, Randomized, Controlled, Clinical Trial Investigating the Effects of High Frequency Peripheral Nerve Stimulation (PNS) in the Treatment of Chronic Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Curonix LLC
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Responder rate
研究概览
简要总结
Prospective, double blinded, randomized, clinical study investigating the effects of high frequency PNS for the treatment of chronic back or back and leg pain.
详细描述
All subjects will have two permanent stimulators placed over the proximal peripheral nerves at T9 at the implant visit. The stimulators can easily be removed for non-responders. High frequency stimulation is typically programmed below sensory threshold. This type of stimulation lends itself to a placebo-controlled trial. For this study subjects will be randomized 1:1 at enrollment into a high frequency or sham group. Neither the subjects nor experimenters will be made aware of their randomization assignment for at least the first month of the trial. Subjects belonging to both groups will be unblinded to their assignment at the 1-month or a later visit (including unscheduled visit) if they have a VAS > 30 mms. Subjects belonging to the sham group will be reprogrammed with HF stimulation at this point. Subjects belonging to the HF stimulation group will keep stimulating with HF. Subjects reporting a VAS < 30 mms will continue to be blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Subjects and assessors randomized to HF blinded Subjects and assessors randomized to sham blinded
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 predominant, chronic, intractable back pain with a VAS > 50 mm (on a 100-mm scale);
- •Subjects have been diagnosed with predominant, chronic, intractable back pain for at least 6 months before study participation;
- •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;
- •Subject is willing to undergo surgical implant procedure, attend visits as scheduled, and comply with the study requirements;
- •Subject is willing and able to operate the patient programmer, recharging equipment and has the ability to undergo study assessments and provide accurate responses;
- •Based on the opinion of the implanter, subject is a good surgical candidate for the implant procedure;
- •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 and principal investigator, using face-to-face encounters and the psychological testing described in the measures;
- •Patient is capable of giving informed consent.
排除标准
- •Obvious mechanical instability related to pain (diagnosed by imaging taken within the past 6 months);
- •Unresolved malignancies in the 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 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 PNS experience for the treatment of back pain;
- •Conditions requiring Magnetic Resonance Imaging (MRI) evaluation or diathermy procedures.
研究组 & 干预措施
High Frequency
Subjects receiving high frequency pulse rate PNS treatment at T9 proximal peripheral nerves. Subjects and assessors blinded Randomization.
干预措施: PNS HF (Device)
Sham
Subjects receiving Sham (non-active) PNS treatment at T9 proximal peripheral nerves. Subjects and assessors blinded to randomization. Subjects and assessors to be unblinded if pain scores are 30 mms or higher with VAS after 1-month follow-up. Upon this moment subjects to receive active stimulation
干预措施: PNS Sham (Device)
结局指标
主要结局
Responder rate
时间窗: 1 month post-implant
a \> 50% reduction in back pain as measured by VAS with the Freedom PNS system in the HF (test) group as opposed to sham and conventional medical management
Responder rate
时间窗: 1 month post-implant
a \> 50% reduction in back pain as measured by VAS with the Freedom PNS system in the HF (test) group as opposed to sham and conventional medical management
次要结局
- VAS leg pain(1, 3, 6, 9, 12 and 36 months)
- VAS back pain(1, 3, 6, 9, 12 and 36 months)
- ODI(1, 3, 6, 9, 12 and 36 months)