Multi-center, Prospective, Randomized, Controlled, Clinical Trial for Idiopathic Hip Pain Using Peripheral Nerve Stimulation
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 主要终点
- Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
研究概览
简要总结
This is a prospective, randomized, multi-center study in which 300 evaluable subjects will be randomized 1:1 to receive Active or Delayed therapy with Moventis PNS. Subjects in the Delayed group will start with therapy at 3-month visit follow up.
详细描述
This is a prospective, randomized, controlled, multi-center study in which 300 evaluable subjects will receive Moventis PNS. Target subjects will have idiopathic hip pain.
Subjects will be randomized into either a delayed or immediate continuation group. Devices will be activated post-op in accordance to the randomization assignment. Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study. Implanted subjects will be educated on the use of the transmitter. Programming changes can be done as needed during this time period to maximize clinical response according to pre-programmed settings. Subjects randomized to the Delayed group will begin 2-hour stimulation/day at the 3-Month visit.
The primary endpoint is to demonstrate clinically significant improvements in the pain of patients in the active group compared to the subjects in the delayed group. The primary endpoint is defined as >50% pain relief at 3-months as measured by the Visual Analog Scale (VAS) without increase in baseline pain medications. Improvement will be assessed in relation to the clinical outcome measures of pain, with a target of >50% pain relief.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving informed consent;
- •Capable and willing to follow all study related procedures;
- •Women and men >18 years of age;
- •Diagnosis of hip pain;
- •Baseline VAS score of >5;
- •>50% temporary relief from temporary nerve diagnostic evaluation;
- •No evidence of anatomic abnormalities that could jeopardize device placement;
- •Able to operate programmer, recharger, study assessments and provide accurate responses;
- •Appropriate candidate for the implant procedure.
排除标准
- •An active implantable electronic device regardless of whether stimulation is ON or OFF;
- •Pregnant or plan to become pregnant during study;
- •Less than 1-year post-partum and/or are breast-feeding;
- •Symptoms existing for less than 6 months;
- •Multiple complaints that will not be amenable to study;
- •Current diagnosis of a Neurological disease;
- •Daily opioid usage exceeding CDC recommendations;
- •Dependency on utilizing wearable or transcutaneous monitoring device (hearing aids, continuous glucose monitors, etc.);
- •Conditions requiring recurring MRI evaluation or diathermy procedures;
- •Uncontrolled diabetes (HbA1C > 8.5);
- •Known or suspected substance abuse within the last 2-years;
- •Uncontrolled major depression or uncontrolled psychiatric disorders;
- •Worker's compensation claimants;
- •History of adverse reaction to local anesthetic drugs;
- •History of coagulopathy or bleeding disorder;
- •Anatomical restrictions such that device placement is not possible;
- •Chronic or acute conditions that could interfere with the interpretations of the outcome assessment for pain and bodily function;
- •Have a life expectancy of less than 1-year;
- •Neurogenic or vascular claudication;
- •Inability to achieve appropriate positioning and inability to understand informed consent and protocol;
- •Deemed unsuitable for enrollment by investigator based on history or physical examination.
研究组 & 干预措施
Active
Subjects randomized to the Active group, programming parameters will be set, and therapy will be delivered for a minimum of 2-hours per day for the duration of the study.
干预措施: Moventis PNS (Device)
Delayed
The delayed group will begin 2-hour stimulation/day at the 3-Month visit.
干预措施: Moventis PNS (Device)
结局指标
主要结局
Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale
时间窗: 3 Months
Improvement pain defined as a \>50% pain relief as measured by VAS without increase in baseline medications. To demonstrate clinically significant improvements in the pain of subjects in the active group compared to the subjects in the delayed group.
Adverse Events
时间窗: 3 Months
Device- and procedure-related Adverse Events (AE) rate at 3-months.
次要结局
- Change in Hip Pain: measured by Hip Pain Questionnaire(3, 6, 9, 12, 24, 36-months)
- Rate of Change in Pain Relief: >50% pain relief as measured by Visual Analog Scale(6, 9, 12, 24, 36-Months)