NCT06152029终止不适用
Efficacy of a Temporary Peripheral Nerve Stimulation System in Patients With Osteoarthritis of the Knee
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.
研究概览
简要总结
The purpose of this study is to demonstrate the treatment outcomes of patients with chronic knee pain secondary to osteoarthritis that have received a temporary peripheral nerve stimulation system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of 21 and older
- •Will receive a temporary PNS system for the management of chronic knee pain secondary to osteoarthritis
- •Be capable of subjective evaluation, able to read and understand English-written questionnaires, and able to read, understand and sign the written informed consent in English
- •Be willing and capable of giving informed consent
- •Be willing and able to comply with study-related requirements, procedures, and scheduled visits
排除标准
- •No knee pain at rest
- •Same nerve targeted for both Radiofrequency Ablation (RFA) and Peripheral Nerve Stimulation (PNS) in less than 6 months post RFA, if applicable
- •Pregnancy
- •History of repetitive skin infections
- •Vulnerable populations (e.g., prisoners, minors, students, employees)
- •Any other condition that may interfere with the ability to participate in a clinical trial (e.g., anatomy that may interfere with lead placement, nerve damage, compromised immune system, uncontrolled diabetes)
- •Confounding conditions such as lumbar radiculopathy
- •Deep brain stimulation system, implanted active cardiac implant (e.g. pacemaker of defibrillator), or any other implantable neuro-stimulator whose stimulus current pathway may overlap the SPRINT system.
- •Be involved in an injury claim under current litigation
- •Be a recipient of temporary Social Security Disability Insurance (SSDI) benefits due to chronic pain
- •Have a pending or approved worker's compensation claim
结局指标
主要结局
Average change from baseline to end of treatment in average pain intensity measured through BPI-SF item 5.
时间窗: up to 60 days post lead placement
次要结局
- Overall patient global impression of change (PGIC) at end of treatment.(up to 60 days post lead placement)
- Overall incidence of lead migration/fracture during the study.(12 months)
- Average change from baseline to 6- and 12-months post-explant in pain interference measured through BPI-SF.(7 and 30 days post lead placement; and 6 and 12 month post lead pull)
- Average change from baseline to end of treatment in health-related quality of life measured through PROMIS-29.(up to 60 days post lead placement)
- Average change from baseline to end of treatment in pain interference measured through BPI-SF.(up to 60 days post lead placement)
- Average change in chronic pain related medication intake at end of treatment compared to baseline in Morphine Miligram Equivalents (MME)(up to 60 days post lead placement)
- Overall incidence of lead migration/fracture at the end of treatment.(up to 60 days post lead placement)
- Average change from baseline to 7- and 30-days post-implant; and 6- and 12-months post-explant in average pain intensity measured through BPI-SF item 5.(7 and 30 days post lead placement; and 6 and 12 month post lead pull)
- Average change from baseline to 6- and 12-months post-explant in health-related quality of life measured through PROMIS-29.(7 and 30 days post lead placement; and 6 and 12 month post lead pull)
- Overall patient global impression of change (PGIC) at 6 months and end of study.(6 and 12 months post lead pull)
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
2 期
Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer SurgeryRectal CancerLow Anterior Resection SyndromeNCT02177084IRCCS Azienda Ospedaliero-Universitaria di Bologna12
招募中
不适用
Peripheral Nerve Stimulation for Treatment of Sacroiliac Joint PainSacroiliac Joint PainNCT05357300PD Dr. med. Simon Bayerl90
已完成
不适用
The Effect of Transcutaneous Posterior Tibial Nerve Stimulation in Patients With FibromyalgiaFibromyalgiaNCT05937711Ilker Fatih Sari64
已完成
不适用
Long-term Efficacy of Percutaneous Tibial Nerve Stimulation Applied to Patients With Faecal Incontinence.Faecal IncontinenceNCT05016453Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana139
终止
1 期
Prospective, Multicenter Trial to Investigate the Safety and Efficacy of Percutaneous Tibial Nerve Stimulation for the Treatment of Fecal IncontinenceFecal IncontinenceNCT01666405Uroplasty, Inc30