CRCNS: Model-based Characterization of Spinal Cord Stimulation for Pain

University of Michigan1 个研究点分布在 1 个国家目标入组 34 人开始时间: 2021年9月11日最近更新: 2026年3月27日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Michigan
入组人数: 34
试验地点: 1
主要终点: Spinal Cord Stimulation (SCS)-Induced Changes in Temporal Summation (TS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. This type of treatment is referred to as neurostimulation. A common form of neurostimulation therapy is spinal cord stimulation (SCS). In this study, how SCS affects pain processing and relieves pain will be studied. Multiple forms of SCS will be examined in chronic pain patients who are receiving SCS from their own doctors as part of their standard of care. During the study, participants will be asked to complete a variety of evaluations at certain time points.

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: Double (Participant, Outcomes Assessor)

盲法说明

There will be two research teams. One team will be unblinded (e.g., clinical care provider/company representative, study coordinator) and will perform stimulator programming/adjustment, and the other team will be blinded (e.g., research personnel) and will perform clinical testing and collect study outcome measures.

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

•Chronic intractable pain of the trunk and/or limbs
•Undergoing SCS as part of standard clinical care for chronic pain management
•Candidates will have been implanted with a commercial SCS device
•Candidates who are 18 years or older and can speak, read, and understand English
•Able to understand study procedures and to comply with them for the entire length of the study
•Must be willing to participate in COVID-19 symptom screening and answer questions about COVID-19 diagnosis 1-3 days before a scheduled visit
•Must be willing to wear a face-covering during all study visits

排除标准

•Subjects who are pregnant or nursing
•Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail
•Subjects who are unable or unwilling to cooperate with clinical testing
•Subjects having any impairment, activity or situation that in the judgment of study personnel would prevent satisfactory completion of the study protocol
•Inability or unwillingness of individual or legal guardian/representative to give written informed consent
•Subjects who currently have or tested positive in the last 14 days for COVID-19, or are symptomatic for COVID-19

研究组 & 干预措施

Burst / kHz / Sham / Tonic

Experimental

Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.