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临床试验/NCT04960592
NCT04960592已完成不适用

Epigenetic Mechanisms and Symptom Clusters Associated With the Resolution of Persistent Pain Following Spinal Cord Stimulation

University of Arkansas0 个研究点目标入组 61 人开始时间: 2021年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
61
主要终点
Genes and regulatory regions associated with the resolution of chronic pain

研究概览

简要总结

Spinal cord stimulation (SCS) is indicated for selected patients with chronic pain who have not responded to conventional medical management.

Forty (40) patients indicated for SCS placement and presenting to the University of Arkansas for Medical Sciences (UAMS) Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Prior to temporary stimulator placement, patients will complete symptom-related questionnaires and provide a blood sample. Demographic and clinical characteristics will be obtained through medical record review. Patients will complete the same questionnaires and provide a blood sample at each of the routine clinical care follow-up visits.

详细描述

Neuromodulation has emerged as a minimally invasive therapy effective for the treatment of refractory neuropathic pain conditions. Epidural placement of electrodes provides long term analgesia through electrical stimulation of the spinal cord which alters expression of genes involved in synaptic signaling in the dorsal horn. Patients who receive SCS represent a unique opportunity to study the physiological mechanisms associated with the resolution of chronic pain.

This is a descriptive, prospective, longitudinal study that will consist of individuals with persistent pain and meet criteria for implantation of a neurostimulation device. One hundred patients indicated for neurostimulation device placement and presenting to the University of Arkansas for Medical Sciences Interventional Pain Management Clinic in Little Rock, Arkansas will be recruited for this study. Patients who meet study inclusion criteria will be recruited to participate prior to stimulator placement procedure. Following an initial consultation and exam by a physician, patients will have necessary imaging and neuropsychological evaluation. Prior to SCS placement procedure, the patient will complete preoperative labs.

At baseline, patients will be asked to complete the demographic questionnaire, and physical functioning questionnaires, and provide a blood sample. Blood samples will be drawn and stored until sample processing is completed. Medical records will be reviewed and abstracted for research-related data elements from electronic medical records. Questionnaire and form responses are collected and recorded for study use.

Study time points for data collection and sample collection are Baseline (Pre-treatment), routine follow-up visit < 60 days after baseline, 3 months, and 1-year post-implant procedure.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults (age greater than or equal to18 years) who meet clinical criteria for implantation of a neuromodulation device
  • Able to speak, write, and understand English

排除标准

  • Evidence of monetary gain related to the outcome of the procedure (example worker's compensation, ongoing litigation, pending disability claim)
  • Pain greater than 4/10 on pain scale at a bodily site not being treated by the neuromodulation procedure

结局指标

主要结局

Genes and regulatory regions associated with the resolution of chronic pain

时间窗: 24 months

Identification of genes that are associated with the resolution of pain

Changes in the day to day functioning

时间窗: 24 months

Identification of psychosocial measures (i.e., patient reported outcome measures; pain catastrophizing) and patient reported functioning associated with the resolution of pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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