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临床试验/NCT03850743
NCT03850743
已完成
不适用

Biomarker Signatures of the Sleep-pain Enigma; a Collaborative Health Initiative Research Program (CHIRP) Funded Project

Defense and Veterans Center for Integrative Pain Management1 个研究点 分布在 1 个国家目标入组 111 人2019年2月2日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Post Surgical Pain and Sleep Impairment
发起方
Defense and Veterans Center for Integrative Pain Management
入组人数
111
试验地点
1
主要终点
Biomarker Expression
状态
已完成
最后更新
3个月前

概览

简要总结

This is an observational, prospective study that will leverage existing Standard of Care (SOC) patient reported outcomes (PRO) and Electronic Medical Record (EMR) data and collect additional Pain Rating Scale (PRS) data and blood samples from patients who consent to be in the study. Active duty service members and DEERS eligible patients who are injured and/or will undergo elective orthopaedic surgery are the target population.

详细描述

Sleep problems and pain, both acute and chronic, are common among military service members, reducing quality of life and military readiness. Evidence indicates sleep problems more strongly predict future acute and chronic pain than vice versa. This same pattern is also seen in the perioperative period, with sleep problems strongly predicting long-term post surgical pain. Though tightly linked, underlying biological mechanisms of the sleep-pain relationship in the perioperative period have yet to be identified, and treatment targets remain unknown. However, new technologies and methods in the areas of biomarker research (mRNA, microRNA, cytokine expression), as well as research describing psychosocial and clinical correlates, may help to identify patients most at-risk for long-term post-surgical sleep problems and pain, as well as identify new treatment targets.To address this research gap, the present observational study aims to collect four blood-samples from patients undergoing orthopedic surgeries at Walter Reed National Military Medical Center (WRNMMC) (N=240), both prior to and in the months following surgery, Additionally, patient reported outcomes, using the NIH's Patient Reported Outcome Measurement Information System (PROMIS), are collected as standard of care in the surgical clinics prior to surgery and for several years post-surgery. PROMIS scales cover a range of psychosocial (e.g., anxiety, depression, anger, social satisfaction, social isolation) and physical (e.g., fatigue, physical function) predictors. Through partnerships with the Defense and Veterans Center for Integrative Pain Management (USU), and WRNMMC Department of Orthopedic Surgery, the investigators will identify serum biomarkers (microRNA, cytokine expression) associated with pain and sleep-related outcomes prior to and in the months following surgery, as well as the role of psychosocial and clinical predictors, e.g. anxiety, depression, physical functioning, social functioning, opioid use) in outcomes. The long-term goal of this study are to understand risks for negative post-surgical outcomes, as well as help pave the way for future efforts to identify and test therapeutic interventions. Through this research, not only can the findings be used to improve surgical outcomes, but also increase quality of life among service members and force readiness.

注册库
clinicaltrials.gov
开始日期
2019年2月2日
结束日期
2024年3月20日
最后更新
3个月前
研究类型
Observational
性别
All

研究者

发起方
Defense and Veterans Center for Integrative Pain Management
责任方
Principal Investigator
主要研究者

Mary McDuffie

Research Nurse Manager

Defense and Veterans Center for Integrative Pain Management

入排标准

入选标准

  • Active duty military or DEERS eligible individuals
  • Between the ages of 18 and 60 years old
  • Able to understand written and spoken English
  • Eligible for healthcare within Military Health Systems
  • Having an orthopedic procedure at WRNMMC

排除标准

  • Bleeding Disorder
  • History of vasovagal response

结局指标

主要结局

Biomarker Expression

时间窗: Up to six months after surgery

To determine the biomarkers (microRNA, mRNA, proinflammatory cytokines) associated with the presence (risk-related) or absence (resilience related) of sleep dysregulation and pain prior to surgery. To determine the biomarkers associated with increases/maintenance (risk-related) and decreases (resilience-related) of sleep dysregulation and pain chronification after surgery. Protein Biomarker Analysis: The cytokine expression analysis will be done using the Human Inflammatory Cytokines Multi-Analyte ELISArray Kit. The cytokines and chemokines to be tested with this array include IL1α, IL1β, IL2, IL4, IL6, IL8, IL10, IL12, IL17A, IFNγ, TNFα, and GM-CSF (Qiagen Inc.). For this analysis, we will use 50ul of serum samples along with the 50ul of assay buffer which will be loaded in the ELISA strips.

研究点 (1)

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