Clinical trial NCT03850743: Biomarker Signatures of the Sleep-pain Enigma
Official title: Biomarker Signatures of the Sleep-pain Enigma; a Collaborative Health Initiative Research Program (CHIRP) Funded Project
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Surgical Pain and Sleep Impairment
Lead sponsor: Defense and Veterans Center for Integrative Pain Management
Sponsor class: OTHER
First posted: 2019-02-22
Enrollment: 111
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Active duty service members and DEERS eligible patients who are injured and/or will undergo elective orthopedic surgery. Up to 240 patients will be enrolled in this study at Walter Reed National Military Medical Center

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Bleeding Disorder
* History of vasovagal response

Primary outcomes:
measure: Biomarker Expression
timeFrame: Up to six months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Defense and Veterans Center for Integrative Pain Management
name: Chester C Buckenmaier, III, MD
role: PRINCIPAL_INVESTIGATOR
References: