Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03850743 |
| Other study ID # |
895846 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 2, 2019 |
| Est. completion date |
March 20, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Defense and Veterans Center for Integrative Pain Management |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
