Biomarker Signatures of the Sleep-pain Enigma

• ClinicalTrials.gov Identifier: NCT03850743
• Recruitment Status: Active, not recruiting
• First Posted: February 22, 2019
• Last Update Posted: August 23, 2021
• Sponsor: Defense and Veterans Center for Integrative Pain Management
• Information provided by (Responsible Party): Mary McDuffie, Defense and Veterans Center for Integrative Pain Management

Study Description

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.

Condition or disease
Post Surgical Pain and Sleep Impairment

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 111 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Biomarker Signatures of the Sleep-pain Enigma; a Collaborative Health Initiative Research Program (CHIRP) Funded Project
• Actual Study Start Date: February 2, 2019
• Estimated Primary Completion Date: June 2022
• Estimated Study Completion Date: June 2022

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

1. Biomarker Expression [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• 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

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

Contacts and Locations

Locations

United States, Maryland

Walter Reed National Military Medical Center

Bethesda, Maryland, United States, 20889

Sponsors and Collaborators

Defense and Veterans Center for Integrative Pain Management

Investigators

• Principal Investigator: Chester C Buckenmaier, III, MD; Defense and Veterans Center for Integrative Pain Management

  Study Documents (Full-Text)

Documents provided by Mary McDuffie, Defense and Veterans Center for Integrative Pain Management:

Informed Consent Form  [PDF] July 12, 2019

More Information

• Responsible Party: Mary McDuffie, Research Nurse Manager, Defense and Veterans Center for Integrative Pain Management
• ClinicalTrials.gov Identifier: NCT03850743
• Other Study ID Numbers: 895846
• First Posted: February 22, 2019
• Last Update Posted: August 23, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations