Biomarker Signatures of the Sleep-pain Enigma

NCT03850743 | Completed

• 1 other identifier: 895846
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Surgical Pain and Sleep Impairment

Outcome Measures

Primary Outcomes (1)

• Biomarker Expression

  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.

  Up to six months after surgery

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Bleeding Disorder
• History of vasovagal response

Sponsors & Collaborators

• Defense and Veterans Center for Integrative Pain Management: lead

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Chester C Buckenmaier, III, MD

  Defense and Veterans Center for Integrative Pain Management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Nurse Manager

Study Record Dates

• First Submitted: December 10, 2018
• First Posted: February 22, 2019
• Study Start: February 2, 2019
• Primary Completion: March 20, 2024
• Study Completion: March 20, 2024
• Last Updated: January 28, 2026

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)