Post Surgical Pain and Sleep ImpairmentNCT03850743
Biomarker Signatures of the Sleep-pain Enigma
An observational study of Post Surgical Pain and Sleep Impairment, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Post Surgical Pain and Sleep Impairment
- How many people
- 111 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2019to 20 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
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
Who may be able to join
- 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
Who cannot join
- Bleeding Disorder
- History of vasovagal response
Trial locations and contacts
1 site in 1 country.
United States1 site
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
About this study
Official title: Biomarker Signatures of the Sleep-pain Enigma; a Collaborative Health Initiative Research Program (CHIRP) Funded Project
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.
Read the 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.
- Conditions
- Post Surgical Pain and Sleep Impairment
- Medical subject headings
- Pain, Postoperative
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start2 Feb 2019
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Surgical Pain and Sleep ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Defense and Veterans Center for Integrative Pain Management
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mary McDuffie, Defense and Veterans Center for Integrative Pain Management
- Investigators
- Chester C Buckenmaier, III, MD, Principal investigator, Defense and Veterans Center for Integrative Pain Management
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850743
- Sponsor's protocol ID
- 895846
- Status last verified
- May 2024
- First submitted
- 10 Dec 2018
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Signatures of the Sleep-pain Enigma; a Collaborative Health Initiative Research Program (CHIRP) Funded Project
- ClinicalTrials.gov ID
- NCT03850743
- Acronym / sponsor ID
- 895846
- Conditions
- Post Surgical Pain and Sleep Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Defense and Veterans Center for Integrative Pain ManagementUniversity, hospital or other
- Study start
- 2 Feb 2019 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 22 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Bleeding Disorder
- History of vasovagal response
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chester C Buckenmaier, III, MD principal investigator
Defense and Veterans Center for Integrative Pain Management
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Surgical Pain and Sleep Impairment, run by Defense and Veterans Center for Integrative Pain Management at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker Expression (time frame: Up to six months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.