Defense and Veterans Center for Integrative Pain Management (DVCIPM) Pain Registry Biobank (PRBiobank)

Defense and Veterans Center for Integrative Pain Management (DVCIPM)Pain Registry Biobank

This Pain Registry Biobank is a prospective cohort design study whereby data (PASTOR survey, blood and saliva specimens, clinical data) is collected from participants in a longitudinal fashion with continual enrollment.

Study Overview

• Status: Recruiting
• Conditions: Pain

Detailed Description

The Defense and Veterans Center for Integrative Pain Management (DVCIPM) established a clinical data registry and tissue biobank (pain registry/biobank) for the advancement of pain-related research. This Pain Registry Biobank will address the complexity of pain by utilizing the Pain Assessment Screening Tool & Outcomes Registry (PASTOR), a thorough biopsychosocial assessment that extends beyond a single-item pain rating scale. PASTOR is an assessment battery that includes several Patient Reported Outcomes Measurement Information System (PROMIS) scales developed by the National Institutes of Health (NIH) and other important scales that span physical, psychological, social, and behavioral aspects of pain and pain-related treatments. As a uniform assessment system, PASTOR also mitigates a significant challenge in pain-related research, the lack of standardized, cross-study outcomes. Additionally, the richness of PASTOR data matched with biological samples allows future researchers to address significant research gaps and enhance health care for service members, veterans, and civilians.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Mary E McDuffie, RN,BSN; Phone Number: 301/400/4242; Email: mary.mcduffie.ctr@usuhs.edu

Study Locations

• United States
  • California
    • San Diego, California, United States, 92134
      • Recruiting
      • Naval Medical Center San Diego
      • Contact: Mary Jo Lindl, MS; Phone Number: 619-385-3569
      • Principal Investigator: Eugenio Lujan, MD
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Recruiting
      • Walter Reed National Military Medical Center
      • Contact: Mary E McDuffie, RN BSN; Phone Number: 301-400-4242; Email: mary.mcduffie.ctr@usuhs.edu
      • Principal Investigator: Harold J Gelfand, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Male and female military health care beneficiaries age 18 years and older presenting for an appointment care at WRNMMC

Description

Inclusion Criteria:

• Eligibile for care within the Military Healthcare System
• Able and willing to provide written consent

Exclusion Criteria:

• Cannot understand English

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Registry: PASTOR survey	a thorough biopsychosocial assessment computer adaptive screening tool that extends beyond a single-item pain rating scale. PASTOR is an assessment battery that includes several Patient Reported Outcomes Measurement Information System (PROMIS) scales developed by the National Institutes of Health (NIH) and other important scales that span physical, psychological, social, and behavioral aspects of pain and pain-related treatments.	Up to 30 years
Pain Registry: Blood specimens	43 ml of blood collected and processed for storage from EDTA, BDP 100, PAXgene RNA, and DNA blood collection tubes	Up to 30 years
Pain Registry: Saliva	up to 10ml of saliva, collected in 2ml cryovials.	Up to 30 years

Collaborators and Investigators

• Sponsor: Defense and Veterans Center for Integrative Pain Management
• Investigators: Principal Investigator: Harold J Gelfand, MD, Defense and Veterans Center for Integrative Pain Management

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Estimated): February 1, 2050
• Study Completion (Estimated): February 1, 2050

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): August 14, 2023
• Last Update Submitted That Met QC Criteria: August 10, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Pain PASTOR Biobank
• Other Study ID Numbers: 900405

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No