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

Recruiting

• Conditions: Pain

• Registration Number: NCT04004286
• Lead Sponsor: Defense and Veterans Center for Integrative Pain Management

Brief Summary

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.

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 Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-10
• Last Update Posted: 2023-08-14
• Primary Completion: 2050-02
• Study Completion: 2050-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

Exclusion Criteria

• Cannot understand English

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Registry: PASTOR survey	Up to 30 years	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.
Pain Registry: Blood specimens	Up to 30 years	43 ml of blood collected and processed for storage from EDTA, BDP 100, PAXgene RNA, and DNA blood collection tubes
Pain Registry: Saliva	Up to 30 years	up to 10ml of saliva, collected in 2ml cryovials.

Trial Locations

Locations (2)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States