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Clinical Trials/NCT04004286
NCT04004286
Recruiting
Not Applicable

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

Defense and Veterans Center for Integrative Pain Management2 sites in 1 country300 target enrollmentFebruary 1, 2019
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Defense and Veterans Center for Integrative Pain Management
Enrollment
300
Locations
2
Primary Endpoint
Pain Registry: PASTOR survey
Status
Recruiting
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2019
End Date
February 1, 2050
Last Updated
3 months ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Defense and Veterans Center for Integrative Pain Management
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Cannot understand English

Outcomes

Primary Outcomes

Pain Registry: PASTOR survey

Time Frame: 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

Time Frame: 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

Time Frame: Up to 30 years

up to 10ml of saliva, collected in 2ml cryovials.

Study Sites (2)

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