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Recruiting NCT04004286

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

Observational Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Pain. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Pain Registry: PASTOR survey [Time frame: Up to 30 years]
  • Pain Registry: Blood specimens [Time frame: Up to 30 years]
  • Pain Registry: Saliva [Time frame: Up to 30 years]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • Cannot understand English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Other

Study locations

United States · 2 centers
  • Naval Medical Center San Diego — San Diego
  • Walter Reed National Military Medical Center — Bethesda

Identifiers

NCT: NCT04004286 · 900405

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗