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

Pain Clinical Trial

— PRBiobank  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04004286
• Other study ID #: 900405
• Status: Recruiting
• Start date: February 1, 2019
• Est. completion date: February 2050

Study information

• Verified date: August 2023
• Source: Defense and Veterans Center for Integrative Pain Management
• Contact: Mary E McDuffie, RN,BSN
• Phone: 301/400/4242
• Email: mary.mcduffie.ctr[@]usuhs.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: February 2050
• Est. primary completion date: February 2050
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Eligibile for care within the Military Healthcare System

• Able and willing to provide written consent

Exclusion Criteria:

• Cannot understand English

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Defense and Veterans Center for Integrative Pain Management

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Pain Registry: Saliva	up to 10ml of saliva, collected in 2ml cryovials.	Up to 30 years