PRECISION Pain Research Registry

Last updated: January 11, 2024
Sponsor: University of North Texas Health Science Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04853732
#2015-169
  • Ages 21-79
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The PRECISION Pain Research Registry enrolls participants with chronic low back pain (cases) and participants who are free of chronic pain (controls) to study the epidemiology and management of chronic pain. The vision of the registry is to conduct research to provide a future for all unbounded by pain.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must reside within the contiguous 48 United States or District of Columbia
  • Must provide a valid, government-issued identification with photo and birthdate
  • Must have Internet access or telephone service to communicate with registry staff
  • Must have sufficient English language proficiency to complete case report formsindependently or with assistance from registry staff
  • Must have a primary care physician or other physician who regularly provides healthcare
  • Must provide the name, dose, and frequency of use of all current medications
  • Case participants must have chronic low back pain
  • Control participants must be free of any chronic pain and may include healthyvolunteers

Exclusion

Exclusion Criteria:

  • Must not be pregnant
  • Must not reside in an institutional facility

Study Design

Total Participants: 10000
Study Start date:
April 01, 2016
Estimated Completion Date:
December 31, 2030

Study Description

Case participants complete case report forms at quarterly encounters, whereas control participants complete a case report form only at an initial encounter.

A series of validated or recommended research instruments are used or adapted by the registry for deployment in its case report forms. These may include some or all of the following at a given encounter:

  • National Institutes of Health Minimum Dataset for Research on Chronic Low Back Pain

  • Roland-Morris Disability Questionnaire

  • Patient-Reported Outcomes Measurement Information System (PROMIS-29)

  • History of Medical Conditions Inventory

  • Pain Sensitivity Questionnaire

  • Pain Catastrophizing Scale

  • Pain Self-Efficacy Questionnaire

  • Non-Pharmacological Treatments Inventory

  • Pharmacological Treatments Summary

  • Drug Adverse Events Index

  • Physician Profile

  • Physician Communication Behavior Questionnaire

  • Physician Consultation and Relational Empathy Measure

  • Patient Satisfaction Questionnaire (PSQ-18)

These instruments include measures that may serve as the independent or dependent variables in various substudies conducted by the registry over time, including observational studies (e.g., case-control studies, cohort studies) and randomized controlled trials.

The registry also maintains a biobank of biological specimens that have been collected from enrolled participants, including saliva and blood that may be used for DNA sequencing or biomarker analysis.

Connect with a study center

  • University of North Texas Health Science Center

    Fort Worth, Texas 76107
    United States

    Active - Recruiting

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