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PRECISION Pain Research Registry

Sponsor
University of North Texas Health Science Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04853732
Collaborator
(none)
10,000
Enrollment
1
Location
176
Anticipated Duration (Months)
56.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Case participants complete case report forms at quarterly encounters throughout an entire year, whereas control participants complete a case report form only at an initial encounter. Prior to 2021, case participants may have completed case report forms for a period of four years or longer.

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation
    Actual Study Start Date :
    Apr 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2030
    Anticipated Study Completion Date :
    Dec 1, 2030

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic Low Back Pain Cases
    Chronic Pain-Free Controls

    Outcome Measures

    Primary Outcome Measures

    1. Case-Control Status [Upon registry enrollment]

      Chronic Low Back Pain Case or Chronic Pain-Free Control

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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 forms independently or with assistance from registry staff

    • Must have a primary care physician or other physician who regularly provides health care

    • 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 healthy volunteers

    Exclusion Criteria:

    • Must not be pregnant

    • Must not reside in an institutional facility

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Texas Health Science Center Fort Worth Texas United States 76107

    Sponsors and Collaborators

    • University of North Texas Health Science Center

    Investigators

    • Principal Investigator: John C Licciardone, DO, MS, MBA, University of North Texas Health Science Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    University of North Texas Health Science Center
    ClinicalTrials.gov Identifier:
    NCT04853732
    Other Study ID Numbers:
    • #2015-169
    First Posted:
    Apr 21, 2021
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Low Back Pain

    Study Results

    No Results Posted as of Jun 1, 2022