PRECISION Pain Research Registry (PRECISION)

January 11, 2024 updated by: University of North Texas Health Science Center

Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Fort Worth, Texas, United States, 76107
        • Recruiting
        • University of North Texas Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will be selected from patients seeking ongoing health care from a physician within the contiguous 48 United States or District of Columbia.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Chronic Low Back Pain Cases
Chronic Pain-Free Controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Case-Control Status
Time Frame: Upon registry enrollment
Chronic Low Back Pain Case or Chronic Pain-Free Control
Upon registry enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Texas Health Science Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #2015-169

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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