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NCT Number: NCT04853732

PRECISION Pain Research Registry

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.

Recruiting

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Key information

Age range

21 year–79 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Case-Control Status

    Time frame: Upon registry enrollment

    Chronic Low Back Pain Case or Chronic Pain-Free Control

Study contacts

Contact information is provided by the study sponsor or research team.

Cathleen Kearns, BA

CONTACT

[email protected]

817-735-0515

Samantha Johnson, BS

CONTACT

[email protected]

817-735-5410

Sponsors and collaborators

Lead sponsor

University of North Texas Health Science Center

Other

Registry information

Official study title

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

Acronym: PRECISION

Important dates

Study start
2016
Primary completion
2030
Study completion
2030
First posted
Apr 21, 2021
Registry last updated
Jan 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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