PRECISION Pain Research Registry

University of North Texas Health Science Center

Status: Enrolling

Conditions: Chronic Low Back Pain

Study type: Observational

Funder types: Other

Identifiers

NCT04853732

#2015-169

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10,000 estimated patients

Sex: All

Ages: 21 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

10,000 participants in 2 patient groups

Chronic Low Back Pain Cases

Chronic Pain-Free Controls