PRECISION Pain Research Registry

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

Sponsors

Lead Sponsor: University of North Texas Health Science Center

Source University of North Texas Health Science Center
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.

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.

Overall Status Recruiting
Start Date 2016-04-01
Completion Date 2030-12-01
Primary Completion Date 2030-12-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Case-Control Status Upon registry enrollment
Enrollment 10000
Condition
Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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

Gender:

All

Minimum Age:

21 Years

Maximum Age:

79 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
John C Licciardone, DO, MS, MBA Principal Investigator University of North Texas Health Science Center
Overall Contact

Last Name: Cathleen Kearns, BA

Phone: 817-735-0515

Email: [email protected]

Location
Facility: Status: University of North Texas Health Science Center
Location Countries

United States

Verification Date

2021-04-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Chronic Low Back Pain Cases

Label: Chronic Pain-Free Controls

Acronym PRECISION
Patient Data Undecided
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

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 [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Research News