Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-27 @ 3:18 AM
Study NCT ID:
NCT04853732
Status:
RECRUITING
Last Update Posted:
2024-01-16
First Post:
2021-04-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRECISION Pain Research Registry
Sponsor:
University of North Texas Health Science Center
Organization:
Study Overview
Official Title:
Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRECISION
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, 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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: