Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Chronic Low Back Pain
Design
Observational Model: Case-ControlTime Perspective: Prospective

Participation Requirements

Age
Between 21 years and 79 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04853732
Collaborators
Not Provided
Investigators
Principal Investigator: John C Licciardone, DO, MS, MBA University of North Texas Health Science Center