PRECISION Pain Research Registry

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Low Back Pain

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Low Back Pain Cases<br> | |
| Chronic Pain-Free Controls<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Case-Control Status | Chronic Low Back Pain Case or Chronic Pain-Free Control | Upon registry enrollment |