PRECISION Pain Research Registry

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Case-Control Status [Срок оценки: Upon registry enrollment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Must not be pregnant
• Must not reside in an institutional facility

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• University of North Texas Health Science Center — Fort Worth

Публикации

• Licciardone JC, Gatchel RJ, Aryal S. Effects of Opioids and Nonsteroidal Anti-Inflammatory Drugs on Chronic Low Back Pain and Related Measures: Results from the PRECISION Pain Research Registry. Tex Med. 2018 Oct 1;114(10):e1. PMID 30281768
• Licciardone JC, Schmitt ME, Aryal S. Empathy in Medicine Osteopathic and Allopathic Physician Interpersonal Manner, Empathy, and Communication Style and Clinical Status of Their Patients: A Pain Registry-Based Study. J Am Osteopath Assoc. 2019 Aug 1;119(8):499-510. doi: 10.7556/jaoa.2019.092. PMID 31305871
• Licciardone JC, Gatchel RJ. Osteopathic Medical Care With and Without Osteopathic Manipulative Treatment in Patients With Chronic Low Back Pain: A Pain Registry-Based Study. J Am Osteopath Assoc. 2020 Feb 1;120(2):64-73. doi: 10.7556/jaoa.2020.016. PMID 31985765
• Licciardone JC. Assessment of Longitudinal Clinical Outcome Measures for Chronic Low Back Pain over 12 Months. J Gen Intern Med. 2020 Dec;35(12):3733-3735. doi: 10.1007/s11606-020-05723-3. Epub 2020 Feb 19. No abstract available. PMID 32076968
• Licciardone JC, Pandya V. Use of Complementary Health Approaches for Chronic Low-Back Pain: A Pain Research Registry-Based Study. J Altern Complement Med. 2020 May;26(5):369-375. doi: 10.1089/acm.2019.0448. Epub 2020 Mar 11. PMID 32167785
• Licciardone JC, Pandya V. Prevalence and Impact of Comorbid Widespread Pain in Adults with Chronic Low Back Pain: A Registry-Based Study. J Am Board Fam Med. 2020 Jul-Aug;33(4):541-548. doi: 10.3122/jabfm.2020.04.190456. PMID 32675265
• Licciardone JC, Pandya V. Feasibility Trial of an eHealth Intervention for Health-Related Quality of Life: Implications for Managing Patients with Chronic Pain during the COVID-19 Pandemic. Healthcare (Basel). 2020 Oct 1;8(4):381. doi: 10.3390/healthcare8040381. PMID 33019676
• Licciardone JC. Demographic Characteristics Associated With Utilization of Noninvasive Treatments for Chronic Low Back Pain and Related Clinical Outcomes During the COVID-19 Pandemic in the United States. J Am Board Fam Med. 2021 Feb;34(Suppl):S77-S84. doi: 10.3122/jabfm.2021.S1.200352. PMID 33622822

Идентификаторы

NCT: NCT04853732 · #2015-169

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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