NCT04853732

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Apr 2016Dec 2030

Study Start

First participant enrolled

April 1, 2016

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2021

Completed
9.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

January 16, 2024

Status Verified

January 1, 2024

Enrollment Period

14.7 years

First QC Date

April 16, 2021

Last Update Submit

January 11, 2024

Conditions

Chronic Low Back Pain

Outcome Measures

Primary Outcomes (1)

  • Case-Control Status

    Chronic Low Back Pain Case or Chronic Pain-Free Control

    Upon registry enrollment

Study Arms (2)

Chronic Low Back Pain Cases

Chronic Pain-Free Controls

Eligibility Criteria

Age21 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be selected from patients seeking ongoing health care from a physician within the contiguous 48 United States or District of Columbia.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Texas Health Science Center

Fort Worth, Texas, 76107, United States

RECRUITING

Related Publications (21)

  • 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: 30281768RESULT

  • 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: 31305871RESULT

  • 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: 31985765RESULT

  • 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: 32076968RESULT

  • 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: 32167785RESULT

  • 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: 32675265RESULT

  • 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: 33019676RESULT

  • 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: 33622822RESULT

  • Licciardone JC. Impact of COVID-19 on utilization of nonpharmacological and pharmacological treatments for chronic low back pain and clinical outcomes. J Osteopath Med. 2021 Mar 29;121(7):625-633. doi: 10.1515/jom-2020-0334.

    PMID: 33770828RESULT

  • Licciardone JC, Aryal S. Patient-centered care or osteopathic manipulative treatment as mediators of clinical outcomes in patients with chronic low back pain. J Osteopath Med. 2021 Aug 3;121(10):795-804. doi: 10.1515/jom-2021-0113.

    PMID: 34348426RESULT

  • Licciardone JC. Preventing progression from chronic to widespread pain and its impact on health-related quality of life: a historical cohort study of osteopathic medical care. J Osteopath Med. 2021 Sep 23;122(1):21-29. doi: 10.1515/jom-2021-0105.

    PMID: 34852185RESULT

  • Licciardone JC, Ganta S, Goehring L, Wallace K, Pu R. Analysis of the Patient-Physician Relationship, Race, and Pain Control and Physical Function Among Adults With Chronic Low Back Pain. JAMA Netw Open. 2022 Jun 1;5(6):e2216270. doi: 10.1001/jamanetworkopen.2022.16270.

    PMID: 35679045RESULT

  • Licciardone JC, Aryal S. Nonadherence to Clinical Practice Guidelines for Opioid Prescribing in Patients with Chronic Low Back Pain: A Pain Research Registry-Based Study. J Am Board Fam Med. 2022 Jul-Aug;35(4):724-732. doi: 10.3122/jabfm.2022.04.210432.

    PMID: 35896452RESULT

  • Schultz MJ, Licciardone JC. The effect of long-term opioid use on back-specific disability and health-related quality of life in patients with chronic low back pain. J Osteopath Med. 2022 Aug 11;122(9):469-479. doi: 10.1515/jom-2021-0172. eCollection 2022 Sep 1.

    PMID: 35950241RESULT

  • Licciardone JC, McDonald H, Yablon M, Ngo W, Cunanan Garza KA, Aryal S. Optimizing chronic pain management through patient engagement with quality of life measures: a randomized controlled trial. J Osteopath Med. 2022 Aug 2;122(11):571-580. doi: 10.1515/jom-2021-0296. eCollection 2022 Nov 1.

    PMID: 35918787RESULT

  • Licciardone JC, Pandya V. Pain and functional recovery from chronic low back pain over 12 months: implications for osteopathic medicine. J Osteopath Med. 2022 Aug 24;122(12):623-630. doi: 10.1515/jom-2021-0288. eCollection 2022 Dec 1.

    PMID: 35998917RESULT

  • Licciardone JC, Beal J, Fakes N, Herron B, Jacobs C, Vasudevan A. The role of pain hypersensitivity in development of chronic widespread pain: a retrospective cohort study. Journal of Pain Management. January 2023;16(1):45-53.

    RESULT

  • Licciardone JC, Patel S, Kandukuri P, Beeton G, Nyalakonda R, Aryal S. Patient Satisfaction With Medical Care for Chronic Low Back Pain: A Pain Research Registry Study. Ann Fam Med. 2023 Mar-Apr;21(2):125-131. doi: 10.1370/afm.2949.

    PMID: 36973050RESULT

  • Licciardone JC, Moore S, Fix K, Blair LG, Ta K. Osteopathic manipulative treatment of patients with chronic low back pain in the United States: a retrospective cohort study. J Osteopath Med. 2023 Feb 3;123(5):259-267. doi: 10.1515/jom-2022-0212. eCollection 2023 May 1.

    PMID: 36732038RESULT

  • Licciardone JC, Kellerlee J, Joseph M, Mohammad MB, Kim KG, Jain J, Aryal S. The process and outcomes of chronic low back pain treatment provided by osteopathic and allopathic physicians: a retrospective cohort study. J Osteopath Med. 2023 May 25;123(8):385-394. doi: 10.1515/jom-2023-0046. eCollection 2023 Aug 1.

    PMID: 37225662RESULT

  • Licciardone JC, Miller CL, Nazzal AJ, Hernandez CT, Nguyen LH, Aryal S. Racial Disparities in Opioid Use and Lumbar Spine Surgery for Chronic Pain and in Pain and Function Over 3 Years: A Retrospective Cohort Study. J Pain. 2024 Mar;25(3):659-671. doi: 10.1016/j.jpain.2023.09.018. Epub 2023 Sep 28.

    PMID: 37777036RESULT

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Saliva, Blood

Study Officials

  • John C Licciardone, DO, MS, MBA

    University of North Texas Health Science Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Cathleen Kearns, BA

CONTACT

817-735-0515orcstudyoperations@unthsc.edu

Samantha Johnson, BS

CONTACT

817-735-5410orcstudyoperations@unthsc.edu

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

April 1, 2016

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

January 16, 2024

Record last verified: 2024-01

Locations

US(1)