Chronic Low Back PainPRECISIONNCT04853732
PRECISION Pain Research Registry
An observational study of Chronic Low Back Pain, run by University of North Texas Health Science Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to Dec 2030
- How long will I take part?
- 36 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Must not be pregnant
- Must not reside in an institutional facility
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Texas Health Science Center
Fort Worth, Texas, 76107
About this study
Official title: Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation
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.
Read the 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.
- Conditions
- Chronic Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Low Back Pain Cases | Not described | |
| Chronic Pain-Free Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case-Control Status
Chronic Low Back Pain Case or Chronic Pain-Free Control
Measured: Upon registry enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study startApr 2016
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 36 Months
Sponsor and investigators
- Lead sponsor
- University of North Texas Health Science Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John C Licciardone, DO, MS, MBA, Principal investigator, University of North Texas Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853732
- Sponsor's protocol ID
- #2015-169
- Acronym
- PRECISION
- Status last verified
- Jan 2024
- First submitted
- 16 Apr 2021
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30281768Licciardone 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.
PubMed 31305871Licciardone 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.
PubMed 31985765Licciardone 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.
PubMed 32076968Licciardone 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.
PubMed 32167785Licciardone 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.
PubMed 32675265Licciardone 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.
PubMed 33019676Licciardone 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.
PubMed 33622822Licciardone 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.
PubMed 33770828Licciardone 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.
PubMed 34348426Licciardone 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.
PubMed 34852185Licciardone 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.
PubMed 35679045Licciardone 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.
PubMed 35896452Schultz 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.
PubMed 35950241Licciardone 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.
PubMed 35918787
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Registry for Epidemiological, Clinical, and Interventional Studies and Innovation
- ClinicalTrials.gov ID
- NCT04853732
- Acronym / sponsor ID
- PRECISION / #2015-169
- Conditions
- Chronic Low Back Pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- University of North Texas Health Science CenterUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 21 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 36 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Low Back Pain Cases | – | – |
| Chronic Pain-Free Controls | – | – |
Who may qualify
- Ages
- 21 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Must not be pregnant
- Must not reside in an institutional facility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Case-Control Status
Time frame: Upon registry enrollment
Chronic Low Back Pain Case or Chronic Pain-Free Control
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Results publication: PubMed 30281768Licciardone 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.
- Results publication: PubMed 31305871Licciardone 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.
- Results publication: PubMed 31985765Licciardone 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.
- Results publication: PubMed 32076968Licciardone 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.
- Results publication: PubMed 32167785Licciardone 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.
- Results publication: PubMed 32675265Licciardone 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.
- Results publication: PubMed 33019676Licciardone 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.
- Results publication: PubMed 33622822Licciardone 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.
- Results publication: PubMed 33770828Licciardone 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.
- Results publication: PubMed 34348426Licciardone 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.
- Results publication: PubMed 34852185Licciardone 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.
- Results publication: PubMed 35679045Licciardone 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.
- Participant screening site (cases)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John C Licciardone, DO, MS, MBA principal investigator
University of North Texas Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain, run by University of North Texas Health Science Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cathleen Kearns, BA (817-735-0515, orcstudyoperations@unthsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Case-Control Status (time frame: Upon registry enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04853732, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024.