NCT05495334 · Pacira Pharmaceuticals, Inc
Innovations in Genicular Outcomes Registry
(iGOR)
What this study is about
The registry will capture forward-looking data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g.
View original scientific description
The registry will capture prospective data on patients receiving pain management for chronic pain due to knee osteoarthritis (OA) or pain optimization for knee arthroplasty due to knee OA. The OA pain therapies may include cryo nerve block, radiofrequency ablation (RFA), intra-articular (IA) corticosteroids, viscosupplementation, opioids, and others (e.g., non-steroidal anti-inflammatory drugs \[NSAIDs\]).
Interventions
PROCEDURE
Treatment for Knee OA
Pain management treatment for knee OA.
Primary outcome measures
Pain intensity and interference scores via NRS (Numeric Rating Scale)
Time frame: 18 months
NRS score from 0(being none)-10(being the worst)
Pain intensity and interference scores via BPI-sf (Brief Pain Inventory-short form)
Time frame: 18 months
Pain intensity and interference scores via BPI-sf 0 to 10, where: 0 = no pain and 10 = pain as bad as you can imagine
Opioid use via pre-and post-treatment analgesic medication use log
Time frame: 18 months
Opioid use via pre-and post-treatment analgesic medication use log
Functional status via KOOS-JR (Knee injury and Osteoarthritis Outcome Score for Joint Replacement)
Time frame: 18 months
Functional status via KOOS-JR. 0(none)-4(extreme)
Functional status via SANE (Single Assessment Numeric Evaluation)
Time frame: 18 months
Functional status via SANE. Percentage of normal (0% to 100% scale with 100% being normal)
Quality of Sleep via PROMIS-SD (PROMIS - Sleep Disturbance - Short Form 8b)
Time frame: 18 months
Quality of Sleep via PROMIS-SD. 1(Best)-5(Worst)
Adverse events related to pain therapies
Time frame: 18 months
Adverse events related to pain therapies
General HRQOL via PROMIS-10 (PROMIS GLOBAL-10)
Time frame: 18 months
General HRQOL via PROMIS-10. 1(Best)-5(Worst)
Patient Satisfaction
Time frame: 18 months
Patient satisfaction with pain management questionnaire (Patient Satisfaction Questionnaire). Two questions assessing satisfaction and benefit.
Physical therapy utilization and work productivity via PT/Work Productivity
Time frame: 18 months
Physical therapy (PT) utilization and work productivity via PT/Work Productivity (WP) questionnaire.
Emergency Department (ED) visits
Time frame: 18 months
Emergency Department (ED) visits
Reimbursement status
Time frame: 18 months
Reimbursement status
Post-operative pain scores NRS (Numeric Rating Scale)
Time frame: 18 months
Post-operative pain scores (NRS) 0(being none)-10(being the worst)
Post-operative opioid consumption (analgesic medication use log)
Time frame: 18 months
Post-operative opioid consumption (analgesic medication use log)
Length of facility stay
Time frame: 18 months
Length of facility stay
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Planned to receive treatment for knee OA pain including, but not limited to, knee injections, nerve blocking procedures, or knee arthroplasty within 60 days of screening
- Able to understand the informed consent and assessment questionnaires and have the ability to complete them in the opinion of the investigator
- Have access to a smartphone or internet access with a computer/tablet to complete the questionnaires using the registry application
Exclusion criteria
- Actively enrolled in an investigational trial that would preclude patients from receiving the site's standard of care for knee OA pain or knee arthroplasty recovery protocol
- Planning to have a surgery other than on the target knee
Where
- Phoenix, Arizona
- Irvine, California
- Los Angeles, California
- DeLand, Florida
- Alexandria, Louisiana
- New Orleans, Louisiana
- Baltimore, Maryland
- Bethesda, Maryland
- North Chelmsford, Massachusetts
- Omaha, Nebraska
- Jersey City, New Jersey
- Garden City, New York
And 7 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 23, 2026 · Source of record for eligibility and locations