Pain Management Treatments for Knee Osteoarthritis

(iGOR Trial)

Recruiting at 10 trial locations

Overseen By Kate Fasel, BSN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Pacira Pharmaceuticals, Inc

Disqualifiers: Other surgery, Investigational trial, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

4000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to gather information on different treatments for managing chronic knee pain caused by osteoarthritis (OA) or to optimize pain relief after knee replacement surgery. The treatments under study include nerve blocks, radiofrequency ablation, corticosteroid injections, and various pain relievers. Individuals with knee OA planning to receive any of these treatments within the next 60 days might be suitable candidates. Participants must be comfortable using a smartphone or computer to complete questionnaires. As a Phase 2 trial, this research measures the effectiveness of these treatments in an initial, smaller group, allowing participants to contribute to advancements in pain management.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that several treatments for knee osteoarthritis (OA) pain are promising in terms of safety. For cryo nerve block and radiofrequency ablation (RFA), studies suggest these treatments are generally well-tolerated, with only minor side effects like temporary numbness or discomfort in some patients.

Intra-articular (IA) corticosteroids are also commonly used for knee OA. They are generally safe but may cause mild side effects such as swelling or a brief increase in pain at the injection site. A doctor should monitor long-term use.

Viscosupplementation, which involves injecting a gel-like fluid into the knee, is another option. It is considered safe, with most patients experiencing only mild, short-term swelling or pain at the injection site.

Opioids present more significant safety concerns due to the risk of addiction and side effects like dizziness or constipation. Doctors usually prescribe them at the lowest effective dose and for the shortest time possible to minimize risks.

Non-steroidal anti-inflammatory drugs (NSAIDs) are widely used for pain relief. They are well-tolerated by most people but can cause stomach upset or, in rare cases, more serious issues like ulcers or kidney problems, especially with long-term use.

Overall, these treatments have been studied extensively and shown to be relatively safe. Patients should always discuss their specific situations with their doctors to weigh the benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to discover innovative ways to manage knee osteoarthritis (OA) pain. Unlike current treatments that often rely on medications like NSAIDs or corticosteroid injections to alleviate symptoms, this trial is exploring unique approaches to pain management directly targeting the knee. The focus is on understanding the outcomes of these novel methods, potentially leading to more effective and tailored pain relief options for patients with knee OA. This could revolutionize how we approach knee OA treatment and improve quality of life for many suffering from this condition.

What evidence suggests that this trial's treatments could be effective for knee OA pain?

Research has shown that several treatments can help manage knee osteoarthritis (OA) pain. In this trial, participants will receive a specific treatment for knee OA. Cryo nerve block and radiofrequency ablation (RFA) target and block pain signals from the affected nerves, providing relief. Injecting corticosteroids directly into the knee joint reduces inflammation and pain. Viscosupplementation, which involves injecting a lubricating fluid into the knee, improves movement and reduces pain. Exercise therapies, such as strengthening and flexibility exercises, have effectively improved pain, function, and quality of life. Additionally, combining hyaluronic acid with platelet-rich plasma has shown promise in reducing stiffness and improving physical function. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive various pain management therapies for knee osteoarthritis, including cryo nerve block, radiofrequency ablation, intra-articular corticosteroids, and others

18 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of opioid use, functional status, pain intensity, and patient satisfaction

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Treatment for Knee OA

How Is the Trial Designed?

Group I: All participants Experimental Treatment 1 Intervention

Eligible and enrolled subjects with knee OA pain who require treatment on the target knee as a part of pain management.

Who Is Running the Clinical Trial?

Pacira Pharmaceuticals, Inc

Lead Sponsor

Trials

142

Recruited

14,300+

Headquarters

Tampa, USA

Known For

Non-opioid Pain Management

Top Products

Exparel, Zilretta, iovera

Dr. Jonathan Slonin

Pacira Pharmaceuticals, Inc

Chief Medical Officer since 2020

BSc in Biomedical Engineering and MD from University of Miami, MBA from George Washington University

Frank D. Lee

Pacira Pharmaceuticals, Inc

Chief Executive Officer since 2024

BSc in Chemical Engineering from Vanderbilt University, MBA from Wharton Graduate School of Business

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38707059/

Effectiveness of Rehabilitation for Osteoarthritis of the Knee Our results suggested that exercise therapies, including muscle-strengthening, aerobic, flexibility, and mind-body exercises, are likely to be effective for ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0324864

A network meta-analysis based on randomized clinical trials The findings suggest that knee brace may be the most recommended therapeutic option for the knee osteoarthritis, followed by hydrotherapy and exercise.

3. bmj.com bmj.com/content/391/bmj-2025-085242

systematic review and network meta-analysis The findings demonstrated that exercise was effective at improving pain, function, gait performance, and quality of life in individuals with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11790583/

Recent advances in the management of knee osteoarthritis This review overviews current therapeutic options for knee OA pain, focusing on their efficacy, safety, and potential roles in clinical practice.

5. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-020-00426-1

Comparative efficacy of treatments for patients with knee ... Hyaluronic acid combined with platelet-rich plasma showed the best efficacy in improving stiffness, physical function, and total scores.

6. aaos.org aaos.org/globalassets/quality-and-practice-resources/osteoarthritis-of-the-knee/oak3cpg.pdf

Management of Osteoarthritis of the Knee (Non-Arthroplasty) Three prospective randomized controlled trials compared bracing to control groups for treatment of symptomatic OA of the knee joint and found ...

7. bmcmusculoskeletdisord.biomedcentral.com bmcmusculoskeletdisord.biomedcentral.com/articles/10.1186/s12891-019-2525-0

Osteoarthritis- a systematic review of long-term safety ... This systematic review aims to appraise the current evidence for the long-term (≥12 months) safety of common treatments for knee osteoarthritis (KOA).

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9971280/

Genicular artery embolization for treatment of knee ... Limited evidence suggests that GAE is a safe procedure that confers improvement in knee OA symptoms at established MCID thresholds.