Non-Surgical Interventions for Knee Osteoarthritis
(SKOAP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores non-surgical options to manage knee osteoarthritis pain, aiming to reduce opioid use. It compares treatments such as medication (Duloxetine, an antidepressant), pain coping skills, injections, and nerve procedures to determine which best alleviates pain and improves daily function. Suitable candidates for this trial include individuals with consistent knee pain and signs of osteoarthritis, such as morning stiffness and pain with movement. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it excludes participants who have changed their pain medication dose within 2 weeks of starting the trial. It's best to discuss your specific medications with the study team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
A previous study found duloxetine effective for knee osteoarthritis (KOA) pain, with generally manageable side effects. However, duloxetine may cause more side effects than some other treatments.
Research has shown that injecting hyaluronic acid (a gel-like substance) directly into the joint is generally safe, with no significant increase in serious side effects.
Studies have demonstrated that nerve procedures, such as long-lasting nerve blocks, are usually safe and effective for reducing knee pain. However, safety and effectiveness can vary, and some procedures remain under study and are not yet standard practice.
Research on nerve ablation, a procedure that destroys nerve tissue to reduce pain, indicates it is usually safe and effective, though care must be taken to avoid certain nerve areas to prevent complications.
Overall, these treatments have been studied for safety in other settings. While they carry some risks, they are generally considered safe for many patients. Each treatment may have side effects, so it is important to discuss any concerns with a healthcare provider.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for knee osteoarthritis because they offer non-surgical options with potentially enhanced pain management. Unlike the standard care, which often involves NSAIDs, acetaminophen, and physical therapy, these treatments explore advanced methods like intra-articular injections of hyaluronic acid mixed with steroids and bupivacaine, which may provide longer-lasting pain relief. Additionally, nerve procedures like long-acting nerve blocks and nerve ablation target pain directly at its source, potentially offering more effective relief than traditional medications. These innovative approaches could provide new hope for those seeking alternatives to surgery and standard medications.
What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?
Research has shown that Duloxetine, which participants in this trial may receive, can reduce pain and improve knee function in people with knee osteoarthritis (KOA). However, some studies suggest that results can vary, and more detailed research is needed. In this trial, some participants will receive intra-articular injections, which have provided short-term pain relief and improved joint function. Other participants will undergo nerve treatments, such as long-lasting blocks and nerve ablation, which can significantly reduce pain and improve movement, with effects lasting from several weeks to months. Additionally, training in pain coping skills, another treatment option in this trial, effectively helps people manage pain and improve daily activities. Each treatment has shown promise, but results can differ from person to person.678910
Who Is on the Research Team?
Steven Cohen, MD
Principal Investigator
Johns Hopkins University
Are You a Good Fit for This Trial?
This trial is for individuals with knee osteoarthritis who meet the American College of Rheumatology criteria. It's not suitable for those with severe sensory impairments, cognitive issues that affect consent or assessments, scheduled joint replacements, open wounds on the knee, inability to follow study procedures, unstable medical conditions like uncontrolled diabetes or heart problems, history of total knee arthroplasty with pain only in the operated knee, untreated severe bleeding disorders or serious psychiatric conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1: Treatment
Participants receive conservative behavioral and non-opioid pharmacological treatments including Duloxetine, pain coping skills training, and guideline-recommended treatments for knee osteoarthritis.
Phase 2: Treatment
Participants receive procedural interventions such as intra-articular injections or nerve procedures.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of opioid use and pain.
What Are the Treatments Tested in This Trial?
Interventions
- Best Practices
- Duloxetine
- Intra-Articular Injection
- Nerve Procedure with long acting blocks
- Nerve Procedure with nerve ablation
- Pain Coping Skills Training
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
Pacira Pharmaceuticals, Inc
Industry Sponsor
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
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Collaborator