Non-Surgical Interventions for Knee Osteoarthritis

(SKOAP Trial)

Recruiting at 29 trial locations

Overseen By Claudia Campbell, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Johns Hopkins University

Must not be taking: Opioids, MAO inhibitors

Disqualifiers: Pregnancy, Severe psychiatric conditions, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1937 Participants Needed

Trial Summary

What is the purpose of this trial?

There is an urgent public health need to reduce reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA.These results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.

Research Team

Steven Cohen, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

Meets American College of Rheumatology Classification criteria for knee osteoarthritis

Exclusion Criteria

I do not have any severe health conditions that would make it unsafe for me to participate.

Severe vision or hearing impairment or serious cognitive impairment that could interfere with consent or outcome assessment

I am scheduled for a knee replacement surgery.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

8 weeks

Regular visits as per protocol

Phase 2: Treatment

Participants receive procedural interventions such as intra-articular injections or nerve procedures.

12 weeks

Regular visits as per protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of opioid use and pain.

Up to 2 years

Treatment Details

Interventions

• Best Practices
• Duloxetine
• Intra-Articular Injection
• Nerve Procedure with long acting blocks
• Nerve Procedure with nerve ablation
• Pain Coping Skills Training

Trial Overview The trial tests several non-surgical treatments to manage long-term pain and improve function in people with knee osteoarthritis. Treatments include Duloxetine (a medication), nerve procedures using either long-acting blocks or ablation techniques (nerve destruction), best practice care strategies, intra-articular injections (directly into the joint), and training to develop skills for coping with pain.

Participant Groups

Group I: Phase 1: Best Practices + Duloxetine + Pain coping skills Active Control 3 Interventions

Participants will receive Duloxetine, pain coping skills training, and a prescription for guideline-recommended treatments for knee osteoarthritis, i.e., Best Practices. Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments. Phase 1 ended enrollment on April 12, 2024.

Group II: Phase 1: Best Practices + Duloxetine Active Control 2 Interventions

Participants will receive Duloxetine and a prescription for guideline-recommended treatments for knee osteoarthritis, i.e., Best Practices. Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments. Phase 1 ended enrollment on April 12, 2024.

Group III: Phase 1: Best Practices Active Control 1 Intervention

Participants will receive a prescription for guideline-recommended treatments for knee osteoarthritis, i.e., Best Practices. Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments. Based on the pre-specified stopping rules described in Protocol section 13.2, the DSMB advised ceasing enrollment into Arm 1A (Best Practices). This recommendation was accepted by the sponsor and study investigators. Arm 1A (Best Practices) was closed on 11/29/2023.

Group IV: Phase 2: Intra-Articular Injection (HA+) Active Control 1 Intervention

Participants will receive an intra-articular injection of hyaluronic acid mixed with steroid and bupivacaine. Phase 2 ended enrollment on October 24, 2024.

Group V: Phase 2: Nerve Procedure: Long Acting Blocks Active Control 1 Intervention

Participants will receive a nerve blocking procedure, long-acting local anesthetic, and steroid injection. Phase 2 ended enrollment on October 24, 2024.

Group VI: Phase 2: Nerve Procedure: Nerve Ablation Active Control 1 Intervention

Participants will receive a nerve ablation procedure and steroid injection. Phase 2 ended enrollment on October 24, 2024.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Pacira Pharmaceuticals, Inc

Industry 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

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Collaborator

Trials

508

Recruited

1,090,000+