Non-Surgical Interventions for Knee Osteoarthritis
(SKOAP Trial)

Recruiting in Palo Alto (17 mi)

+29 other locations

Overseen bySteven Cohen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

+6 more

Participant Groups

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.

6Treatment groups

Active Control

Group I: Phase 1: Best Practices + Duloxetine + Pain coping skillsActive Control3 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 + DuloxetineActive Control2 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 PracticesActive Control1 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 Control1 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 BlocksActive Control1 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 AblationActive Control1 Intervention

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