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Non-Surgical Interventions for Knee Osteoarthritis (SKOAP Trial)

Phase 3

Recruiting

Led By Steven Cohen, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Unstable medical condition that presents as an absolute or relative contraindication for participation (e.g., unstable angina, poorly controlled diabetes mellitus, end stage renal failure, automated implantable cardioverter-defibrillator that cannot be disabled before RFA)

Poorly controlled serious psychiatric condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up opioid use and pain assessed up to 2 years. pgic assessed at main outcome visit (8 and 12 weeks for phase 1 and phase 2, respectively). the treatment response categorical outcome will be analyzed separately for mitt and per- protocol analyses.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA. The results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at injection sites from intra-articular injections; skin irritation or numbness from nerve procedures; digestive issues, fatigue, mood changes from Duloxetine; and general risks associated with any medical procedure such as infection.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a serious mental health condition that is not well-managed.

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I am scheduled for a knee replacement surgery.

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I have had knee replacement surgery and feel pain in that knee.

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I have an ulcer or open wound near my knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ opioid use and pain assessed up to 2 years. pgic assessed at main outcome visit (8 and 12 weeks for phase 1 and phase 2, respectively). the treatment response categorical outcome will be analyzed separately for mitt and per- protocol analyses.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~opioid use and pain assessed up to 2 years. pgic assessed at main outcome visit (8 and 12 weeks for phase 1 and phase 2, respectively). the treatment response categorical outcome will be analyzed separately for mitt and per- protocol analyses.

This trial's timeline: 3 weeks for screening, Varies for treatment, and opioid use and pain assessed up to 2 years. pgic assessed at main outcome visit (8 and 12 weeks for phase 1 and phase 2, respectively). the treatment response categorical outcome will be analyzed separately for mitt and per- protocol analyses. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Intensity as assessed by the Modified 4-item Brief Pain Inventory (BPI) Pain Scale

Secondary study objectives

Change in Pain Intensity as assessed by the BPI

Change in Pain Interference as assessed by the BPI

Change in Physical Functioning as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

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.

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. Following the Phase 1 interim analysis in November 2023, the Data Safety and Monitoring Board and study sponsors approved formal closure of this arm per the pre-specified stopping rules.

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.

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.

Group VI: Phase 2: Nerve Procedure: Nerve AblationActive Control1 Intervention

Participants will receive a nerve ablation procedure and steroid injection.

0 / 5Eligibility criteria met