Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04504812 | A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain | PHASE3 | COMPLETED | 1,937 | — | — | Feb 1, 2021 | Apr 8, 2025 | Apr 9, 2026 | 24 | United States |
The Modified 4-item BPI Pain scale consists of 3 items from BPI Pain Intensity and 1 item from BPI Pain Interference. This is a continuous measure that will be calculated as the average of worst, average, current knee pain, and pain upon walking. Change from baseline (BL) will be used in mITT analyses, and change from treatment will be used in per protocol analyses.
| Arm | Type | Description |
|---|---|---|
| Phase 1: Best Practices + Duloxetine | ACTIVE_COMPARATOR | 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. |
| Phase 1: Best Practices + Duloxetine + Pain coping skills | ACTIVE_COMPARATOR | 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. |
| Phase 2: Intra-Articular Injection (HA+) | ACTIVE_COMPARATOR | Participants will receive an intra-articular injection of hyaluronic acid mixed with steroid and bupivacaine. Phase 2 ended enrollment on October 24, 2024. |
| Phase 2: Nerve Procedure: Long Acting Blocks | ACTIVE_COMPARATOR | Participants will receive a nerve blocking procedure, long-acting local anesthetic, and steroid injection. Phase 2 ended enrollment on October 24, 2024. |
| Phase 2: Nerve Procedure: Nerve Ablation | ACTIVE_COMPARATOR | Participants will receive a nerve ablation procedure and steroid injection. Phase 2 ended enrollment on October 24, 2024. |
| Phase 1: Best Practices | ACTIVE_COMPARATOR | 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. |
| Name | Type | Description |
|---|---|---|
| Duloxetine | DRUG | Duloxetine is a drug that is used to improve pain and function in people with knee osteoarthritis (KOA). Duloxetine is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety disorder, fibromyalgia, and joint pain. It will be titrated up from 20 or 30mg according to a schedule provided by a study provider. |
| Intra-Articular Injection | COMBINATION_PRODUCT | Intra-Articular Injection is an injection of 3-6 milliliter (mL) hyaluronic acid (HA) mixed with 1 milliliter (mL) depo methylprednisolone (a steroid) and 2 mL 0.5% bupivacaine (an anesthetic) into the knee. |
| Nerve Procedure with long acting blocks | PROCEDURE | People assigned to receive this will have 1 milliliter (mL) of a long-acting local anesthetic (a.k.a. liposomal bupivacaine or EXPAREL) and steroid injected into the knee. |
| Nerve Procedure with nerve ablation | PROCEDURE | People assigned to receive this will have heat applied to destroy the nerve signaling pain in the knee. Steroid will be administered after the procedure to reduce the risk of neuritis. |
| Pain Coping Skills Training | BEHAVIORAL | Participants will be provided with a written manual that includes login information for the pain coping skills training website. The participants will be expected to log into the system weekly, work through the modules, and participate in skills practice. |
| Best Practices | OTHER | 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. |
Inclusion Criteria: * Knee pain score of ≥4 and ≤ 9 on the Modified 4-Item BPI Pain Scale at pre-intervention screening * Meets at least 1 of the 3 American College of Rheumatology (ACR) Classification criteria for knee osteoarthritis. ACR criteria are: 1. At least three of the following using hi...