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Fu's Subcutaneous Needling for Knee Osteoarthritis Pain
Published on: March 24, 2023
A Multicenter Randomized Pragmatic Trial Comparing Intra-Articular Injection, Genicular Nerve Block, and
Steven P Cohen1, Daniel O Scharfstein2, Robert W Hurley3
1Northwestern University Feinberg School of Medicine, Departments of Anesthesiology, Neurology, Physical Medicine & Rehabilitation, Psychiatry and Neurological Surgery; 259 E Erie St Ste 1400, Chicago, IL 60611.
Pain Medicine (Malden, Mass.)
|July 3, 2026
Summary
This study compares three knee osteoarthritis treatments: injections, nerve blocks, and radiofrequency ablation. SKOAP Phase 2 provides robust evidence to guide procedural interventions for chronic knee pain.
Area of Science:
- Orthopedics
- Pain Management
- Clinical Trials
Background:
- Knee osteoarthritis (KOA) causes significant pain and disability globally.
- Clinical guidelines lack consensus on escalating care after conservative management failure.
- Limited comparative data exists for procedural interventions like genicular nerve blocks (GNB) and radiofrequency ablation (GN-RFA).
Purpose of the Study:
- To compare the effectiveness of intra-articular injections, GNB, and GN-RFA for managing KOA pain.
- To generate methodologically robust evidence for procedural interventions in KOA.
- To inform clinical decision-making regarding the escalation of non-operative treatments for KOA.
Main Methods:
- Multisite, pragmatic, randomized comparative-effectiveness trial (SKOAP Phase 2) enrolling at least 900 knees.
- Randomization to image-guided intra-articular hyaluronic acid plus corticosteroid/anesthetic, GNB with liposomal bupivacaine/corticosteroid plus sham RFA, or comprehensive GN-RFA with corticosteroid injection.
- Rigorous 12-week blinding for GNB and GN-RFA groups using harmonized protocols and standardized sham procedures.
Main Results:
- Primary outcome: change in modified Brief Pain Inventory (mBPI) at 12 weeks.
- Secondary outcomes: pain interference, physical function, quality of life, and global improvement.
- Effectiveness evaluated using three prespecified estimands with advanced statistical methods accounting for trial complexities.
Conclusions:
- SKOAP Phase 2 employs a pragmatic design with rigorous sham-controlled blinding.
- The study will yield robust comparative evidence on procedural KOA management.
- Findings will directly inform guidelines on escalating non-operative interventions for KOA pain.