Effect of ultrasound-guided small needle knife on patients with knee osteoarthritis: a randomized clinical trial.

BACKGROUND: Although ultrasound-guided small needle knife (UG-SNK) treatment combined with resistance exercise has shown benefits for knee osteoarthritis (OA) patients, evidence supporting this combination remains limited. OBJECTIVE: To evaluate the efficacy and safety of combining ultrasound-guided small needle knife treatment with resistance exercise for patients with knee osteoarthritis. METHODS: (1) Design, Setting, and Participants This was an 8-week open-label, analyst-blinded, randomized clinical trial conducted from May 2024 to October 2024. A total of 80 participants with knee osteoarthritis were recruited and randomly assigned to two groups on average: the ultrasound-guided small needle knife combined with resistance exercise (UG-SNK-RE) and the nonsteroidal anti-inflammatory drug combined with resistance exercise (NSAIDs-RE). (2) Interventions Both groups participated in resistance exercises twice daily for 4 weeks, completing 56 sessions. The NSAID group was instructed to take celecoxib (200 mg/day) as directed. The UG-SNK-RE group received ultrasound-guided small needle knife treatment once a week for 4 weeks, totaling 4 sessions. (3) Main Outcomes and Measures The primary outcome was the change in Visual Analog Scale (VAS) scores from baseline to weeks 4 and 8. Secondary outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and ultrasound measurements (patellar bursa effusion depth, synovial thickness, and thickness of the rectus femoris, vastus lateralis, vastus medialis oblique, and medial and lateral collateral ligaments). RESULTS: A total of 80 participants (mean [SD] age, 61.49 [10.5] years; 42 men [52.5%]) were included. At week 4, the UG-SNK-RE group showed a significant improvement in VAS scores, with a mean difference of -2.5 (-2.86 to -2.14). At week 4, the VAS score difference between the UG-SNK-RE and NSAIDs-RE groups was -1.0 (-1.40 to -0.61; P < 0.001). Secondary outcomes also showed significant differences. The effects of UG-SNK combined with resistance exercise persisted at the 8-week follow-up. CONCLUSION: In this randomized clinical trial, ultrasound-guided small needle knife combined with resistance exercise was more effective than NSAIDs combined with resistance exercise in improving pain, functional recovery, and muscle condition at both week 4 and week 8. These findings suggest that ultrasound-guided small needle knife treatment combined with resistance exercise is a viable alternative for managing knee osteoarthritis. TRIAL REGISTRATION: International Traditional Medicine Clinical Trial Registry: ITMCTR2024000182.