Nygaard Niels-Peter Brøchner, Koch-Jensen Carsten, Vaegter Henrik Bjarke, Wedderkopp Niels, Blichfeldt-Eckhardt Morten, Gram Bibi
Department of Endocrinology, University Hospital of Southern Denmark, Esbjerg Denmark; Department of Neurology, University Hospital of Southern Denmark, Esbjerg, Denmark; Department of Regional Health Research, University of Southern Denmark, Odense, Denmark.
Department of Regional Health Research, University of Southern Denmark, Odense, Denmark; Department of Neurology, University Hospital of Southern Denmark, Esbjerg, Denmark.
Anesthesiology. 2025 Jun 1;142(6):1114-1126. doi: 10.1097/ALN.0000000000005396. Epub 2025 Jan 30.
The objective was to investigate whether cryoneurolysis was superior to sham in reducing pain intensity in patients with chronic knee osteoarthritis. The hypothesis was that cryoneurolysis is an effective and safe therapy to reduce chronic pain in patients with knee osteoarthritis.
The study was randomized, double blind, and sham controlled. A total of 87 patients with chronic knee osteoarthritis were randomized to either cryoneurolysis or a sham procedure, followed by an exercise program. The target nerves, anterior femoral cutaneous nerve and infrapatellar branch of the saphenous nerve were identified using transcutaneous electrical nerve stimulation, and cryoneurolysis was performed with ultrasound guidance. The primary outcome was the difference in average pain at 14 days after intervention between the cryoneurolysis and sham group.
For the intention-to-treat analysis, no difference was observed for the primary outcome (0.49; 95% CI, -0.3 to 1.2; P = 0.198). Both groups showed a significant reduction in pain scores 14 days after intervention (cryoneurolysis: -1.9; 95% CI, -2.4 to -1.3; and sham: -1.4; 95% CI, -1.9 to -0.8). At 6-month follow-up, a significant reduction in pain was observed in the cryoneurolysis group compared to the sham group (1.1; 95% CI, 0.3 to 1.9; P = 0.009). Cryoneurolysis was well tolerated, with minor, transient adverse effects.
This study did not show a clinically relevant reduction in pain after intervention comparing cryoneurolysis and sham. Further studies are needed.
目的是研究冷冻神经溶解术在减轻慢性膝骨关节炎患者疼痛强度方面是否优于假手术。假设是冷冻神经溶解术是一种有效且安全的治疗方法，可减轻膝骨关节炎患者的慢性疼痛。
该研究为随机、双盲且有假手术对照。总共87例慢性膝骨关节炎患者被随机分为冷冻神经溶解术组或假手术组，随后进行运动计划。使用经皮电刺激神经来识别目标神经，即股前皮神经和隐神经髌下支，并在超声引导下进行冷冻神经溶解术。主要结局是冷冻神经溶解术组和假手术组干预后14天平均疼痛的差异。
在意向性分析中，未观察到主要结局有差异（0.49；95%可信区间，-0.3至1.2；P = 0.198）。两组在干预后14天疼痛评分均显著降低（冷冻神经溶解术组：-1.9；95%可信区间，-2.4至-1.3；假手术组：-1.4；95%可信区间，-1.9至-0.8）。在6个月随访时，与假手术组相比，冷冻神经溶解术组疼痛显著降低（1.1；95%可信区间，0.3至1.9；P = 0.009）。冷冻神经溶解术耐受性良好，不良反应轻微且短暂。
该研究未显示冷冻神经溶解术与假手术相比在干预后疼痛有临床相关程度的减轻。需要进一步研究。
