Cryoneurolysis for Knee OA
Trial question
What is the effect of cryoneurolysis in patients with chronic knee osteoarthritis pain?
Study design
Single center
Double blinded
RCT
Population
Characteristics of study participants
45.0% female
55.0% male
N = 87
87 patients (39 female, 48 male).
Inclusion criteria: patients with chronic knee osteoarthritis pain.
Key exclusion criteria: systemic inflammatory conditions; previous cryoneurolysis for the knee; receipt of hyaluronic acid injections in the past 30 days or corticosteroid injections within 3 months; structural abnormalities unrelated to osteoarthritis that affected locomotion or knee function; BMI < 18 or > 40 kg/m²; ongoing treatment for other pain conditions; pregnancy; coagulopathy; uncontrolled serious illnesses; diseases associated with adverse reactions to cold.
Interventions
N=44 cryoneurolysis (cryoneurolysis probe inserted near the target nerve under ultrasound guidance, single freeze cycle for 30 seconds at 20% effect, followed by 2.5 minutes at 60% effect).
N=43 sham procedure (mirroring of the cryoneurolysis procedure, with gas directed to a secondary probe instead at the target nerve).
Primary outcome
Reduction in 24-hours numeric rating scale pain scores at 14 days
1.9 points
1.4 points
1.9 points
1.4 points
0.9 points
0.5 points
0.0 points
Cryoneurolysis
Sham
procedure
No significant
difference ↔
No significant difference in reduction in 24-hours NRS pain scores at 14 days (1.9 points vs. 1.4 points; AD 0.49 points, 95% CI -0.3 to 1.2).
Secondary outcomes
No significant difference in reduction in 24-hours NRS pain scores at 6 months (2.5 points vs. 1.4 points; AD 1.1 points, 95% CI -0.3 to 1.9).
No significant difference in reduction in pain scores after a structured education and exercise program (2.3 points vs. 1.5 points; AD 0.8 points, 95% CI -0.1 to 1.6).
No significant difference in reduction in NRS least pain score at 14 days (1.4 points vs. 0.1 points; AD 1.2 points, 95% CI -0.5 to 2).
Safety outcomes
No significant differences in bruising, altered sensation, local pain, tingling.
Significant differences in numbness (48.8% vs. 2.3%), swelling (25.6% vs. 4.6%).
Conclusion
In patients with chronic knee osteoarthritis pain, cryoneurolysis was not superior to sham procedure with respect to reduction in 24-hours NRS pain scores at 14 days.
Reference
Niels-Peter Brøchner Nygaard, Carsten Koch-Jensen, Henrik Bjarke Vaegter et al. Efficacy of Cryoneurolysis on Chronic Pain in Patients with Knee Osteoarthritis: A Double-blinded Randomized Controlled Sham Trial. Anesthesiology. 2025 Jun 1;142(6):1114-1126.
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