Ultrasound-guided Percutaneous Cryoneurolysis to Treat Chronic Postamputation Phantom Limb Pain: A Multicenter Randomized Controlled Trial
Primary result · Change in phantom pain intensity (decrease)Result — go to the resultEstimated difference −0.1 95% CI −1.0 to 0.7Authors' conclusion
Percutaneous cryoneurolysis did not decrease chronic lower extremity phantom limb pain 4 months after treatment.
Study context
- Population
- Patients with a lower-limb amputation and established phantom pain
- Participants
- 71 vs 73
- Comparison
- Ultrasound-guided percutaneous cryoneurolysis vs sham treatment
- Cryoneurolysisn = 71
- Shamn = 73reference
- Primary endpoint
- Change in average phantom pain intensity from baseline (NRS 0 to 10)
- Follow-up
- 4 months
Methodological detailsmulticentre, sham-controlled, masked, Optional crossover treatment offered after 4 months
- Multicentre
- Sham-controlled
- Masked
- Optional crossover treatment offered after 4 months
Primary result
Change in phantom pain intensity (decrease)
Estimated difference
−0.1
95% CI −1.0 to 0.7
P = 0.759
Change by group
Cryoneurolysis
0.5
median · IQR −0.5–3.0
Sham
0
median · IQR 0–3
Cryoneurolysis vs Sham
estimated difference −0.1 (95% CI −1.0 to 0.7); P = 0.759
As reported in the abstract
Secondary outcomes
Median
| Outcome | Cryoneurolysis | Sham |
|---|---|---|
| Pretreatment phantom pain scores · baseline | 5.0 (IQR 4.0–6.0) | 5.0 (IQR 4.0–7.0) |
Pretreatment phantom pain scores · baseline
- Similar in both groups
Secondary endpoints
- No inferences drawn per statistical gatekeeping protocol
Safety
- Serious adverse event after protocol deviation (femoral nerve cryolesion below inguinal ligament): quadriceps weakness, possibly a fall and clavicle fracture
- 1
Original publication
Ultrasound-guided Percutaneous Cryoneurolysis to Treat Chronic Postamputation Phantom Limb Pain: A Multicenter Randomized Controlled Trial. Anesthesiology. Published 10 November 2022. doi:10.
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