Cryolesion in Treatment of Phantom Limb Pain

Percutaneous Cryoablation in the Treatment of Neuropathic Pain Post Limb Amputation

Assessment of pain intensity on the NRS. Assessment of the quality of life by SF-36 and AIS. Diagnostic/prognostic nerve block with 5 ml of 2% lidocaine under real-time ultrasound control with confirmation of the correct position of the needle using a peripheral nerve stimulator.

Reassessment of pain intensity on the NRS 30 minutes after local anesthetic block.

Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.

If pain intensity on the NRS reduced by less than 2 points, reassessment 60 minutes after local anesthetic block.

Cryoablation under real-time ultrasound control if the NRS value is reduced by ≥ 2 points.

If pain intensity on the NRS reduces by less than 2 points 60 minutes after local anesthetic block cryoablation will not be performed.

Cryoablation effect will be evaluated 24 hours, 7 days, 30 days, 3 months, 6 months post procedure.

• 24 hours after the procedure - assessment of pain intensity and quality of life
• 7 days after the procedure - assessment of pain intensity
• 30 days after the procedure - assessment of pain intensity and quality of life
• 3 months after the procedure - assessment of pain intensity
• 6 months after the procedure - assessment of pain intensity and quality of

Inclusion Criteria:

• Status post amputation of a lower or upper limb
• Pain related to amputation as determined by referring physician and investigator
• Informed consent of patient to enter the study
• Reduction of pain after the diagnostic/prognostic anesthetic block of the relevant main peripheral nerves under ultrasonography guidance in an analogous fashion to the cryoablation procedure

Exclusion Criteria:

• Pregnancy
• Active infection in the area of the planned intervention
• Blood coagulation disorders
• Immunosuppression
• Significant spinal stenosis or spinal anomalies that result in differential nerve root pressures
• Significant disease or disorder that in the opinion of the Principal Investigator would preclude the safe performance of the anesthetic block or cryoablation
• Participation in another investigational trial involving systemic administration of agents of unknown chemical composition.
• No reduction of pain after the diagnostic block of the relevant main peripheral nerves