Cryolesion in Treatment of Phantom Limb Pain

Military Institute od Medicine National Research Institute

Status: Unknown

Conditions: Pain, Phantom; Stump Neuralgia; Phantom Limb Pain

Treatments: Procedure: cryoablation

Study type: Interventional

Funder types: Other

Identifiers

NCT03415360

681006-6

Details and patient eligibility

About

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

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

cryoablation

Other group

Description:

peripheral nerve cryoablation

Treatment:

Procedure: cryoablation