Status:

UNKNOWN

Cryolesion in Treatment of Phantom Limb Pain

Lead Sponsor:

Military Institute od Medicine National Research Institute

Conditions:

Phantom Limb Pain

Stump Neuralgia

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 confirm...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 9 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2020

Estimated Enrollment :

50 Patients enrolled

Trial Details

Trial ID

NCT03415360

Start Date

February 9 2018

End Date

January 1 2020

Last Update

September 25 2018

Active Locations (1)

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Military Institute of Medicine

Warsaw, Poland, 04141