Clinical trial NCT03415360: Cryolesion in Treatment of Phantom Limb Pain
Official title: Percutaneous Cryoablation in the Treatment of Neuropathic Pain Post Limb Amputation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Phantom Limb Pain
Stump Neuralgia
Pain, Phantom
Keywords: cryoablation
Lead sponsor: Military Institute od Medicine National Research Institute
Sponsor class: OTHER
First posted: 2018-01-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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 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


Eligibility criteria: 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

Primary outcomes:
measure: Reduction of pain
timeFrame: T1: before cryoablation; T2: 24 hours after cryoablation; T3: 7 days after cryoablation; T4: 30 days after cryoablation; T5: 3 months after cryoablation; T6: 6 months after cryoablation.
Secondary outcomes:
measure: The quality of life (SF-36)
timeFrame: A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.
measure: The quality of life (AIS)
timeFrame: A1: before cryoablation; A2: 24 hours after cryoablation; A3: 30 days after cryoablation; A4: 6 months after cryoablation.
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Military Institute of Medicine
Study officials:
affiliation: Military Institute of Medicine
name: Dariusz Tomaszewski
role: STUDY_CHAIR
References: