Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2018-02-09
2020-01-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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cryoablation
peripheral nerve cryoablation
cryoablation
cryoablation of nerve responsible for phantom limb pain
Interventions
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cryoablation
cryoablation of nerve responsible for phantom limb pain
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Military Institute od Medicine National Research Institute
OTHER
Responsible Party
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Dariusz Tomaszewski
Adjunct professor
Principal Investigators
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Dariusz Tomaszewski
Role: STUDY_CHAIR
Military Institute of Medicine
Locations
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Military Institute of Medicine
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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681006-6
Identifier Type: -
Identifier Source: org_study_id
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