Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-08 @ 5:07 AM
Study NCT ID:
NCT03415360
Status:
UNKNOWN
Last Update Posted:
2018-09-25
First Post:
2018-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryolesion in Treatment of Phantom Limb Pain
Sponsor:
Military Institute od Medicine National Research Institute
Organization:
Study Overview
Official Title:
Percutaneous Cryoablation in the Treatment of Neuropathic Pain Post Limb Amputation
Status:
UNKNOWN
Status Verified Date:
2018-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: