The purpose of this study is to determine if treatment with percutaneous cryoablation yields significant differences in the evaluative criteria of Phantom Limb Syndrome (PLS).
This study aims to treat Phantom Limb Syndrome (PLS) with cryoablation of the remaining nerve stumps. The rationale is that because the pain in PLS follows the known distribution of nerves, and because the amputated nerves are known to undergo changes after the surgery that may lead to excessive "firing," that interruption of the nerve impulses will reduce patient pain.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
23
Subjects who respond to lidocaine nerve block will undergo CT guided cryoablation of the affected nerve stump with a 17g Galil Medical Ice Sphere cryoablation needle.
Under CT guidance, the corresponding nerve will be targeted with a 17g probe. Two freeze-thaw cycles will be undertaken. The probe will be removed and a final scan obtained.
Emory University Hospital
Atlanta, Georgia, United States
Feasibility of cryoablation, defined by number of participants, in which cryoablation was performed successfully
Feasibility, defined by number of participants, in which cryoablation was performed successfully
Time frame: Post-Cryoablation
Safety of cryoablation procedure, measured by the number of subjects that had cryoablation procedure events (CPEs).
Safety is measured by the number of subjects that had cryoablation procedure events (CPEs). CPEs are device- or procedure-related serious adverse events (SAE) or adverse events (AE) categorized as clinical signs or symptoms of infection (fever), hemorrhage (pain, imaging changes), nerve pain worsening, or toxicity of any kind (confusion, seizure).
Time frame: 56 days
Change in pain scores on visual analogue scale (VAS )
Change in pain score will be calculated by subtracting the day 56 pain score from the baseline pain score.The pain scores are on a continuous visual analogue scale of 0 to 100 mm. 0 mm = no pain and 100 mm = worst possible pain. The VAS is scored simply by measuring the distance, in mm, from the patient's mark to one of the ends of the line.
Time frame: Baseline, day 56
Change in quality of life, measured using Roland-Morris Disability Questionnaire (RDQ)
Quality of life will be measured using Roland-Morris Disability Questionnaire (RDQ); it is a validated measure of physical disability due to low back pain.The best score is 0 (no disability) and worst is 24 (maximum disability).
Time frame: Baseline, day 56
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