Feasibility study with 25 patients investigating the effect of cryoneurolysis on persistent cutaneous neuropathic pain after surgery and trauma. All patients receive active treatment (cryoneurolysis). The study design is unblinded, non-randomized, non-controlled.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Cryoneurolysis
Aarhus University Hospital
Aarhus, Central Jutland, Denmark
RECRUITINGSuccess of cryoneurolysis
Frequency of patients with \> 50% reduction of neuropathic pain
Time frame: 1 hour after cryoneurolysis
Axonal loss estimated before cryoneurolysis
Time frame: Maximum one year prior to the cryoneurolysis procedure
Hyperalgesia for pinprick
Visual Analogue Scale (VAS) score (0-100)
Time frame: 1 hour after cryo procedure compared to baseline
Allodynia for brush
VAS score (0-100)
Time frame: 1 hour after cryo procedure compared to baseline
Frequency of NRS score < 4
Numeric Rating Scale (NRS) score (0-10)
Time frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Pain score
NRS score (0-10)
Time frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure
Duration of freedom of pain (number of days after the cryoneurolysis procedure)
NRS \< 4
Time frame: Maximum follow-up until 12 months after cryoneurolysis procedure
Change of neuropathic pain score DN-4
DN-4 = Douleur Neuropathique en 4 Questions
Time frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Patient satisfaction at completion of cryo procedure
NRS score (0-10)
Time frame: From skin insertion of cryo probe to withdrawal of cryo probe
Change in muscle strength of relevant muscle groups
Handheld dynamometer
Time frame: 1 hour after cryoneurolysis compared to baseline
Procedure time for cryoneurolysis
Time frame: From skin insertion of cryo probe to withdrawal of cryo probe
Pain related medication
Time frame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
PGIC
Patient Global Impression of Change
Time frame: 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure
Adverse events
Time frame: 1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure