About this trial
atients with combat-related amputations frequently develop chronic neuroma pain that interferes with rehabilitation, prosthesis use, mobility, sleep, and quality of life. Cryoablation is a minimally invasive treatment that produces controlled nerve injury using extreme cold. Although the freezing effect is localized around the cryoprobe, axonal interruption followed by distal Wallerian degeneration may extend functional denervation distal to the ablation site.
This study aims to compare two ultrasound-guided cryoablation strategies for chronic neuroma pain after combat-related amputation: cryoablation performed directly near the neuroma and cryoablation performed proximal to the neuroma along the affected nerve.
The study will evaluate whether proximal nerve cryoablation produces greater or longer-lasting analgesic effects compared with perineuroma cryoablation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Combat-related limb amputation
Chronic neuroma pain lasting ≥3 months
Ultrasound-confirmed painful neuroma
Disqualifiers
Active infection at the treatment site
Open wound preventing safe procedure
Previous cryoablation of the target nerve within 6 months
Neuroma surgery within 3 months
Trial design
Parallel
Treatments tested in this trial
Perineuroma Cryoablation
Procedure/SurgeryUltrasound-guided cryoablation performed adjacent to the painful neuroma.
Proximal Nerve Cryoablation
Procedure/SurgeryUltrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.
Treatment groups
Trial outcomes
Primary outcomes
Change in Chronic Neuroma Pain Intensity
Change in average neuroma pain intensity measured using the Numeric Rating Scale (NRS).
Secondary outcomes
DN4 neuropathic pain score
Assessment of neuropathic pain characteristics using the Douleur Neuropathique 4 (DN4) questionnaire. Higher scores indicate greater neuropathic pain involvement associated with chronic neuroma pain after combat-related amputation.
Sponsors and contacts
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