Proximal Nerve Cryoablation Versus Perineuroma Cryoablation for Chronic Neuroma Pain After Combat-Related Amputation (AXON-FREEZE)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Chronic neuroma pain is a common and disabling complication following combat-related limb trauma and amputation. Persistent neuroma pain may contribute to residual limb pain, phantom limb pain, impaired prosthesis tolerance, reduced mobility, sleep disturbance, and decreased quality of life. Current treatment strategies frequently provide incomplete or temporary analgesia.
Cryoablation is an ultrasound-guided minimally invasive technique that induces controlled axonal injury using extreme cold temperatures. Although the direct freezing zone extends only a few millimeters around the cryoprobe, cryo-induced axonotmesis may trigger distal Wallerian degeneration along the affected nerve pathway while preserving connective tissue structures that support potential nerve regeneration.
The optimal anatomical target for cryoablation in painful neuromas remains unclear. Cryoablation performed directly adjacent to the neuroma may interrupt local nociceptive signaling, whereas proximal nerve cryoablation may produce broader distal analgesic effects by interrupting axonal conduction proximal to the neuroma-bearing segment.
The AXON-FREEZE Trial is a prospective multicenter controlled study designed to compare proximal nerve cryoablation versus perineuroma cryoablation for chronic neuroma pain after combat-related amputation.
Participants with ultrasound-confirmed painful neuromas will undergo ultrasound-guided cryoablation using one of the two treatment strategies according to study allocation and local clinical practice. Clinical follow-up will include assessment of neuroma pain intensity, neuropathic pain characteristics, phantom limb pain, residual limb pain, prosthesis tolerance, analgesic consumption, patient-reported improvement, and adverse events.
The study aims to improve understanding of cryoablation targeting strategies and evaluate whether proximal nerve cryoablation may provide stronger or longer-lasting pain relief compared with cryoablation performed adjacent to the neuroma.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Dmytro Dmytriiev, PhD.Professor
- Telefonnummer: +380674309449
- E-post: mddmytriiev@gmail.com
Studieorter
-
-
Вінницька
-
Vinnytsia, Вінницька, Ukraina, 21000
- Vinnitsya university hospital
-
Kontakt:
- Dmytro Dmytriiev, Phd
- Telefonnummer: 0674309449
- E-post: mddmytriiev@gmail.com
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Age ≥18 years
- Combat-related limb amputation
- Chronic neuroma pain lasting ≥3 months
- Ultrasound-confirmed painful neuroma
- Average pain intensity ≥4/10 on Numeric Rating Scale
- Positive Tinel sign
- Ability to undergo ultrasound-guided cryoablation
- Stable analgesic regimen for at least 14 days
- Ability to provide written informed consent
Exclusion Criteria:
- 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
- Severe coagulopathy or anticoagulation contraindicating procedure
- Pregnancy or breastfeeding
- Severe uncontrolled systemic disease
- Inability to complete follow-up assessments
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Perineuroma Cryoablation
Ultrasound-guided cryoablation performed adjacent to the painful neuroma.
|
Ultrasound-guided cryoablation performed adjacent to the painful neuroma.
|
|
Aktiv komparator: Proximal Nerve Cryoablation
Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.
|
Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Chronic Neuroma Pain Intensity
Tidsram: Baseline to 12 weeks
|
Change in average neuroma pain intensity measured using the Numeric Rating Scale (NRS).
|
Baseline to 12 weeks
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
DN4 neuropathic pain score
Tidsram: : Baseline to 24 weeks
|
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.
|
: Baseline to 24 weeks
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Smärta
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Sår och skador
- Postoperativa komplikationer
- Patologiska processer
- Neoplasmer
- Neuromuskulära sjukdomar
- Sjukdomar i det perifera nervsystemet
- Neoplasmer efter histologisk typ
- Neurobehavioral manifestationer
- Neoplasmer, nervvävnad
- Trauma, nervsystemet
- Neoplasmer i nervslidan
- Perceptuella störningar
- Smärta, postoperativt
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Nervdegeneration
- Neurom
- Perifera nervskador
- Fantomlem
- Wallerian Degeneration
Andra studie-ID-nummer
- 10v213022026
- USRA (Annan identifierare: Ukranian Society of Regional Anesthesia and Pain Therapy)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
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