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Proximal Nerve Cryoablation Versus Perineuroma Cryoablation for Chronic Neuroma Pain After Combat-Related Amputation (AXON-FREEZE)

30. maj 2026 opdateret af: Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Ukraine
    • Вінницька
      • Vinnytsia, Вінницька, Ukraine, 21000
        • Vinnitsya university hospital
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Perineuroma Cryoablation
Ultrasound-guided cryoablation performed adjacent to the painful neuroma.
Procedure: Perineuroma Cryoablation
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.
Procedure: Proximal Nerve Cryoablation
Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Chronic Neuroma Pain Intensity
Tidsramme: Baseline to 12 weeks
Change in average neuroma pain intensity measured using the Numeric Rating Scale (NRS).
Baseline to 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
DN4 neuropathic pain score
Tidsramme: : 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ukrainian Society of Regional Anesthesia and Pain Therapy

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. oktober 2026

Primær færdiggørelse (Anslået)

15. oktober 2026

Studieafslutning (Anslået)

15. oktober 2026

Datoer for studieregistrering

Først indsendt

23. maj 2026

Først indsendt, der opfyldte QC-kriterier

23. maj 2026

Først opslået (Faktiske)

1. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 10v213022026
  • USRA (Anden identifikator: Ukranian Society of Regional Anesthesia and Pain Therapy)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data including demographic characteristics, ultrasound findings, neuroma pain intensity scores, DN4 neuropathic pain assessments, phantom limb pain measures, residual limb pain outcomes, prosthesis tolerance assessments, analgesic consumption, adverse events, and follow-up clinical evaluations collected during the study will be available for sharing. The study protocol, statistical analysis plan, and analytic code may also be shared upon reasonable request.

IPD-delingsadgangskriterier

Beginning 6 months after publication of the primary study results and ending 5 years after publication.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

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Kliniske forsøg med Neurom

Kliniske forsøg med Perineuroma Cryoablation

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Betingelser

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Kosttilskud

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Placeringer

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