NeuromaAXON-FREEZENCT07618689
Proximal Nerve Cryoablation Versus Perineuroma Cryoablation for Chronic Neuroma Pain After Combat-Related Amputation
A study testing Perineuroma Cryoablation and Proximal Nerve Cryoablation in people with Neuroma and Cryoablation, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 1 site in Ukraine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Neuroma, Cryoablation
- What is being tested?
- Perineuroma Cryoablation and Proximal Nerve Cryoablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUkraine
- Study dates
- 23 May 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- Ability to undergo ultrasound-guided cryoablation
- Stable analgesic regimen for at least 14 days
- Ability to provide written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Neuroma, Cryoablation
- Being tested
- Perineuroma Cryoablation, Proximal Nerve Cryoablation
- Keywords
- Cryoablation, neuroma pain, combat-related amputation, phantom limb pain, residual limb pain, peripheral nerve injury, Wallerian degeneration, ultrasound-guided intervention, military trauma
- Medical subject headings
- Neuroma, Phantom Limb, Peripheral Nerve Injuries, Wallerian Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perineuroma CryoablationProcedure or surgery
Ultrasound-guided cryoablation performed adjacent to the painful neuroma.
Proximal Nerve CryoablationProcedure or surgery
Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.
| Study group | Role | What they receive |
|---|---|---|
| Perineuroma Cryoablation | Experimental | Ultrasound-guided cryoablation performed adjacent to the painful neuroma. Receives: Procedure: Perineuroma Cryoablation |
| Proximal Nerve Cryoablation | Active comparator | Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve. Receives: Procedure: Proximal Nerve Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Chronic Neuroma Pain Intensity
Change in average neuroma pain intensity measured using the Numeric Rating Scale (NRS).
Measured: Baseline to 12 weeks
Secondary outcomes (1)
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.
Measured: : Baseline to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start23 May 2026
- Primary completion15 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuromaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain Therapy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dmytro Dmytriiev, Ukrainian Society of Regional Anesthesia and Pain Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07618689
- Sponsor's protocol ID
- 10v213022026
- Other IDs
- USRA
- Acronym
- AXON-FREEZE
- Status last verified
- Oct 2026
- First submitted
- 23 May 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proximal Nerve Cryoablation Versus Perineuroma Cryoablation for Chronic Neuroma Pain After Combat-Related Amputation
- ClinicalTrials.gov ID
- NCT07618689
- Acronym / sponsor ID
- AXON-FREEZE / 10v213022026
- Conditions
- Neuroma, Cryoablation
- Keywords
- Cryoablation, neuroma pain, combat-related amputation, phantom limb pain, residual limb pain, peripheral nerve injury, Wallerian degeneration, ultrasound-guided intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ukrainian Society of Regional Anesthesia and Pain TherapyUniversity, hospital or other
- Study start
- 23 May 2026 (actual)
- Primary completion
- 15 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perineuroma Cryoablation | Experimental | Procedure: Perineuroma CryoablationUltrasound-guided cryoablation performed adjacent to the painful neuroma. |
| Proximal Nerve Cryoablation | Active comparator | Procedure: Proximal Nerve CryoablationUltrasound-guided cryoablation performed proximal to the neuroma along the affected nerve. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perineuroma CryoablationUltrasound-guided cryoablation performed adjacent to the painful neuroma. | Procedure or surgery | Perineuroma Cryoablation |
| Proximal Nerve CryoablationUltrasound-guided cryoablation performed proximal to the neuroma along the affected nerve. | Procedure or surgery | Proximal Nerve Cryoablation |
Primary outcome
Change in Chronic Neuroma Pain Intensity
Time frame: Baseline to 12 weeks
Change in average neuroma pain intensity measured using the Numeric Rating Scale (NRS).
1 secondary outcome
DN4 neuropathic pain score
Time frame: : Baseline to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perineuroma Cryoablation and Proximal Nerve Cryoablation in people with Neuroma and Cryoablation, run by Ukrainian Society of Regional Anesthesia and Pain Therapy at 1 site in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Chronic Neuroma Pain Intensity (time frame: Baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.