Clinical trial · Interventional
Proximal Nerve Cryoablation Versus Perineuroma Cryoablation for Chronic Neuroma Pain After Combat-Related Amputation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cryoablation | — | UNRESOLVED | — |
| Neuroma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Perineuroma Cryoablation | Procedure | — | UNRESOLVED |
| Proximal Nerve Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Perineuroma Cryoablation
- description
- Ultrasound-guided cryoablation performed adjacent to the painful neuroma.
- interventionNames
- Procedure: Perineuroma Cryoablation
- type
- ACTIVE_COMPARATOR
- label
- Proximal Nerve Cryoablation
- description
- Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.
- interventionNames
- Procedure: Proximal Nerve Cryoablation
Primary outcomes (1)
- measure
- Change in Chronic Neuroma Pain Intensity
- timeFrame
- Baseline to 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available