Proximal Nerve Cryoablation Versus Perineuroma Cryoablation for Chronic Neuroma Pain After Combat-Related Amputation

NCT07618689 | Not Yet Recruiting DMC

• 2 other identifiers: 10v213022026USRA
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Neuroma; Cryoablation

Keywords

Cryoablation; neuroma pain; combat-related amputation; phantom limb pain; residual limb pain; peripheral nerve injury; Wallerian degeneration; ultrasound-guided intervention; military trauma

Outcome Measures

Primary Outcomes (1)

• Change in Chronic Neuroma Pain Intensity

  Change in average neuroma pain intensity measured using the Numeric Rating Scale (NRS).

  Baseline to 12 weeks

Secondary Outcomes (1)

• DN4 neuropathic pain score

  : Baseline to 24 weeks

Study Arms (2)

Perineuroma Cryoablation

EXPERIMENTAL

Ultrasound-guided cryoablation performed adjacent to the painful neuroma.

Procedure: Perineuroma Cryoablation

Proximal Nerve Cryoablation

ACTIVE COMPARATOR

Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.

Procedure: Proximal Nerve Cryoablation

Interventions

Perineuroma Cryoablation PROCEDURE

Ultrasound-guided cryoablation performed adjacent to the painful neuroma.

Perineuroma Cryoablation

Proximal Nerve Cryoablation PROCEDURE

Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.

Proximal Nerve Cryoablation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ukrainian Society of Regional Anesthesia and Pain Therapy: lead

Study Sites (1)

Vinnitsya university hospital

Vinnytsia, Вінницька, 21000, Ukraine

Location

MeSH Terms

Conditions

Neuroma; Phantom Limb; Peripheral Nerve Injuries; Wallerian Degeneration

Condition Hierarchy (Ancestors)

Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases; Trauma, Nervous System; Wounds and Injuries; Nerve Degeneration

Central Study Contacts

Dmytro Dmytriiev, PhD.Professor

CONTACT

+380674309449; mddmytriiev@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Professor

Study Record Dates

• First Submitted: May 23, 2026
• First Posted: June 1, 2026
• Study Start (Estimated): October 15, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Beginning 6 months after publication of the primary study results and ending 5 years after publication.

Locations

UA (1)