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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUkrainian Society of Regional Anesthesia and Pain Therapy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Combat-related limb amputation

Chronic neuroma pain lasting ≥3 months

Ultrasound-confirmed painful neuroma

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Perineuroma Cryoablation

    Procedure/Surgery

    Ultrasound-guided cryoablation performed adjacent to the painful neuroma.

  • Proximal Nerve Cryoablation

    Procedure/Surgery

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Perineuroma CryoablationExperimental treatment 1 intervention
Group B: Proximal Nerve CryoablationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Chronic Neuroma Pain Intensity

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

Time frame
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.

Time frame
: Baseline to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: