About this trial

Patients with combat-related amputations frequently experience persistent neuroma pain that may interfere with rehabilitation, prosthesis use, sleep, mobility, and quality of life. Current treatment options often provide only temporary relief. This study aims to compare two ultrasound-guided injection approaches for chronic neuroma pain after combat-related amputation: botulinum toxin type A and local anesthetic injection.

Participants will be randomly assigned to receive one of the two treatments. Pain intensity, neuropathic pain symptoms, phantom limb pain, prosthesis tolerance, and functional outcomes will be evaluated during follow-up visits over a 24-week period.

The goal of the study is to determine whether botulinum toxin type A provides longer-lasting pain reduction and improved functional recovery compared with local anesthetic injection in patients with chronic neuroma pain after combat-related amputation.

Eligibility criteria

Qualifiers

Age ≥18 years

Combat-related limb amputation

Persistent neuroma pain lasting ≥3 months

Ultrasound-confirmed neuroma

Disqualifiers

Active infection at the injection site

Previous botulinum toxin injection within 6 months

Previous neuroma surgery within 3 months

Severe uncontrolled psychiatric disorder

Trial design

Treatments tested in this trial

  • Botulinum Toxin Type A (BoNT-A)
  • Local Anesthetic Solution

Treatment groups

100 Participants
are divided into 2 treatment groups

Locations

2
Feofaniya Clinical Hospital03143, KyivVinnytsia Oblast, Ukraine
Vinnitsya university hospital21000, Vinnitsa Ukraine

Sponsors and collaborators

Ukrainian Society of Regional Anesthesia and Pain Therapy

Lead sponsor