Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation
NCT07626983 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-06-04
Summary
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.
Conditions
- Chronic Pain Due to Injury
- Neuroma of Lower Limb
- Neural Injury
- Neuroma of Upper Limb
- Combat Related Symptoms
Interventions
- DRUG
-
Botulinum Toxin Type A (BoNT-A)
Ultrasound-guided perineuroma injection of botulinum toxin type A for treatment of persistent neuroma pain after combat-related amputation.
- DRUG
-
Local Anesthetic Solution
Ultrasound-guided perineuroma injection of local anesthetic for treatment of persistent neuroma pain after combat-related amputation.
Sponsors & Collaborators
-
Ukrainian Society of Regional Anesthesia and Pain Therapy
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-30
- Primary Completion
- 2026-12-15
- Completion
- 2026-12-15
Countries
- Ukraine
Study Locations
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