Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation

Sponsor
Ukrainian Society of Regional Anesthesia and Pain Therapy
Study ID
NCT07624877
Status
Not Yet Recruiting

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Conditions

  • Botulinium Toxin-A
  • Chronic Pain
  • Combat Trauma
  • Neuroma

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Botulinum toxin type A injection — DRUG
    Ultrasound-guided botulinum toxin type A injection performed for treatment of chronic neuroma pain after combat-related amputation. Two injection techniques will be evaluated: direct intraneuroma injection and perineuroma injection surrounding the neuroma. Procedures will be performed under sterile conditions using high-frequency musculoskeletal ultrasound guidance by clinicians experienced in ultrasound-guided pain interventions.

Study Details

Patients with combat-related amputations frequently experience chronic neuroma pain that may interfere with rehabilitation, prosthesis use, mobility, sleep, and quality of life. Ultrasound-guided botulinum toxin type A injection has emerged as a potential treatment option for persistent neuroma pain; however, the optimal injection technique remains unclear. This prospective multicenter study aims to compare two ultrasound-guided botulinum toxin injection techniques for chronic neuroma pain after combat-related amputation: intraneuroma injection and perineuroma injection. Participants with ultrasound-confirmed painful neuromas will undergo one of the two injection approaches based on the treating physician's clinical decision and local practice. Pain intensity, neuropathic pain characteristics, phantom limb pain, prosthesis tolerance, functional outcomes, and adverse events will be evaluated during follow-up. The goal of the study is to evaluate the feasibility, safety, and potential clinical effectiveness of intraneuroma and perineuroma botulinum toxin type A injection techniques in patients with chronic neuroma pain following combat-related amputation.

Key Dates

First listed
Jun 3, 2026
Start date
May 27, 2026
Status verified
May 2026
Primary completion
May 27, 2026
Completion
Dec 15, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intraneuroma Botulinum Toxin Type A Injection
    Ultrasound-guided direct intraneuroma injection of botulinum toxin type A for treatment of chronic neuroma pain after combat-related amputation.
  • Experimental: Perineuroma Botulinum Toxin Injection
    Ultrasound-guided perineuroma injection of botulinum toxin type A surrounding the neuroma for treatment of chronic neuroma pain after combat-related amputation.

Primary Outcome Measure

Change in chronic neuroma pain intensity [ Time Frame: Baseline to 12 weeks after injection ]

Central Contacts

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