Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection
Not yet recruitingNot applicableNCT07431944
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Neuroma-related pain is a frequent and disabling condition after limb trauma and amputation. Available treatments often provide short-lasting or insufficient analgesia. The SILENCE-NEUROMA Trial is a multicenter, randomized, double-blind, active-controlled study designed to compare the efficacy and safety of botulinum toxin type A versus local anesthetic injection for the treatment of neuroma-related pain. The primary outcome is pain reduction at 8 weeks after treatment.
Study details
- Official title
- SILENCE-NEUROMA Trial: Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection in a Randomized Controlled Trial
- Conditions
- Pain Management
- Pain
- Phantom Limb Pain
- Phantom Limb Pain After Amputation
- Interventions
- Drug: Botulinium toxin type A injection
- Drug: Local Anesthesia
- Sponsor
- Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)
- Start date
- 2026-02-15
- Primary completion
- 2026-02-15
- Sex
- All
- Age range
- from 18 Years to 50 Years
- Results posted
- No results posted in this snapshot
- Countries
- Ukraine
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age ≥18 years * History of limb trauma and/or limb amputation at least 3 months prior to enrollment * Clinical diagnosis of neuroma-related pain with focal tenderness and positive - - Tinel sign * Imaging confirmation of neuroma by ultrasound or MRI * Average pain intensity ≥4 on a 0-10 Numerical Rating Scale (NRS) during the week prior to screening * Stable analgesic regimen for at least 14 days prior to enrollment * Ability to provide written informed consent Exclusion Criteria: * Chronic pain condition unrelated to neuroma that predominates clinical symptoms * infection at or near the planned injection site * Known neuromuscular junction disorders (e.g., myasthenia gravis) * Pregnancy or breastfeeding * Botulinum toxin treatment within the previous 4-6 months * Planned surgical neuroma revision during the study period * allergy or hypersensitivity to botulinum toxin or local anesthetics
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07431944