An interventional study of Botulinium toxin type A injection and Local Anesthesia in Pain Management, Pain and Phantom Limb Pain, sponsored by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans). Not yet recruiting at 1 site in Ukraine. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) · Not applicable, Interventional, and Treatment
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.
Neuroma pain following limb trauma or amputation is characterized by focal neuropathic pain, trigger-point tenderness, and significant functional impairment. Local anesthetic injections are commonly used for diagnostic and therapeutic purposes but typically provide only transient relief. Botulinum toxin type A has demonstrated analgesic properties through inhibition of neurotransmitter release and neurogenic inflammation, potentially offering longer-lasting pain relief.
This multicenter, randomized, double-blind, active-controlled trial will enroll adults with clinically and imaging-confirmed neuroma-related pain persisting for at least 3 months after limb trauma or amputation. Participants will be randomized in a 1:1 ratio to receive either ultrasound-guided botulinum toxin type A injection or ultrasound-guided local anesthetic injection using an identical technique and volume.
Participants will be followed for 24 weeks. Pain intensity will be assessed using a numerical rating scale at predefined intervals. Secondary outcomes include responder rates, neuropathic pain characteristics, pain interference, functional outcomes, analgesic consumption, durability of pain relief, and safety. The study aims to provide high-quality evidence to guide interventional pain management strategies for neuroma-related pain.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 100 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans) is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Compared within Phantom Limb, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pain. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single ultrasound-guided perineural injection of botulinum toxin type A (100 units diluted in 2.0 mL saline) administered around the confirmed neuroma using a standardized grid injection technique.
Drug: Botulinium toxin type A injection
Single ultrasound-guided perineural injection of local anesthetic (ropivacaine 0.2%, 2.0 mL or bupivacaine 0.25%, 2.0 mL) administered around the confirmed neuroma using the identical technique and volume.
Drug: Local Anesthesia
A single ultrasound-guided perineural injection of botulinum toxin type A (100 units diluted in 2.0 mL sterile normal saline) administered circumferentially around the imaging-confirmed neuroma using a standardized grid injection technique. The procedure is performed under sterile conditions with real-time ultrasound visualization to ensure accurate perineural placement. No additional corticosteroids or anesthetics are co-administered.
A single ultrasound-guided perineural injection of local anesthetic (ropivacaine 0.2%, 2.0 mL or bupivacaine 0.25%, 2.0 mL) administered circumferentially around the imaging-confirmed neuroma using the identical injection technique and volume as the experimental arm. The procedure is performed under sterile conditions with real-time ultrasound guidance. No corticosteroids are administered.
Change in neuroma-related pain intensity from baseline to Week 8 measured using the 0-10 Numeric Rating Scale (NRS)
Description Neuroma-related pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst imaginable pain. The outcome measure is the mean change in NRS score from baseline (pre-injection assessment) to Week 8 following injection. Higher NRS scores indicate greater pain intensity. Negative values reflect improvement (pain reduction). Between-group differences (botulinum toxin type A versus local anesthetic) will be analyzed.
Time frame: Baseline (prior to injection) and Week 8 (56 ± 7 days) after injection
Plan to share: No — Individual participant data (IPD) will not be publicly shared due to patient privacy considerations and the sensitive nature of trauma-related clinical data. De-identified data may be made available upon reasonable request and approval by the study steering committee under a formal data use agreement.
Start is estimated for Feb 2026; primary completion for Feb 2026, 0 months later.
Of 61 non-industry interventional studies with no phase under Phantom Limb, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 0 months is below that.
Counting every sponsor, half of 64 studies reached it within 34 months; a quarter within 13 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Charitable Organisation Charitable Fund Superhumans (Co Cf Superhumans)