SILENCE-NEUROMA Trial: Silencing Neuroma Pain-Botulinum Toxin Versus Local Anesthetic Injection in a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in neuroma-related pain intensity from baseline to Week 8 measured using the 0-10 Numeric Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Botulinum Toxin Type A
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.
干预措施: Botulinium toxin type A injection (Drug)
Local Anesthetic (Active Control)
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.
干预措施: Local Anesthesia (Drug)
结局指标
主要结局
Change in neuroma-related pain intensity from baseline to Week 8 measured using the 0-10 Numeric Rating Scale (NRS)
时间窗: Baseline (prior to injection) and Week 8 (56 ± 7 days) after injection
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.
次要结局
未报告次要终点