Botulinum Toxin Type A Versus Local Anesthetic Injection for Chronic Neuroma Pain After Combat-Related Amputation: A Multicenter Randomized Double-Blind 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
- 2
研究概览
简要总结
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.
详细描述
Neuroma pain is a common and disabling complication after combat-related limb amputation. Persistent neuroma pain may contribute to residual limb pain, phantom limb pain, impaired prosthesis tolerance, sleep disturbance, reduced mobility, and decreased quality of life. Conventional treatment strategies, including local anesthetic injections, often provide only temporary pain relief.
Botulinum toxin type A has emerged as a potential treatment option because of its ability to modulate peripheral nociceptive signaling, reduce neurogenic inflammation, and decrease peripheral sensitization. However, evidence regarding its efficacy in patients with combat-related amputations remains limited.
The NEUROQUIET Trial is a multicenter, randomized, double-blind clinical trial designed to compare ultrasound-guided botulinum toxin type A injection versus ultrasound-guided local anesthetic injection for persistent neuroma pain after combat-related amputation.
Eligible participants with ultrasound-confirmed painful neuroma will be randomized in a 1:1 ratio to receive either botulinum toxin type A or local anesthetic injection under ultrasound guidance. Participants, outcome assessors, and data analysts will remain blinded to treatment allocation.
Patients will undergo longitudinal follow-up for 24 weeks. Outcomes will include pain intensity, neuropathic pain characteristics, phantom limb pain, residual limb pain, prosthesis tolerance, analgesic consumption, sleep disturbance, and patient-reported global improvement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators performing outcome assessment, and data analysts will remain blinded to treatment allocation throughout the study period. Study medications will be prepared in identical syringes to maintain masking.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Combat-related limb amputation
- •Persistent neuroma pain lasting ≥3 months
- •Ultrasound-confirmed neuroma
- •Positive Tinel sign over the neuroma
- •Average pain intensity ≥4/10 on the Numeric Rating Scale (NRS)
- •Stable analgesic regimen for at least 14 days before enrollment
- •Ability to provide written informed consent
排除标准
- •Active infection at the injection site
- •Previous botulinum toxin injection within 6 months
- •Previous neuroma surgery within 3 months
- •Severe uncontrolled psychiatric disorder
- •Coagulopathy or anticoagulant therapy contraindicating injection
- •Known allergy to botulinum toxin or local anesthetics
- •Severe uncontrolled systemic disease
- •Inability to complete study follow-up or questionnaires
研究者
Dmytro Dmytriiev
MD, PhD, Professor
Ukrainian Society of Regional Anesthesia and Pain Therapy