Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation (IN-PERI NEUROM)
Comparative Evaluation of Intraneuroma and Perineuroma Botulinum Toxin Type A Injection Techniques for Chronic Neuroma Pain After Combat-Related Amputation: A Prospective Multicenter Study
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.
研究概览
详细说明
Chronic neuroma pain is a common and disabling complication following combat-related limb trauma and amputation. Persistent neuroma pain may contribute to residual limb pain, phantom limb pain, impaired prosthesis tolerance, reduced mobility, sleep disturbance, and decreased quality of life. Ultrasound-guided botulinum toxin type A injection has emerged as a promising treatment option because of its potential effects on peripheral nociceptive signaling, neurogenic inflammation, and neuropathic pain modulation.
However, the optimal injection technique for botulinum toxin administration in painful neuromas remains unclear. Two commonly used approaches include direct intraneuroma injection and perineuroma injection surrounding the neuroma. Intraneuroma injection may provide more direct pharmacological modulation of pathological nerve tissue, whereas perineuroma injection may reduce the risk of mechanical nerve injury while still targeting peripheral sensitization mechanisms.
This prospective multicenter study is designed to evaluate the feasibility, safety, and clinical outcomes associated with intraneuroma and perineuroma ultrasound-guided botulinum toxin type A injection techniques in patients with chronic neuroma pain after combat-related amputation.
Patients with ultrasound-confirmed painful neuromas will undergo ultrasound-guided botulinum toxin type A injection using one of the two injection techniques according to local clinical practice and physician decision-making. Clinical follow-up will include assessment of neuroma pain intensity, neuropathic pain characteristics, phantom limb pain, residual limb pain, prosthesis tolerance, analgesic consumption, patient-reported improvement, and adverse events.
The study aims to improve understanding of ultrasound-guided botulinum toxin injection strategies for chronic neuroma pain and to identify potential differences in safety and clinical effectiveness between intraneuroma and perineuroma approaches in patients with combat-related amputations.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Dmytro Dmytriiev, PhD.Professor
- 电话号码：+380674309449
- 邮箱：mddmytriiev@gmail.com
学习地点
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Kyiv、乌克兰、03143
- Feofaniya Clinical Hospital
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接触：
- Andrii Khomenko, MD
- 电话号码：+380937635858
- 邮箱：farmen@ukr.net
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Вінницька
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Vinnytsia、Вінницька、乌克兰、21000
- Vinnitsya university hospital
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接触：
- Дмитро Дмитрієв
- 电话号码：0674309449
- 邮箱：mddmytriiev@gmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Age ≥18 years
- Combat-related limb amputation
- Chronic neuroma pain lasting ≥3 months
- Ultrasound-confirmed painful neuroma
- Average neuroma pain intensity ≥4/10 on the Numeric Rating Scale
- Ability to undergo ultrasound-guided injection
- Stable analgesic regimen for at least 14 days before enrollment
- Ability to provide written informed consent
Exclusion Criteria:
- Active infection at or near the injection site
- Open wound preventing safe injection
- Previous botulinum toxin injection for neuroma pain within 6 months
- Previous neuroma surgery within 3 months
- Known allergy to botulinum toxin type A
- Coagulopathy or anticoagulation contraindicating injection
- Severe uncontrolled systemic disease
- Inability to complete follow-up assessments
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
其他名称：
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实验性的：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.
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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.
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Change in chronic neuroma pain intensity
大体时间：Baseline to 12 weeks after injection
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Change in chronic neuroma pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average neuroma-related pain during the previous 7 days on a scale from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain." The change from baseline NRS score will be calculated at each follow-up assessment. Scale Information: Numeric Rating Scale (NRS) Minimum Value: 0 Maximum Value: 10 Interpretation: Higher scores indicate greater chronic neuroma pain intensity and worse clinical outcomes. Negative change from baseline indicates improvement. |
Baseline to 12 weeks after injection
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
大体时间：Baseline to 12 and 24 weeks
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Neuropathic pain characteristics will be assessed using the painDETECT Questionnaire (PD-Q), a validated self-administered questionnaire designed to identify and quantify neuropathic pain symptoms. The questionnaire evaluates sensory descriptors, pain course pattern, and pain radiation. Total scores range from -1 to 38. Scale Information: painDETECT Questionnaire (PD-Q) Minimum Value: -1 Maximum Value: 38 Interpretation: Higher scores indicate more pronounced neuropathic pain characteristics and a greater likelihood of neuropathic pain. Clinical Interpretation: ≤12 = Neuropathic pain unlikely 13-18 = Uncertain neuropathic pain component ≥19 = Neuropathic pain likely |
Baseline to 12 and 24 weeks
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Residual Limb Pain Intensity
大体时间：Baseline to 12 and 24 weeks
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Residual limb pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their average residual limb pain during the previous 7 days on a scale from 0 ("no pain") to 10 ("worst imaginable pain"). Scale Information: Numeric Rating Scale (NRS) Minimum Value: 0 Maximum Value: 10 Interpretation: Higher scores indicate greater residual limb pain intensity and worse pain outcomes. |
Baseline to 12 and 24 weeks
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Prosthesis Tolerance Assessed Using Average Daily Prosthesis Wearing Time
大体时间：Baseline, 3 months, 6 months, and 12 months after amputation or intervention.
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Prosthesis tolerance will be assessed by measuring the average daily duration of prosthesis use reported by the participant. Average daily prosthesis wearing time will be recorded as the total number of hours the prosthesis is worn during a typical day. Measurement: Average daily prosthesis wearing time Unit of Measure: Hours per day (hours/day) Minimum Value: 0 hours/day Maximum Value: 24 hours/day Interpretation: Higher values indicate better prosthesis tolerance, greater comfort during use, and improved adaptation to the prosthesis. |
Baseline, 3 months, 6 months, and 12 months after amputation or intervention.
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合作者和调查者
调查人员
- 首席研究员：Andrii Khomenko, MD、Feofaniya Clinical Hospital
出版物和有用的链接
研究记录日期
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学习开始 (估计的)
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研究完成 (估计的)
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首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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关键字
其他相关的 MeSH 术语
其他研究编号
- 092026v25052026
- USRA (其他标识符：Ukranian Society of Regional Anesthesia and Pain Therapy)
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