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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Dmytro Dmytriiev, PhD.Professor
- 電話番号：+380674309449
- メール：mddmytriiev@gmail.com
研究場所
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Kyiv、ウクライナ、03143
- Feofaniya Clinical Hospital
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コンタクト：
- Andrii Khomenko, MD
- 電話番号：+380937635858
- メール：farmen@ukr.net
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Вінницька
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Vinnytsia、Вінницька、ウクライナ、21000
- Vinnitsya university hospital
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コンタクト：
- Дмитро Дмитрієв
- 電話番号：0674309449
- メール：mddmytriiev@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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実験的：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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in chronic neuroma pain intensity
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Neuropathic Pain Characteristics Assessed Using the painDETECT Questionnaire (PD-Q)
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Andrii Khomenko, MD、Feofaniya Clinical Hospital
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- 092026v25052026
- USRA (その他の識別子：Ukranian Society of Regional Anesthesia and Pain Therapy)
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個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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