Proximal Nerve Cryoablation Versus Perineuroma Cryoablation for Chronic Neuroma Pain After Combat-Related Amputation (AXON-FREEZE)
atients with combat-related amputations frequently develop chronic neuroma pain that interferes with rehabilitation, prosthesis use, mobility, sleep, and quality of life. Cryoablation is a minimally invasive treatment that produces controlled nerve injury using extreme cold. Although the freezing effect is localized around the cryoprobe, axonal interruption followed by distal Wallerian degeneration may extend functional denervation distal to the ablation site.
This study aims to compare two ultrasound-guided cryoablation strategies for chronic neuroma pain after combat-related amputation: cryoablation performed directly near the neuroma and cryoablation performed proximal to the neuroma along the affected nerve.
The study will evaluate whether proximal nerve cryoablation produces greater or longer-lasting analgesic effects compared with perineuroma cryoablation.
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. Current treatment strategies frequently provide incomplete or temporary analgesia.
Cryoablation is an ultrasound-guided minimally invasive technique that induces controlled axonal injury using extreme cold temperatures. Although the direct freezing zone extends only a few millimeters around the cryoprobe, cryo-induced axonotmesis may trigger distal Wallerian degeneration along the affected nerve pathway while preserving connective tissue structures that support potential nerve regeneration.
The optimal anatomical target for cryoablation in painful neuromas remains unclear. Cryoablation performed directly adjacent to the neuroma may interrupt local nociceptive signaling, whereas proximal nerve cryoablation may produce broader distal analgesic effects by interrupting axonal conduction proximal to the neuroma-bearing segment.
The AXON-FREEZE Trial is a prospective multicenter controlled study designed to compare proximal nerve cryoablation versus perineuroma cryoablation for chronic neuroma pain after combat-related amputation.
Participants with ultrasound-confirmed painful neuromas will undergo ultrasound-guided cryoablation using one of the two treatment strategies according to study allocation and local clinical practice. 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 cryoablation targeting strategies and evaluate whether proximal nerve cryoablation may provide stronger or longer-lasting pain relief compared with cryoablation performed adjacent to the neuroma.
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
-
-
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：
- Dmytro Dmytriiev, Phd
- 電話番号：0674309449
- メール：mddmytriiev@gmail.com
-
-
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 pain intensity ≥4/10 on Numeric Rating Scale
- Positive Tinel sign
- Ability to undergo ultrasound-guided cryoablation
- Stable analgesic regimen for at least 14 days
- Ability to provide written informed consent
Exclusion Criteria:
- Active infection at the treatment site
- Open wound preventing safe procedure
- Previous cryoablation of the target nerve within 6 months
- Neuroma surgery within 3 months
- Severe coagulopathy or anticoagulation contraindicating procedure
- Pregnancy or breastfeeding
- 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 |
|---|---|
|
実験的：Perineuroma Cryoablation
Ultrasound-guided cryoablation performed adjacent to the painful neuroma.
|
Ultrasound-guided cryoablation performed adjacent to the painful neuroma.
|
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アクティブコンパレータ：Proximal Nerve Cryoablation
Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.
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Ultrasound-guided cryoablation performed proximal to the neuroma along the affected nerve.
|
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 |
|---|---|---|
|
Change in Chronic Neuroma Pain Intensity
時間枠：Baseline to 12 weeks
|
Change in average neuroma pain intensity measured using the Numeric Rating Scale (NRS).
|
Baseline to 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
DN4 neuropathic pain score
時間枠：: Baseline to 24 weeks
|
Assessment of neuropathic pain characteristics using the Douleur Neuropathique 4 (DN4) questionnaire.
Higher scores indicate greater neuropathic pain involvement associated with chronic neuroma pain after combat-related amputation.
|
: Baseline to 24 weeks
|
協力者と研究者
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
追加の関連 MeSH 用語
その他の研究ID番号
- 10v213022026
- USRA (その他の識別子：Ukranian Society of Regional Anesthesia and Pain Therapy)
個々の参加者データ (IPD) の計画
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 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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