Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain
Monopolar Basivertebral Nerve Ablation for Axial Low Back Pain - Single-Arm Proof-of-Concept Study
調査の概要
詳細な説明
Determination of efficacy and safety of Monopolar Basivertebral Nerve Ablation (BVNA) for Axial Low Back Pain treatment, including the method optimization.
Description of Clinical State:
The basivertebral nerve is a small nerve (or rather a nerve fiber) located within the vertebral bodies, responsible for transmitting pain signals from a degenerated disc. Basivertebral nerve ablation is a minimally invasive procedure consisting of the interruption of the basivertebral nerve fibers that conduct pain.
Description of interventional procedures:
The BVNA procedure is performed under sterile conditions in an interventional suite by an experienced physician under fluoroscopic (X-ray) guidance. Following local anesthesia of the skin and subcutaneous tissue, a working instrument (cannula) is inserted into the affected vertebral body, guided by the patient's individual anatomy and preoperative Magnetic Resonance Imaging (MRI) planning. Subsequently, a radiofrequency electrode is introduced into the central part of the vertebral body. Through this electrode, targeted thermal energy is applied, leading to the interruption of pain signal transmission from the basivertebral nerve. Both the temperature and the duration of the application are strictly controlled. The patient remains conscious or under light sedation throughout the procedure and is continuously monitored and questioned regarding any discomfort, particularly pain or sensations of heat. Upon completion of the procedure, the electrode and the working instrument are removed, the puncture site is treated with a sterile dressing, and the patient is typically discharged to home care after a brief postoperative observation period. During the follow-up period, the patient will be asked to complete standardized questionnaires (Numeric Rating Scale (NRS) for Pain; Pain, Enjoyment of Life, and General Activity (PEG) Assessment; Global Rating of Change (GRC); The Oswestry Disability Index (ODI); EQ-5D Standardized Questionnaire used to measure Health-related Quality of Life) assessing pain intensity, functional limitations, and quality of life at intervals of 6 weeks, and 3, 6, and 12 months post-procedure, and long-term (24 months and beyond) depending on capacity. The follow-up also includes a control MRI scan approximately 6 months after the procedure.
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：Michal Matias, MD, FIPP
- 電話番号：+420602246127
- メール：matias@europainclinics.com
研究場所
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Umeå、スウェーデン、90137
- まだ募集していません
- Europainclinics Sweden
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コンタクト：
- Robert Rapčan, MD, FIPP
- 電話番号：+421948006267
- メール：rapcan@europainclinics.com
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Košice、スロバキア、04001
- まだ募集していません
- Poliklinika Terasa
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コンタクト：
- Robert Rapčan, MD, FIPP
- 電話番号：+421948006267
- メール：rapcan@europainclinics.com
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Prague、チェコ、17000
- 募集
- EuroPainClinics Praha a.s
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コンタクト：
- Michal Matias, MD, FIPP
- 電話番号：+420602246127
- メール：matias@europainclinics.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Axial low back pain (with or without lateral component).
- Presence of Modic type I or II changes at ≥ 1 level.
- Age over 18 years.
- Duration of pain ≥ 6 months.
- Completion of full conservative management for ≥ 3 months.
- Medial Branch Block (MBB) test performed with negative results/ or Facet Denervation done with unsatisfactory outcome (less than 50% improvement) after positive MBB test.
Exclusion Criteria:
- Coagulation disorders.
- Platelet abnormalities.
- Lack of informed consent.
- Generalized solid tumor.
- Hematopoietic malignancy.
- Radicular pain.
- Alternative primary pain generators other than axial low back pain.
- Previous spinal surgery.
- Targeted level located above L3/L4
- Osteoporosis
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
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：BVN ablation
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intraosseal monopolar basivertebral nerve ablation
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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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The Oswestry Disability Index (ODI)
時間枠：6 weeks, and 3, 6, 12 months
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Scale 0-100%; a lower score indicates minimal disability, while a higher score indicates greater disability.
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6 weeks, and 3, 6, 12 months
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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 |
|---|---|---|
|
Numeric Rating Scale (NRS) for Pain
時間枠：6 weeks, and 3,6,12 months
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Scale 0-10; 0 refers to no pain, while 10 refers to worst imaginable pain
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6 weeks, and 3,6,12 months
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EQ-5D standardized questionnaire used to measure health-related quality of life
時間枠：6 weeks, and 3, 6 12 months
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Scale 0 - 100; where 0 (state equivalent to death) and 100 (full health)
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6 weeks, and 3, 6 12 months
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Pain, Enjoyment of Life, and General Activity (PEG) Assessment
時間枠：6 weeks, and 3, 6 12 months
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Scale 0 - 10; where 0 (no pain and no limitations) and 10 (worst imaginable pain, no life enjoyment and total limitation in general activities)
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6 weeks, and 3, 6 12 months
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Global Rating of Change (GRC)
時間枠：6 weeks, and 3, 6 12 months
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retrospective assessesment of condition change compared to the initial state; scale -5 to 5; where -5 (significant worsening), 0 (state unchanged), 5 (significant improvement).
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6 weeks, and 3, 6 12 months
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
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
その他の研究ID番号
- KS_EPCcz_2026/001
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?
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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