Neurolyser XR for the Treatment of Sacroiliitis
2026年6月12日 更新者:Pasquale Buonanno、Federico II University
Safety and Efficacy of Using the Neurolyser XR Device for the Treatment of Sacroiliac Joint Related Low Back Pain
Our study aims to investigate the safety and efficacy of high intensity focused ultrasound in the management of low back pain due to sacroiliitis.
Sacroiliitis is the inflammation of a joint in the lowest part of the spin and it is one of the cause of low back; the diagnosis is essentially based on clinical examination and the confirmation of this diagnosis relies on a significant pain relief following an infiltration of local anesthetic in the joint.
One of the potential treatment is to ablate the nerves which carry the painful stimuli from the joint to the central nervous system through; these nerves enter the spinal canal through the sacral foramina which are two series of four pairs of openings located on the sacrum, the triangular bone at the base of the spine.
Traditionally, these nerves are ablated by the heat produced by radiofrequency or the cold produced by cryoablation; both techniques require percutaneous needle insertion in close proximity to the targeted nerves, posing potential discomfort and risk of infection for the patient.
High intensity focused ultrasound delivered by the device Neurolyser XR uses ultrasounds which are converged to the targeted point thanks to a gel pad positioned on the back of the patient; this mechanism of action does not require sterile conditions as the skin is not pierced and the discomfort of patient is dramatically reduced during the procedure for there is non need to insert and move any needle to properly position it.
The correct orientation of the ultrasound beam is guaranteed by the alignment of the targeting system of the device and the X-ray image.
The lesion is produced only if there is a bone right under the focus of the ultrasound beam and this is a safety system which assures that no direct injuries of other structures (e.g., vessels, spinal root) can be caused.
To date, Neurolyser XR has been extensively used to treat facet joint syndrome through the ablation of the medial branches.
However, its application in sacroiliitis has not yet been as deeply investigated.
調査の概要
研究の種類
介入
入学 (推定)
30
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前:Pasquale Buonanno, Professor
- 電話番号:+39 081 7463705
- メール:pasquale.buonanno@unina.it
研究場所
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Naples、イタリア、80131
- Department of Neuroscience, Reproductive and Odontostomatological Sciences
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コンタクト:
- Pasquale Buonanno, Professor
- 電話番号:+390817463705
- メール:pasquale.buonanno@unina.it
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Adult males and females, legally able and willing to participate in the study and come for follow-up visits
- Able and willing to fill the research questionnaires and to communicate with investigator and research team
- Patient with bilateral or unilateral sacroiliac joint pain of > 6 months duration
- Patients presenting with a) a positive (>70% pain relief) to a previous nerve ablation procedure of the sacroiliac joint and / or b) with a positive (>70% pain relief) to a previous nerve block procedure of the sacroiliac joint within the last six months)
- Average pain score of 4 or higher in the last month, (on 0-10 scale).
Exclusion Criteria:
- Pregnant or breastfeeding patient
- Patients presenting with neurological deficits (including lumbosacral radiculopathy but not solitary radicular pain).
- Patients with history of lumbar and / or sacral spine surgery
- Patients with the presence of metal hardware at the lumbosacral spine
- Patients with history of pelvic pathology that may increase procedural risk and / or influence symptoms and / or generate unrelated adverse event (per the discretion of the study principal investigator)
- Patients unable to understand and complete the research questionnaires in Italian.
- Patients presenting with any severe medical condition preventing the patient from safely and effectively being treated in the study or reporting study outcome.
- Patient with extensive scarring in the skin and tissue overlying the treatment area.
- Patients enrolled in or planned to be enrolled in another clinical trial during the duration of this research project.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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:HIFU patients
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Patients in this group will be treated with high intensity focused ultrasound; they will be placed in a prone position and through radiographic guidance, the targeting system of the device will be sequentially positioned in 6-8 points along a line between sacral foramina and sacroiliac joint to produce as many lesions.
Before any ablation, a 20 second stimulation at low energy will be performed to confirm the right position of the ultrasound focus than a higher intensity stimulation will be applied to perform the 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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Pain intensity
時間枠:From the enrollment to the end of 6 month follow-up
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Numeric rating scale (NRS): the patient has to assign a number from 0 (no pain) to 10 (worst possible pain) to his pain
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From the enrollment to the end of 6 month follow-up
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Gofeld M, Smith KJ, Bhatia A, Djuric V, Leblang S, Rebhun N, Aginsky R, Miller E, Skoglind B, Hananel A. Fluoroscopy-guided high-intensity focused ultrasound neurotomy of the lumbar zygapophyseal joints: a prospective, open-label study. Reg Anesth Pain Med. 2025 Jun 10;50(6):464-470. doi: 10.1136/rapm-2024-105345.
- Gofeld M, Tiennot T, Miller E, Rebhun N, Mobley S, Leblang S, Aginsky R, Hananel A, Aubry JF. Fluoroscopy-guided high-intensity focused ultrasound ablation of the lumbar medial branch nerves: dose escalation study and comparison with radiofrequency ablation in a porcine model. Reg Anesth Pain Med. 2025 May 6;50(5):429-436. doi: 10.1136/rapm-2024-105417.
- Aginsky R, LeBlang S, Hananel A, Chen J, Gofeld M, Perez J, Shir Y, Aubry JF. Tolerability and Feasibility of X-ray Guided Non-Invasive Ablation of the Medial Branch Nerve with Focused Ultrasound: Preliminary Proof of Concept in a Pre-clinical Model. Ultrasound Med Biol. 2021 Mar;47(3):640-650. doi: 10.1016/j.ultrasmedbio.2020.10.019. Epub 2020 Nov 28.
- Mahapatra S, Francois H, Weber-Levine C, Jiang K, Bhimreddy M, Boateng A, Davidar AD, Routkevitch D, Chhatre A, Manbachi A, Theodore N. Focused ultrasound for the treatment of facet joint pain: a systematic review. Neurosurg Focus. 2024 Sep 1;57(3):E9. doi: 10.3171/2024.6.FOCUS24249.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年7月1日
一次修了 (推定)
2027年7月1日
研究の完了 (推定)
2027年7月1日
試験登録日
最初に提出
2026年6月10日
QC基準を満たした最初の提出物
2026年6月10日
最初の投稿 (実際)
2026年6月15日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月16日
QC基準を満たした最後の更新が送信されました
2026年6月12日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。