Ultrasound-guided Transgluteal Sciatic Nerve Hydrodissection for the Treatment of Sciatica in the Emergency Department
2026年5月8日 更新者：Kaiser Permanente
Ultrasound Guided Transgluteal Sciatic Nerve Hydrodissection for the Treatment of Sciatica in the Emergency Department
The goal of this observational study is to see whether it would be feasible to treat patients who come to the emergency department with pain related to sciatica using an ultrasound guided injection of dextrose in water solution ("sugar water") into the tissue that surrounds the sciatic nerve in the gluteal region. THe study will looks at a few things:
- Is the treatment feasible within the setting of the emergency department
- Is the treatment safe in the short term (up to 72 hours after the injection)
- Is the treatment good for lowering patients' pain from sciatica in the short term (immediate and up to 72 hours' follow up)
- How does the treatment compare to current standard medicines given to patients for sciatica in the emergency department in terms of lowering pain
Patients who came to the emergency department and had the injection as part of their care for sciatica will answer some questions about their symptoms during a phone call follow up 72 hours after leaving the emergency department.
調査の概要
研究の種類
介入
入学 (実際)
69
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。
研究場所
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California
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San Diego、California、アメリカ、92123
- Kaiser Permanente
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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:
- Age 18 years or older
- Clinically diagnosed acute sciatica, defined as pain and/or paresthesias in a -sciatic nerve distribution
- Willing to undergo the injection procedure
- Verbal informed consent provided prior to enrollment
- Adequate sonographic visualization of the sciatic nerve in the transgluteal window confirmed on screening ultrasound
Exclusion Criteria:
- Fever or signs of systemic infection
- Suspected spinal infection
- Suspected spinal malignancy
- Signs or symptoms of cauda equina syndrome
- Acute traumatic mechanism of pain
- Localized infection or skin breakdown at the proposed injection site
- Known allergy to study injectate (5% dextrose in water) or procedural materials
- Refusal to participate
- Inability to adequately visualize the target anatomy on ultrasound for safe injection
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：非ランダム化
- 介入モデル：並列代入
- 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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介入なし：Comparison group
These are patients who received current usual or standard treatment for their sciatic pain, such as oral pills and/or intravenous or intramuscular injections with various medications in the emergency department.
These patients are followed contemporaneously as a comparison to the patients who received the hydrodissection injection.
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他の：transgluteal sciatic nerve hydrodissection
These patients received the transgluteal sciatic nerve hydrodissection injection procedure when a study investigator was present to administer it.
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Injection of dextrose in water solution (D5W) under ultrasound guidance into the tissue plane that encloses the sciatic nerve between its two neighboring muscles.
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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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Rate of Successful Transgluteal Sciatic Nerve Hydrodissection (TSNH) Procedure Completion Among Eligible Emergency Department Patients
時間枠：From enrollment to 72-hour follow-up completion
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Procedural feasibility will be assessed using four metrics: (1) Enrollment rate, measured as proportion of screened patients meeting eligibility criteria who were enrolled; (2) Procedural attempt rate, measured as proportion of enrolled patients in whom TSNH was attempted; (3) Procedural completion rate, measured as proportion of attempted procedures in which successful injection of D5W was achieved on ultrasound visualization; (4) Follow-up completion rate, measured as proportion of enrolled patients completing the 72-hour structured telephone follow-up.
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From enrollment to 72-hour follow-up completion
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Incidence of Procedure-Related Adverse Events Within 72 Hours Following Transgluteal Sciatic Nerve Hydrodissection (TSNH)
時間枠：From time of injection to 72-hour post-discharge telephone follow-up
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Incidence of adverse events assessed via structured 72-hour telephone follow-up using a standardized script administered to all patients participants by study the investigators.
Adverse events evaluated include: (1) new or worsening motor weakness in the ipsilateral lower extremity; (2) new sensory disturbance in the ipsilateral lower extremity; (3) injection-site pain beyond expected post-procedural soreness; (4) signs or symptoms of injection-site infection.
Results reported as number and percentage of participants experiencing each adverse event type.
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From time of injection to 72-hour post-discharge telephone follow-up
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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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Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Post-Treatment and 72-Hour Follow-Up
時間枠：From enrollment to 72-hour post-discharge follow-up
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Change in self-reported pain level measured using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 = no pain and 10 = worst possible pain (higher scores indicate worse outcome).
Scores recorded at three timepoints: (1) baseline, prior to any treatment in the ED; (2) post-treatment, approximately 15 minutes after TSNH procedure completion for the TSNH group, and at a comparable timepoint for the comparison group; (3) 72-hour follow-up, via structured telephone contact after ED discharge.
Change from baseline pain level calculated at each timepoint.
Pain scores compared between participants receiving TSNH and a contemporaneous comparison group receiving standard pharmacologic care.
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From enrollment to 72-hour post-discharge 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
捜査官
- 主任研究者：Gabriel Rose、Kaiser Permanente
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
- Lam KHS, Hung CY, Chiang YP, Onishi K, Su DCJ, Clark TB, Reeves KD. Ultrasound-Guided Nerve Hydrodissection for Pain Management: Rationale, Methods, Current Literature, and Theoretical Mechanisms. J Pain Res. 2020 Aug 4;13:1957-1968. doi: 10.2147/JPR.S247208. eCollection 2020.
- Koes BW, van Tulder MW, Peul WC. Diagnosis and treatment of sciatica. BMJ. 2007 Jun 23;334(7607):1313-7. doi: 10.1136/bmj.39223.428495.BE. No abstract available.
- Roncoroni C, Baillet A, Durand M, Gaudin P, Juvin R. Efficacy and tolerance of systemic steroids in sciatica: a systematic review and meta-analysis. Rheumatology (Oxford). 2011 Sep;50(9):1603-11. doi: 10.1093/rheumatology/ker151. Epub 2011 Apr 27.
- Amini R, Kartchner JZ, Nagdev A, Adhikari S. Ultrasound-Guided Nerve Blocks in Emergency Medicine Practice. J Ultrasound Med. 2016 Apr;35(4):731-6. doi: 10.7863/ultra.15.05095. Epub 2016 Mar 1.
- Mathieson S, Maher CG, McLachlan AJ, Latimer J, Koes BW, Hancock MJ, Harris I, Day RO, Billot L, Pik J, Jan S, Lin CC. Trial of Pregabalin for Acute and Chronic Sciatica. N Engl J Med. 2017 Mar 23;376(12):1111-1120. doi: 10.1056/NEJMoa1614292.
- Wu YT, Ke MJ, Ho TY, Li TY, Shen YP, Chen LC. Randomized double-blinded clinical trial of 5% dextrose versus triamcinolone injection for carpal tunnel syndrome patients. Ann Neurol. 2018 Oct;84(4):601-610. doi: 10.1002/ana.25332. Epub 2018 Oct 4.
- Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Tsai CK, Chen LC. Six-month Efficacy of Perineural Dextrose for Carpal Tunnel Syndrome: A Prospective, Randomized, Double-Blind, Controlled Trial. Mayo Clin Proc. 2017 Aug;92(8):1179-1189. doi: 10.1016/j.mayocp.2017.05.025.
- Neo EJR, Shan NT, Tay SS. Hydrodissection for Carpal Tunnel Syndrome: A Systematic Review. Am J Phys Med Rehabil. 2022 Jun 1;101(6):530-539. doi: 10.1097/PHM.0000000000001846. Epub 2021 Jul 14.
- Goldsmith AJ, Merz-Herrala J, Gullikson J, Selame LA, Cash RE, Martin D, Schwimmer H, Shokoohi H, Duggan NM, Nagdev A. The Efficacy of Ultrasound-Guided Transgluteal Sciatic Nerve Blocks for Sciatic Radiculopathy Pain in the Emergency Department: A Multicenter Prospective Study. J Am Coll Emerg Physicians Open. 2025 Apr 10;6(3):100137. doi: 10.1016/j.acepjo.2025.100137. eCollection 2025 Jun.
- Silver D, Esener D, Rose G. Ultrasound guided transgluteal sciatic nerve hydrodissection for the treatment of acute sciatica in the emergency department. Am J Emerg Med. 2023 Jul;69:219.e3-219.e6. doi: 10.1016/j.ajem.2023.02.026. Epub 2023 Feb 28.
- Colorado B, McNeill D, Norbury J. Ultrasound-Guided Nerve Hydrodissection for Peripheral Entrapment Neuropathies. Muscle Nerve. 2025 Nov;72(5):1052-1059. doi: 10.1002/mus.28471. Epub 2025 Aug 6.
- Macias R, Diaz D, Prats MI. Motor blockade from transgluteal sciatic nerve block in the emergency department. Am J Emerg Med. 2022 Oct;60:193-194. doi: 10.1016/j.ajem.2022.06.029. Epub 2022 Jun 21. No abstract available.
- Goldsmith AJ, Brown J, Duggan NM, Finkelberg T, Jowkar N, Stegeman J, Riscinti M, Nagdev A, Amini R. Ultrasound-guided nerve blocks in emergency medicine practice: 2022 updates. Am J Emerg Med. 2024 Apr;78:112-119. doi: 10.1016/j.ajem.2023.12.043. Epub 2024 Jan 12.
- National Guideline Centre (UK). Evidence review for pharmacological management of sciatica: Low back pain and sciatica in over 16s: assessment and management: Evidence review A. London: National Institute for Health and Care Excellence (NICE); 2020 Sep. Available from http://www.ncbi.nlm.nih.gov/books/NBK562934/
- Pinto RZ, Maher CG, Ferreira ML, Ferreira PH, Hancock M, Oliveira VC, McLachlan AJ, Koes B. Drugs for relief of pain in patients with sciatica: systematic review and meta-analysis. BMJ. 2012 Feb 13;344:e497. doi: 10.1136/bmj.e497.
- Rasmussen-Barr E, Held U, Grooten WJ, Roelofs PD, Koes BW, van Tulder MW, Wertli MM. Non-steroidal anti-inflammatory drugs for sciatica. Cochrane Database Syst Rev. 2016 Oct 15;10(10):CD012382. doi: 10.1002/14651858.CD012382.
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 (実際)
2024年1月12日
一次修了 (実際)
2025年2月21日
研究の完了 (実際)
2025年2月21日
試験登録日
最初に提出
2026年5月4日
QC基準を満たした最初の提出物
2026年5月8日
最初の投稿 (実際)
2026年5月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月14日
QC基準を満たした最後の更新が送信されました
2026年5月8日
最終確認日
2024年1月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 13784 (その他の識別子：Kaiser Permanente Southern California IRB)
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?
はい
IPD プランの説明
De-identified individual participant data (IPD) may be made available upon reasonable request, contingent upon institutional review and approval.
Shared data will include selected variables necessary to reproduce the primary analyses, along with a data dictionary.
Requests will require a methodologically sound proposal and execution of a data use agreement to ensure protection of participant confidentiality.
IPD 共有時間枠
Data will be available beginning 6 months following publication of the primary results and will remain available for 3 years thereafter.
IPD 共有アクセス基準
Access will be granted to qualified researchers with a methodologically sound proposal.
Available materials will include de-identified individual participant data, data dictionary, study protocol, and statistical analysis plan.
Requests will be reviewed by the study team and sponsoring institution, and access will require execution of a data use agreement.
Data will be provided in a secure, de-identified format via electronic transfer.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
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
いいえ
米国FDA規制機器製品の研究
いいえ
米国で製造され、米国から輸出された製品。
いいえ
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