Ultrasound-guided Transgluteal Sciatic Nerve Hydrodissection for the Treatment of Sciatica in the Emergency Department
8 mei 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Werkelijk)
69
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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California
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San Diego, California, Verenigde Staten, 92123
- Kaiser Permanente
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Geen tussenkomst: 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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Ander: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Rate of Successful Transgluteal Sciatic Nerve Hydrodissection (TSNH) Procedure Completion Among Eligible Emergency Department Patients
Tijdsspanne: 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)
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Post-Treatment and 72-Hour Follow-Up
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Gabriel Rose, Kaiser Permanente
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
12 januari 2024
Primaire voltooiing (Werkelijk)
21 februari 2025
Studie voltooiing (Werkelijk)
21 februari 2025
Studieregistratiedata
Eerst ingediend
4 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
8 mei 2026
Eerst geplaatst (Werkelijk)
14 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
14 mei 2026
Laatste update ingediend die voldeed aan QC-criteria
8 mei 2026
Laatst geverifieerd
1 januari 2024
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13784 (Andere identificatie: Kaiser Permanente Southern California IRB)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
JA
Beschrijving IPD-plan
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-tijdsbestek voor delen
Data will be available beginning 6 months following publication of the primary results and will remain available for 3 years thereafter.
IPD-toegangscriteria voor delen
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 delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
product vervaardigd in en geëxporteerd uit de V.S.
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .