Ultrasound-guided Transgluteal Sciatic Nerve Hydrodissection for the Treatment of Sciatica in the Emergency Department

NCT07588126 | Completed

• 1 other identifier: 13784
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sciatica Acute; Sciatica Pain

Keywords

Hydrodissection; Ultrasound guided; transgluteal sciatic nerve; sciatica; nerve block

Outcome Measures

Primary Outcomes (2)

• Rate of Successful Transgluteal Sciatic Nerve Hydrodissection (TSNH) Procedure Completion Among Eligible Emergency Department Patients

  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.

  From enrollment to 72-hour follow-up completion

• Incidence of Procedure-Related Adverse Events Within 72 Hours Following Transgluteal Sciatic Nerve Hydrodissection (TSNH)

  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.

  From time of injection to 72-hour post-discharge telephone follow-up

Secondary Outcomes (1)

• Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Post-Treatment and 72-Hour Follow-Up

  From enrollment to 72-hour post-discharge follow-up

Study Arms (2)

Comparison group

NO INTERVENTION

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.

transgluteal sciatic nerve hydrodissection

OTHER

These patients received the transgluteal sciatic nerve hydrodissection injection procedure when a study investigator was present to administer it.

Procedure: Ultrasound guided transgluteal sciatic nerve hydrodissection

Interventions

Ultrasound guided transgluteal sciatic nerve hydrodissection PROCEDURE

Injection of dextrose in water solution (D5W) under ultrasound guidance into the tissue plane that encloses the sciatic nerve between its two neighboring muscles.

transgluteal sciatic nerve hydrodissection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead

Study Sites (1)

Kaiser Permanente

San Diego, California, 92123, United States

Location

Related Publications (16)

• 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.

  PMID: 36933988 BACKGROUND

• 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.

  PMID: 28778254 BACKGROUND

• 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.

  PMID: 30187524 BACKGROUND

• 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.

  PMID: 40766979 BACKGROUND

• 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.

  PMID: 32801851 BACKGROUND

• 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.

  PMID: 34261895 BACKGROUND

• 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.

  PMID: 35760739 BACKGROUND

• 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.

  PMID: 40256350 BACKGROUND

• 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.

  PMID: 26931789 BACKGROUND

• 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.

  PMID: 38244244 BACKGROUND

• 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/

  PMID: 33090751 BACKGROUND

• 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.

  PMID: 22331277 BACKGROUND

• 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.

  PMID: 21525139 BACKGROUND

• 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.

  PMID: 27743405 BACKGROUND

• 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.

  PMID: 28328324 BACKGROUND

• 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.

  PMID: 17585160 BACKGROUND

MeSH Terms

Conditions

Sciatica

Condition Hierarchy (Ancestors)

Sciatic Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gabriel Rose

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with sciatica who come to the emergency department while one of the study investigators is present may receive the injection, while those who came when no investigator was present received usual standard care and were followed as a comparison group.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 14, 2026
• Study Start: January 12, 2024
• Primary Completion: February 21, 2025
• Study Completion: February 21, 2025
• Last Updated: May 14, 2026

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months following publication of the primary results and will remain available for 3 years thereafter.
• Access Criteria: 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.

Locations

US (1)