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

May 8, 2026 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Kaiser Permanente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Other: transgluteal sciatic nerve hydrodissection
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
Injection of dextrose in water solution (D5W) under ultrasound guidance into the tissue plane that encloses the sciatic nerve between its two neighboring muscles.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Successful Transgluteal Sciatic Nerve Hydrodissection (TSNH) Procedure Completion Among Eligible Emergency Department Patients
Time Frame: From enrollment to 72-hour follow-up completion
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)
Time Frame: From time of injection to 72-hour post-discharge telephone follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Post-Treatment and 72-Hour Follow-Up
Time Frame: From enrollment to 72-hour post-discharge follow-up
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.
From enrollment to 72-hour post-discharge follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Investigators

  • Principal Investigator: Gabriel Rose, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2024

Primary Completion (Actual)

February 21, 2025

Study Completion (Actual)

February 21, 2025

Study Registration Dates

First Submitted

May 4, 2026

First Submitted That Met QC Criteria

May 8, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13784 (Other Identifier: Kaiser Permanente Southern California IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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 Sharing Time Frame

Data will be available beginning 6 months following publication of the primary results and will remain available for 3 years thereafter.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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