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Sciatica AcuteNCT07588126

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

A study testing Ultrasound guided transgluteal sciatic nerve hydrodissection in people with Sciatica Acute and Sciatica Pain, run by Kaiser Permanente at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sciatica Acute, Sciatica Pain
What is being tested?
Ultrasound guided transgluteal sciatic nerve hydrodissection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
69 participants
Where
1 siteUnited States
Study dates
12 Jan 2024to 21 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kaiser Permanente

    San Diego, California, 92123

Other trials in United States

About this study

Official title: 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.

Being tested
Ultrasound guided transgluteal sciatic nerve hydrodissection
Keywords
Hydrodissection, Ultrasound guided, transgluteal sciatic nerve, sciatica, nerve block
Medical subject headings
Sciatica

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ultrasound guided transgluteal sciatic nerve hydrodissectionProcedure or surgery

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

Study groups in NCT07588126
Study groupRoleWhat they receive
Comparison groupNo interventionThese 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 hydrodissectionOtherThese patients received the transgluteal sciatic nerve hydrodissection injection procedure when a study investigator was present to administer it.
Receives: Procedure: Ultrasound guided transgluteal sciatic nerve hydrodissection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment to 72-hour follow-up completion

  2. 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.

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

Secondary outcomes (1)
  1. Change in Numeric Rating Scale (NRS) Pain Score From Baseline to Post-Treatment and 72-Hour 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2026
  2. Study start12 Jan 2024
  3. Primary completion21 Feb 2025
  4. Study completion21 Feb 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07588126
Sponsor's protocol ID
13784
Other IDs
13784
Status last verified
Jan 2024
First submitted
4 May 2026
Last updated
14 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 36933988
  • 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.

    PubMed 28778254
  • 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.

    PubMed 30187524
  • 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.

    PubMed 40766979
  • 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.

    PubMed 32801851
  • 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.

    PubMed 34261895
  • 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.

    PubMed 35760739
  • Goldsmith AJ, Merz-Herrala J, Gullikson J, Selame LA, Cash RE, Martin D, Driver L, 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.

    PubMed 40256350
  • 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.

    PubMed 26931789
  • 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.

    PubMed 38244244
  • 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/

    PubMed 33090751
  • 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.

    PubMed 22331277
  • 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.

    PubMed 21525139
  • 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.

    PubMed 27743405
  • 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.

    PubMed 28328324

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound guided transgluteal sciatic nerve hydrodissection in people with Sciatica Acute and Sciatica Pain, run by Kaiser Permanente at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07588126, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.

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