An interventional study of Ultrasound guided transgluteal sciatic nerve hydrodissection in Sciatica Acute and Sciatica Pain, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Kaiser Permanente · Not applicable, Interventional, and Treatment
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:
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.
149 studies on the registry are indexed under Sciatica; 31 are open to participants now.
This study's enrollment of 69 is close to the median of 68 across 122 interventional studies indexed under Sciatica.
Browse Sciatica studies →Kaiser Permanente is the lead sponsor of 393 studies on the registry; 43 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
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.
Time frame: 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.
Time frame: From time of injection to 72-hour post-discharge telephone follow-up
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.
Time frame: From enrollment to 72-hour post-discharge follow-up
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
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.
This study is completed, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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