Sciatica Acute, Sciatica Pain
Conditions
Keywords
Hydrodissection, Ultrasound guided, transgluteal sciatic nerve, sciatica, nerve block
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.
Interventions
PROCEDUREUltrasound 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.
Sponsors
Kaiser Permanente
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Successful Transgluteal Sciatic Nerve Hydrodissection (TSNH) Procedure Completion Among Eligible Emergency Department Patients | 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. |
| Incidence of Procedure-Related Adverse Events Within 72 Hours Following Transgluteal Sciatic Nerve Hydrodissection (TSNH) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGabriel Rose
Kaiser Permanente
Outcome results
None listed