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Recruiting NCT06745453

Erector Spinae Plane Block for Acute Back Pain in the Emergency Department

No phase Interventional Low Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erector Spinae Plane Block, Sham Procedure.
Who it may be relevant to
Registry conditions: Low Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The goal of this clinical trial is to learn if an erector spinae plane block (ESPB; a type of nerve block) works to reduce pain in adults presenting to the emergency department with low back pain. It will also learn if the ESPB reduces pain, disability, and return to work at 7 days. The main questions it aims to answer are: 1. Does the ESPB reduce short-term pain in participants with low back pain? 2. Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain? Researchers will compare ESPB to a placebo (an injection that does not involve a nerve block) to see if ESPB works to treat low back pain. Participants will: Receive either the ESPB or a placebo injection in the emergency department Report their pain scores for up to 120 minutes Report their pain, disability, and return to work at 7 days

Interventions

  • Procedure Erector Spinae Plane Block
    Erector Spinae Plane Block
  • Procedure Sham Procedure
    Sham Procedure

Primary outcome measures

  • Pain score at 120 minutes post-intervention as assessed using a 10-point numeric rating scale [Time frame: Change from baseline to 120 minutes post-intervention]
Secondary outcome measures (7)
  • Pain score at 30 minutes post-intervention as assessed using a 10-point numeric rating scale [Time frame: Change from baseline to 30 minutes post-intervention]
  • Pain score at 60 minutes post-intervention as assessed using a 10-point numeric rating scale [Time frame: Change from baseline to 60 minutes post-intervention]
  • Degree of disability assessed via the Roland-Morris disability questionnaire at 7 days [Time frame: Assessed as the change in Roland-Morris disability questionnaire scores between baseline and 7 day follow up]
  • Pain score at 7 days post-intervention as assessed using a 10-point numeric rating scale [Time frame: Pain score assessed at 7 days post-intervention]
  • Opioid medications taken in the 7 days following the intervention [Time frame: Measured at 7 days post-intervention]
  • Follow up visits related to low back pain in the 7 days following the intervention [Time frame: Assessed at 7 days]
  • Return to work and activities assessed via the Work Productivity and Activity Impairment Questionnaire: General Health version 2.0 [Time frame: Assessed at 7 days]

Eligibility criteria

Inclusion criteria

  • Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.

Exclusion criteria

  • Do not speak English or Spanish as a primary language
  • Are incarcerated
  • Have a known pregnancy
  • Are allergic to amide-type local anesthetics
  • Are unable to tolerate positioning for the procedure
  • Have a critical illness precluding the ability to perform the procedure.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Rush University Medical Center — Chicago

Identifiers

NCT: NCT06745453 · 24062802

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗