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

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

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Procedure: Erector Spinae Plane Block; Procedure: Sham Procedure

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aylin Ornelas Loredo, MMS; Phone Number: 312-563-0645; Email: aylin_a_ornelasloredo@rush.edu
• Study Contact Backup: Name: Michelle Santangelo, MS; Phone Number: 312-563-0645; Email: michelle_santangelo@rush.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Recruiting
      • Rush University Medical Center
      • Principal Investigator: Michael Gottlieb, MD
      • Contact: Aylin Ornelas Loredo, MMS; Phone Number: 312-563-0645; Email: aylin_a_ornelasloredo@rush.edu
      • Contact: Michelle Santangelo, MS; Phone Number: 312-563-0645; Email: michelle_santangelo@rush.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Erector Spinae Plane Block; This group will receive the erector spinae plane block	Procedure: Erector Spinae Plane Block; Erector Spinae Plane Block
Sham Comparator: Sham Procedure; This group will receive a sham injection.	Procedure: Sham Procedure; Sham Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score at 120 minutes post-intervention as assessed using a 10-point numeric rating scale	Zero is equivalent to no pain and 10 indicates worst pain imaginable	Change from baseline to 120 minutes post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score at 30 minutes post-intervention as assessed using a 10-point numeric rating scale	Zero is equivalent to no pain and 10 indicates worst pain imaginable	Change from baseline to 30 minutes post-intervention
Pain score at 60 minutes post-intervention as assessed using a 10-point numeric rating scale	Zero is equivalent to no pain and 10 indicates worst pain imaginable	Change from baseline to 60 minutes post-intervention
Degree of disability assessed via the Roland-Morris disability questionnaire at 7 days	Participants will be scored using the validated Roland-Morris disability questionnaire.	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	Zero is equivalent to no pain and 10 indicates worst pain imaginable	Pain score assessed at 7 days post-intervention
Opioid medications taken in the 7 days following the intervention	Calculated in morphine milligram equivalents	Measured at 7 days post-intervention
Follow up visits related to low back pain in the 7 days following the intervention	Based upon patient self-report	Assessed at 7 days
Return to work and activities assessed via the Work Productivity and Activity Impairment Questionnaire: General Health version 2.0	Assessed using the validated Work Productivity and Activity Impairment Questionnaire: General Health version 2.0 questionnaire	Assessed at 7 days

Collaborators and Investigators

• Sponsor: Rush University Medical Center
• Investigators: Principal Investigator: Michael Gottlieb, MD, Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: low back pain; nerve block; emergency department; regional anesthesia; erector spinae plane block
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Disease Attributes; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Emergencies; Low Back Pain
• Other Study ID Numbers: 24062802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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