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

Not Applicable

Recruiting

• Conditions: Low Back Pain

• Registration Number: NCT06745453
• Lead Sponsor: Rush University Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Study Start: 2025-02-03
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-10
• Primary Completion: 2026-06-23
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States