NCT06745453

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. 1.Does the ESPB reduce short-term pain in participants with low back pain?
  2. 2.Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
7mo left

Started Feb 2025

Typical duration for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Feb 2025Dec 2026

First Submitted

Initial submission to the registry

December 17, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

1.9 years

First QC Date

December 17, 2024

Last Update Submit

March 11, 2026

Conditions

Low Back Pain

Keywords

erector spinae plane blockemergency departmentlow back painregional anesthesianerve block

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Pain score at 30 minutes post-intervention as assessed using a 10-point numeric rating scale

    Change from baseline to 30 minutes post-intervention

  • Pain score at 60 minutes post-intervention as assessed using a 10-point numeric rating scale

    Change from baseline to 60 minutes post-intervention

  • 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

  • Pain score at 7 days post-intervention as assessed using a 10-point numeric rating scale

    Pain score assessed at 7 days post-intervention

  • Opioid medications taken in the 7 days following the intervention

    Measured at 7 days post-intervention

  • +2 more secondary outcomes

Study Arms (2)

Erector Spinae Plane Block

EXPERIMENTAL

This group will receive the erector spinae plane block

Procedure: Erector Spinae Plane Block

Sham Procedure

SHAM COMPARATOR

This group will receive a sham injection.

Procedure: Sham Procedure

Interventions

Erector Spinae Plane BlockPROCEDURE

Erector Spinae Plane Block

Erector Spinae Plane Block
Sham ProcedurePROCEDURE

Sham Procedure

Sham Procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Low Back PainEmergencies

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Michael Gottlieb, MD

    Rush University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aylin Ornelas Loredo, MMS

CONTACT

312-563-0645aylin_a_ornelasloredo@rush.edu

Michelle Santangelo, MS

CONTACT

312-563-0645michelle_santangelo@rush.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Emergency Medicine

Study Record Dates

First Submitted

December 17, 2024

First Posted

December 20, 2024

Study Start

February 3, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

March 12, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)