Rush University Medical Center
Chicago, Illinois, 60612, United States
Location status: Recruiting
Location contact
Aylin Ornelas Loredo, MMS
CONTACT
Michael Gottlieb, MD
PRINCIPAL_INVESTIGATOR
Michelle Santangelo, MS
CONTACT
NCT Number: NCT06745453
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
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Chicago, Illinois, 60612, United States
Location status: Recruiting
Aylin Ornelas Loredo, MMS
CONTACT
Michael Gottlieb, MD
PRINCIPAL_INVESTIGATOR
Michelle Santangelo, MS
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Erector Spinae Plane Block
Sham Procedure
Time frame: Change from baseline to 120 minutes post-intervention
Zero is equivalent to no pain and 10 indicates worst pain imaginable
Time frame: Change from baseline to 30 minutes post-intervention
Zero is equivalent to no pain and 10 indicates worst pain imaginable
Time frame: Change from baseline to 60 minutes post-intervention
Zero is equivalent to no pain and 10 indicates worst pain imaginable
Time frame: 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.
Time frame: Pain score assessed at 7 days post-intervention
Zero is equivalent to no pain and 10 indicates worst pain imaginable
Time frame: Measured at 7 days post-intervention
Calculated in morphine milligram equivalents
Time frame: Assessed at 7 days
Based upon patient self-report
Time frame: Assessed at 7 days
Assessed using the validated Work Productivity and Activity Impairment Questionnaire: General Health version 2.0 questionnaire
Contact information is provided by the study sponsor or research team.
Aylin Ornelas Loredo, MMS
CONTACT
Michelle Santangelo, MS
CONTACT
Rush University Medical Center
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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