Erector Spinae Plane Block for Acute Back Pain in the Emergency Department
ConditionLow Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRush University Medical Center
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.
Disqualifiers
Do not speak English or Spanish as a primary language
Are incarcerated
Have a known pregnancy
Are allergic to amide-type local anesthetics
Trial design
Design model
Parallel
Treatments tested in this trial
Erector Spinae Plane Block
Procedure/SurgeryErector Spinae Plane Block
Sham Procedure
Procedure/SurgerySham Procedure
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: Erector Spinae Plane BlockExperimental treatment 1 intervention
Group B: Sham ProcedureSham comparator 1 intervention
Trial outcomes
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
Time frame
Change from baseline to 120 minutes post-interventionSecondary outcomes
1
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
Time frame
Change from baseline to 30 minutes post-intervention2
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
Time frame
Change from baseline to 60 minutes post-intervention3
Degree of disability assessed via the Roland-Morris disability questionnaire at 7 days
Participants will be scored using the validated Roland-Morris disability questionnaire.
Time frame
Assessed as the change in Roland-Morris disability questionnaire scores between baseline and 7 day follow up4
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
Time frame
Pain score assessed at 7 days post-interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov