Low Back Pain
Conditions
Keywords
erector spinae plane block, emergency department, low back pain, regional anesthesia, nerve block
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
Interventions
PROCEDUREErector Spinae Plane Block
Erector Spinae Plane Block
PROCEDURESham Procedure
Sham Procedure
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Opioid medications taken in the 7 days following the intervention | Measured at 7 days post-intervention | Calculated in morphine milligram equivalents |
| Follow up visits related to low back pain in the 7 days following the intervention | Assessed at 7 days | Based upon patient self-report |
| 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 |
Countries
United States
Contacts
CONTACTAylin Ornelas Loredo, MMS
CONTACTMichelle Santangelo, MS
PRINCIPAL_INVESTIGATORMichael Gottlieb, MD
Rush University Medical Center
Outcome results
None listed