Low Back PainNCT06745453
Erector Spinae Plane Block for Acute Back Pain in the Emergency Department
A study testing Erector Spinae Plane Block in people with Low Back Pain, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Aylin Ornelas Loredo, MMS, 312-563-0645, aylin_a_ornelasloredo@rush.edu
Michelle Santangelo, MS, 312-563-0645, michelle_santangelo@rush.edu
About this study
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:
- Does the ESPB reduce short-term pain in participants with low back pain?
- Does the ESPB reduce longer-term pain, reduce disability, and improve return to work and activities in participants with low back pain?
Read more
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
- Conditions
- Low Back Pain
- Being tested
- Erector Spinae Plane Block, Sham Procedure
- Keywords
- erector spinae plane block, emergency department, low back pain, regional anesthesia, nerve block
- Medical subject headings
- Low Back Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Erector Spinae Plane Block
Sham ProcedureProcedure or surgery
Sham Procedure
| Study group | Role | What they receive |
|---|---|---|
| Erector Spinae Plane Block | Experimental | This group will receive the erector spinae plane block Receives: Procedure: Erector Spinae Plane Block |
| Sham Procedure | Sham comparator | This group will receive a sham injection. Receives: Procedure: Sham Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Zero is equivalent to no pain and 10 indicates worst pain imaginable
Measured: Change from baseline to 30 minutes post-intervention
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
Measured: Change from baseline to 60 minutes post-intervention
Degree of disability assessed via the Roland-Morris disability questionnaire at 7 days
Participants will be scored using the validated Roland-Morris disability questionnaire.
Measured: 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
Zero is equivalent to no pain and 10 indicates worst pain imaginable
Measured: Pain score assessed at 7 days post-intervention
Opioid medications taken in the 7 days following the intervention
Calculated in morphine milligram equivalents
Measured: Measured at 7 days post-intervention
Follow up visits related to low back pain in the 7 days following the intervention
Based upon patient self-report
Measured: Assessed at 7 days
Return to work and activities assessed via the Work Productivity and Activity Impairment Questionnaire: General Health version 2.0
Assessed using the validated Work Productivity and Activity Impairment Questionnaire: General Health version 2.0 questionnaire
Measured: Assessed at 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start3 Feb 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Gottlieb, Rush University Medical Center
- Investigators
- Michael Gottlieb, MD, Principal investigator, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745453
- Sponsor's protocol ID
- 24062802
- Status last verified
- Mar 2026
- First submitted
- 17 Dec 2024
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Acute Back Pain in the Emergency Department
- ClinicalTrials.gov ID
- NCT06745453
- Acronym / sponsor ID
- 24062802
- Conditions
- Low Back Pain
- Keywords
- erector spinae plane block, emergency department, low back pain, regional anesthesia, nerve block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Does the ESPB reduce short-term pain in participants with low back pain?
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erector Spinae Plane Block | Experimental | Procedure: Erector Spinae Plane BlockThis group will receive the erector spinae plane block |
| Sham Procedure | Sham comparator | Procedure: Sham ProcedureThis group will receive a sham injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults (age ≥18 years) presenting to the emergency department with isolated low back pain present less than 6 total weeks.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockErector Spinae Plane Block | Procedure or surgery | Erector Spinae Plane Block |
| Sham ProcedureSham Procedure | Procedure or surgery | Sham Procedure |
Primary outcome
Pain score at 120 minutes post-intervention as assessed using a 10-point numeric rating scale
Time frame: Change from baseline to 120 minutes post-intervention
Zero is equivalent to no pain and 10 indicates worst pain imaginable
7 secondary outcomes
Pain score at 30 minutes post-intervention as assessed using a 10-point numeric rating scale
Time frame: Change from baseline to 30 minutes post-intervention
Pain score at 60 minutes post-intervention as assessed using a 10-point numeric rating scale
Time frame: Change from baseline to 60 minutes post-intervention
Degree of disability assessed via the Roland-Morris disability questionnaire at 7 days
Time frame: 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
Time frame: Pain score assessed at 7 days post-intervention
Opioid medications taken in the 7 days following the intervention
Time frame: Measured at 7 days post-intervention
Follow up visits related to low back pain in the 7 days following the intervention
Time frame: Assessed at 7 days
Return to work and activities assessed via the Work Productivity and Activity Impairment Questionnaire: General Health version 2.0
Time frame: Assessed at 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Gottlieb, MD principal investigator
Rush University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block in people with Low Back Pain, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aylin Ornelas Loredo, MMS (312-563-0645, aylin_a_ornelasloredo@rush.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score at 120 minutes post-intervention as assessed using a 10-point numeric rating scale (time frame: Change from baseline to 120 minutes post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.