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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Erector Spinae Plane Block | Experimental | This group will receive the erector spinae plane block |
|
| Sham Procedure | Sham Comparator | This group will receive a sham injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane Block | Procedure | Erector Spinae Plane Block |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline to 30 minutes post-intervention |
| Pain score at 60 minutes post-intervention as assessed using a 10-point numeric rating scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aylin Ornelas Loredo, MMS | Contact | 312-563-0645 | aylin_a_ornelasloredo@rush.edu | |
| Michelle Santangelo, MS | Contact | 312-563-0645 | michelle_santangelo@rush.edu |
| Name | Affiliation | Role |
|---|---|---|
| Michael Gottlieb, MD | Rush University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Recruiting | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Sham Procedure |
| Procedure |
Sham Procedure |
|
Zero is equivalent to no pain and 10 indicates worst pain imaginable |
| 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. | 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 | Pain score assessed at 7 days post-intervention |
| Opioid medications taken in the 7 days following the intervention | Calculated in morphine milligram equivalents | 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 | 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 | Assessed at 7 days |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |