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Delay for subject recruitment and then not feasible with COVID>
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This study will evaluate the addition of lidocaine % transdermal patches to standard therapy in the treatment of acute non-radicular low back pain in patients discharged from the Emergency Department. In addition to standard therapy, half of the participants will receive medicated patches while the other half will receive non-medicated patches.
Low back pain is a common emergency department (ED) chief complaint. Multiple therapies have been evaluated in the treatment of ED patients with low back pain including acetaminophen, NSAIDS, opioids, steroids, and muscle relaxants.
Lidocaine is a local anesthetic that can be administered by various routes. It is used in a transdermal patch for the treatment of pain. It is commonly used for focal causes of pain, including low back pain. The addition of lidocaine 5% patches to standard low back pain therapy has not been rigorously evaluated, although it is frequently used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine 5% patch | Experimental | Patients will receive a 7 day supply (21 patches) of lidocaine 5% patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician. |
|
| Non-medicated patch | Active Comparator | Patients will receive a 7 day supply (21 patches) of non-medicated patches upon discharge from the emergency department in addition to "standard therapy" at the discretion of the treating emergency department physician. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine 5% patch | Drug | transdermal patch |
| |
| standard therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Pain Rating Scale (NRS) | Patient description of pain on a scale of 0-10 | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Roland-Morris-24 back pain disability scale | 24 point back pain disability scale | 1 week and 1 month |
| Numerical Pain Rating Scale (NRS) | Patient description of pain on a scale of 0-10 |
| Measure | Description | Time Frame |
|---|---|---|
| Repeat visits | Repeat visits to an emergency department | 1 week and 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| John H Stroger Jr Hospital of Cook County | Chicago | Illinois | 60612 | United States |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D057968 | Transdermal Patch |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Drug |
Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc) |
|
| Non-medicated patch | Drug | non-medicated patch |
|
| 1 month |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D004864 | Equipment and Supplies |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |