Low Back Pain
Conditions
Keywords
lidocaine
Brief summary
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.
Detailed description
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.
Interventions
transdermal patch
DRUGstandard therapy
Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)
DRUGNon-medicated patch
non-medicated patch
Sponsors
Cook County Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
24 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* pain originating between the lower border of the scapulae and the upper gluteal folds * treating ED physician plan for discharge of the patient
Exclusion criteria
* radicular pain defined as pain radiating below the gluteal folds * direct trauma to the back within previous month * pain of greater than 2 weeks duration or greater than 1 LBP episode per month in the past 3 months * patient being pregnant or lactating; no access to phone or ability to participate in follow-up phone calls * known allergy to lidocaine or skin breakdown over site of pain * treating physician plan for opioid prescription (tramadol, codeine, hydrocodone) * personal history of malignancy, fever (temperature greater than 37.9ºC), or previous spinal surgery * patients who are detainees * previous enrollment in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numerical Pain Rating Scale (NRS) | 1 week | Patient description of pain on a scale of 0-10 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Roland-Morris-24 back pain disability scale | 1 week and 1 month | 24 point back pain disability scale |
| Numerical Pain Rating Scale (NRS) | 1 month | Patient description of pain on a scale of 0-10 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Repeat visits | 1 week and 1 month | Repeat visits to an emergency department |
Countries
United States
Outcome results
None listed