A Phase 4 interventional study of lidocaine 5% patch and standard therapy in Low Back Pain, sponsored by Cook County Health. Withdrawn at 1 site in United States. Open to participants aged 24 Years to 64 Years. Per ClinicalTrials.gov, last updated 2023-06-29.
Sponsored by Cook County Health · Phase 4, Interventional, and Treatment
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.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
Browse Low Back Pain studies →Cook County Health is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: lidocaine 5% patch · Drug: standard therapy
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.
Drug: standard therapy · Drug: Non-medicated patch
transdermal patch
Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)
non-medicated patch
Numerical Pain Rating Scale (NRS)
Patient description of pain on a scale of 0-10
Time frame: 1 week
Roland-Morris-24 back pain disability scale
24 point back pain disability scale
Time frame: 1 week and 1 month
Numerical Pain Rating Scale (NRS)
Patient description of pain on a scale of 0-10
Time frame: 1 month
Repeat visits
Repeat visits to an emergency department
Time frame: 1 week and 1 month
Plan to share: No
No publications or documents are linked to this record.
Ran from Mar 2017 to primary completion in May 2023, 74 months.
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This study is withdrawn, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Lidocaine
Cook County Health