Back to resultsAdjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients
Primary Purpose
Low Back Pain
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
lidocaine 5% patch
standard therapy
Non-medicated patch
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring lidocaine
Eligibility Criteria
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
Sites / Locations
- John H Stroger Jr Hospital of Cook County
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lidocaine 5% patch
Non-medicated patch
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Numerical Pain Rating Scale (NRS)
Patient description of pain on a scale of 0-10
Secondary Outcome Measures
Roland-Morris-24 back pain disability scale
24 point back pain disability scale
Numerical Pain Rating Scale (NRS)
Patient description of pain on a scale of 0-10
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03301766
Brief Title
Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients
Official Title
Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Delay for subject recruitment and then not feasible with COVID>
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
May 22, 2023 (Actual)
Study Completion Date
May 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cook County Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
lidocaine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine 5% patch
Arm Type
Experimental
Arm Description
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.
Arm Title
Non-medicated patch
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
lidocaine 5% patch
Intervention Description
transdermal patch
Intervention Type
Drug
Intervention Name(s)
standard therapy
Intervention Description
Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)
Intervention Type
Drug
Intervention Name(s)
Non-medicated patch
Intervention Description
non-medicated patch
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale (NRS)
Description
Patient description of pain on a scale of 0-10
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Roland-Morris-24 back pain disability scale
Description
24 point back pain disability scale
Time Frame
1 week and 1 month
Title
Numerical Pain Rating Scale (NRS)
Description
Patient description of pain on a scale of 0-10
Time Frame
1 month
Other Pre-specified Outcome Measures:
Title
Repeat visits
Description
Repeat visits to an emergency department
Time Frame
1 week and 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
24 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients
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