Low Back PainPhase 4NCT03301766
Adjunctive 5% Lidocaine Patches for Acute Non-radicular Low Back Pain in Emergency Department Patients
A Phase 4 study testing lidocaine 5% patch, standard therapy and Non-medicated patch in people with Low Back Pain, run by Cook County Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 64 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- lidocaine 5% patch, standard therapy and Non-medicated patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2017to 22 May 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- pain originating between the lower border of the scapulae and the upper gluteal folds
- treating ED physician plan for discharge of the patient
Who cannot join
- 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)
Show all 9Show fewer
- personal history of malignancy, fever (temperature greater than 37.9ºC), or previous spinal surgery
- patients who are detainees
- previous enrollment in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
About this study
Official title: Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- lidocaine 5% patch, standard therapy, Non-medicated patch
- Keywords
- lidocaine
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaine 5% patchDrug
transdermal patch
standard therapyDrug
Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)
Non-medicated patchDrug
non-medicated patch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: lidocaine 5% patch; Drug: standard therapy |
| 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. Receives: Drug: standard therapy; Drug: Non-medicated patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Pain Rating Scale (NRS)
Patient description of pain on a scale of 0-10
Measured: 1 week
Secondary outcomes (2)
Roland-Morris-24 back pain disability scale
24 point back pain disability scale
Measured: 1 week and 1 month
Numerical Pain Rating Scale (NRS)
Patient description of pain on a scale of 0-10
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start10 Mar 2017
- Primary completion22 May 2023
- Study completion22 May 2023
Why it stopped: Delay for subject recruitment and then not feasible with COVID\>
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cook County Health
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Neeraj Chhabra, Cook County Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03301766
- Sponsor's protocol ID
- 17-510
- Status last verified
- Jun 2023
- First submitted
- 29 Sep 2017
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive 5% Lidocaine Patches in the Treatment of Acute Non-radicular Low Back Pain in Patients Discharged From the Emergency Department
- ClinicalTrials.gov ID
- NCT03301766
- Acronym / sponsor ID
- 17-510
- Conditions
- Low Back Pain
- Keywords
- lidocaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Delay for subject recruitment and then not feasible with COVID\>
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Cook County HealthOther government
- Study start
- 10 Mar 2017 (actual)
- Primary completion
- 22 May 2023 (actual)
- Study completion
- 22 May 2023 (actual)
- First posted
- 4 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 5% patch | Experimental | Drug: lidocaine 5% patch, Drug: standard therapyPatients 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 | Drug: standard therapy, Drug: Non-medicated patchPatients 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. |
Who may qualify
- Ages
- 24 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pain originating between the lower border of the scapulae and the upper gluteal folds
- treating ED physician plan for discharge of the patient
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocaine 5% patchtransdermal patch | Drug | Lidocaine 5% patch |
| standard therapyDrugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc) | Drug | Lidocaine 5% patch, Non-medicated patch |
| Non-medicated patchnon-medicated patch | Drug | Non-medicated patch |
Primary outcome
Numerical Pain Rating Scale (NRS)
Time frame: 1 week
Patient description of pain on a scale of 0-10
2 secondary outcomes
Roland-Morris-24 back pain disability scale
Time frame: 1 week and 1 month
Numerical Pain Rating Scale (NRS)
Time frame: 1 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lidocaine 5% patch, standard therapy and Non-medicated patch in people with Low Back Pain, run by Cook County Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NRS) (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.