Ignite Creation Date:
2025-12-24 @ 2:25 PM
Ignite Modification Date:
2025-12-25 @ 1:00 PM
Study NCT ID:
NCT04378959
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2020-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lidocaine Patch for Neck Pain
Sponsor:
Johns Hopkins University
Organization:
Study Overview
Official Title:
Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain.
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this randomized, double-blind, placebo-controlled crossover study, up to 84 patients with non-radicular neck pain will be allocated in a 1:1 ratio to receive up to 3 topical lidocaine or placebo patches, to be applied 12 hours per day. At the end of 4 weeks, patients will return for patients' post-phase I treatment evaluation. Patients will crossover to receive up to 3 identical-looking topical patches of the treatment patients did not receive, to be applied in the same fashion for the same 4-week period. The primary outcome measure will be average neck pain over the past week, 4 weeks post-treatment. A positive categorical outcome (i.e. responder) will be defined as a 2-point or greater decrease in average neck pain coupled with a patient global impression of change score \>/= 5/7.
Detailed Description:
84 patients will be allocated to receive lidocaine patch or an identical placebo patch for phase I of this crossover study. Depending on the area of pain, up to 3 patches can be applied. Patches will be applied for 12 hours on and 12 hours off (e.g. from 8 PM to 8 AM or 8 AM to 8PM) depending on whether a person's pain is worse in the day or night.
At the end of 4 weeks of treatment, patients will return to clinic for the post-phase I treatment evaluation, at which time outcome measures will be collected. Patients will then enter a 1-week washout period, after which patients will return between 1 and 3 weeks (depending on patients' availability) to receive the treatment patch patients did not receive in phase I (i.e. lidocaine for group II patients and placebo for group I patients). The short washout period is justifiable based on the short half-life of lidocaine (90-120 minutes) and is consistent with previous topical lidocaine crossover studies. The crossover patch will be applied in the same fashion as in the 1st phase, again for a 4-week duration.
In order to reduce confounding variables, subjects in both groups must agree to not seek any additional pain management treatment as long as patients remain in the study. However, some treatments, such as physical therapy or exercise that are widely recommended can continue, so patients will be told to advise patients' pain clinic physician of any new treatments patients wish to seek during this time period. Subjects will be also be advised that patients can be prescribed rescue medications in the form of a non-steroidal anti-inflammatory drug or acetaminophen, or tramadol (up to 100 mg/d) for those who have already failed a non-steroidal anti-inflammatory drug and acetaminophen, or cannot take the drugs for medical reasons (e.g. renal disease, high cardiovascular risk).
The primary outcome measure will be average neck pain over the past week, 4 weeks post-treatment. A positive categorical outcome (i.e. responder) will be defined as a 2-point or greater decrease in average neck pain coupled with a patient global impression of change score \</= 3/7.
At the end of 4 weeks of treatment, patients will return to clinic for the post-phase I treatment evaluation, at which time outcome measures will be collected. Patients will then enter a 1-week washout period, after which patients will return between 1 and 3 weeks (depending on patients' availability) to receive the treatment patch patients did not receive in phase I (i.e. lidocaine for group II patients and placebo for group I patients). The short washout period is justifiable based on the short half-life of lidocaine (90-120 minutes) and is consistent with previous topical lidocaine crossover studies. The crossover patch will be applied in the same fashion as in the 1st phase, again for a 4-week duration.
In order to reduce confounding variables, subjects in both groups must agree to not seek any additional pain management treatment as long as patients remain in the study. However, some treatments, such as physical therapy or exercise that are widely recommended can continue, so patients will be told to advise patients' pain clinic physician of any new treatments patients wish to seek during this time period. Subjects will be also be advised that patients can be prescribed rescue medications in the form of a non-steroidal anti-inflammatory drug or acetaminophen, or tramadol (up to 100 mg/d) for those who have already failed a non-steroidal anti-inflammatory drug and acetaminophen, or cannot take the drugs for medical reasons (e.g. renal disease, high cardiovascular risk).
The primary outcome measure will be average neck pain over the past week, 4 weeks post-treatment. A positive categorical outcome (i.e. responder) will be defined as a 2-point or greater decrease in average neck pain coupled with a patient global impression of change score \</= 3/7.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: