Lidocaine Patch for Neck Pain

Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain.

Washington D.C. Veterans Affairs Medical Center, Pain Management Institute Bethesda-Washington-Maryland, Walter Reed National Military Medical Center, Scilex Pharmaceuticals, Inc.

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.

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.

Identical lidocaine and placebo patches will be provided to research pharmacies at participating sites, along with site-specific randomization tables. Care providers, investigators, patients and outcome assessors will all be blinded to treatment allocation.

This group will receive up to 3 lidocaine patches for 4 weeks, followed by placebo patches after a 1-3 week washout period.

This group will receive up to 3 placebo patches for 4 weeks, followed by lidocaine patches after a 1-3 week washout period.

Up to 3 patches will be applied for 12 hours on (e.g. from 8 AM to 8 PM for those whose pain is worse during the day, or from 8 PM to 8 AM for those whose pain is worse at night) and 12 hours off x 4 weeks.

Up to 3 patches will be applied for 12 hours on (e.g. from 8 AM to 8 PM for those whose pain is worse during the day, or from 8 PM to 8 AM for those whose pain is worse at night) and 12 hours off x 4 weeks.

Mean reduction in average neck pain score over the past week at week 4 compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain)

Average neck pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain)

Mean reduction in worst neck pain score over the past week at week 4 compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain)

Worst neck pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain)

Mean reduction in neck disability index score over the past week at week 4 compared to baseline (higher scores represent greater disability)

Positive outcome is defined as a greater than or equal to 2-point decrease in average neck pain on 0-10 NRS scale coupled with a score of greater than or equal to 5 on a 7-point patient global impression of change scale.

Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.

14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).

Pain pressure threshold, measured via algometry 3 times over the most tender area (mean of 3 measurements)

Inclusion Criteria: Age 18 to 90 years Tenderness to palpation over affected areas (using average 4 kg force for 70 kg person) Average pain score >/= 4 over the week prior to enrollment On stable doses of analgesics for 2 weeks prior to enrollment Chronic mechanical neck pain > 3 months in duration Boundaries are upper trapezius, mastoid processes, shoulders Exclusion Criteria: Radicular pain as determined by clinical presentation Opioid dose in oral morphine equivalents/day > 30 Moderate or severe hepatic disease (will obtain blood work and exclude individuals with aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 3 times the normal range. Previous neck surgery Known structural defect presumed to be the primary pain generator (e.g. severe degenerative disc or facet joint disease) Serious medical (e.g. unstable angina) or psychiatric (e.g. poorly controlled depression, active substance abuse) that could interfere with treatment or pain response Secondary gain Pregnancy or breastfeeding painDETECT score > 18 Known allergy to lidocaine Diffuse pain phenotype (e.g. fibromyalgia) Cervical pain greater in area than 3 patches (10 x 14 cm/patch) Skin defects (e.g. burns, active infection) in area(s) of application that could result in significant systemic absorption

The protocol, and de-identified data may be shared with other researchers, pending approval (if relevant) from the Dept. of Defense (Walter Reed) and VA (DC VA Hospital)

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