Lidocaine Patch for Neck Pain
Lidocaine Patch for Neck Pain
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.
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