Lidocaine Patch for Neck Pain
Condition: Neck Pain; Neck Pain, Posterior
MeSH terms: Neck Pain
Study type: Interventional

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.
    

Intervention name(s): Lidocaine patch; Placebo patch
Intervention type(s): Drug; Drug
Intervention description(s): 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.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 4 week treatment periods, separated by a 1 to 3 week washout period
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cervicalgia; Neck pain; Lidocaine; Topical