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.
Phase:
N/A
Details
Lead Sponsor:
Johns Hopkins University
Collaborators:
Pain Management Institute Bethesda-Washington-Maryland Scilex Pharmaceuticals, Inc. Walter Reed National Military Medical Center Washington D.C. Veterans Affairs Medical Center