Lidocaine Patch for Neck Pain

• Status: Recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

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
• Treatments: Lidocaine

Criteria

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