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Lidocaine Patch for Neck Pain

NCT04378959 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-08-08

No results posted yet for this study

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.

Conditions

  • Neck Pain
  • Neck Pain, Posterior

Interventions

DRUG

Lidocaine patch

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.

DRUG

Placebo patch

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.

Sponsors & Collaborators

  • Washington D.C. Veterans Affairs Medical Center

    collaborator FED

  • Pain Management Institute Bethesda-Washington-Maryland

    collaborator UNKNOWN

  • Walter Reed National Military Medical Center

    collaborator FED

  • Scilex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Steven Cohen, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2023-06-02
Completion
2023-06-02

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04378959 on ClinicalTrials.gov