Lidocaine Patch for Neck Pain

NCT04378959 | Completed

• 1 other identifier: IRB00233514
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Cervicalgia; Neck pain; Lidocaine; Topical

Outcome Measures

Primary Outcomes (1)

• Mean reduction in average neck pain score on 0-10 numerical rating scale

  Mean reduction in average neck pain score over the past week at week 4 compared to baseline on 0-10 numerical rating scale (higher pain scores represent greater pain)

  4 weeks

Secondary Outcomes (10)

• Average neck pain score on 0-10 numerical rating scale

  4 weeks

• Mean reduction in worst neck pain score on 0-10 numerical rating scale

  4 weeks

• Worst neck pain score on 0-10 numerical rating scale

  4 weeks

• Neck disability index score

  4 weeks

• Mean reduction in neck disability index score

  4 weeks

Study Arms (2)

Lidocaine patch first

EXPERIMENTAL

This group will receive up to 3 lidocaine patches for 4 weeks, followed by placebo patches after a 1-3 week washout period.

Drug: Lidocaine patch; Drug: Placebo patch

Placebo patch first

PLACEBO COMPARATOR

This group will receive up to 3 placebo patches for 4 weeks, followed by lidocaine patches after a 1-3 week washout period.

Drug: Lidocaine patch; Drug: Placebo patch

Interventions

Lidocaine patch DRUG

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.

Lidocaine patch first; Placebo patch first

Placebo patch DRUG

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.

Lidocaine patch first; Placebo patch first

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Washington D.C. Veterans Affairs Medical Center: collaborator
• Pain Management Institute Bethesda-Washington-Maryland: collaborator
• Walter Reed National Military Medical Center: collaborator
• Scilex Pharmaceuticals, Inc.: collaborator

Study Sites (2)

DC VA Medical Center

Washington D.C., District of Columbia, 20422, United States

Location

Johns Hopkins Blaustein Pain Treatment Center

Baltimore, Maryland, 21205, United States

Location

Related Publications (5)

• Predel HG, Giannetti B, Pabst H, Schaefer A, Hug AM, Burnett I. Efficacy and safety of diclofenac diethylamine 1.16% gel in acute neck pain: a randomized, double-blind, placebo-controlled study. BMC Musculoskelet Disord. 2013 Aug 21;14:250. doi: 10.1186/1471-2474-14-250.

  PMID: 23964752 BACKGROUND

• Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.

  PMID: 28807894 RESULT

• Hashmi JA, Baliki MN, Huang L, Parks EL, Chanda ML, Schnitzer T, Apkarian AV. Lidocaine patch (5%) is no more potent than placebo in treating chronic back pain when tested in a randomised double blind placebo controlled brain imaging study. Mol Pain. 2012 Apr 24;8:29. doi: 10.1186/1744-8069-8-29.

  PMID: 22531485 RESULT

• Lin YC, Kuan TS, Hsieh PC, Yen WJ, Chang WC, Chen SM. Therapeutic effects of lidocaine patch on myofascial pain syndrome of the upper trapezius: a randomized, double-blind, placebo-controlled study. Am J Phys Med Rehabil. 2012 Oct;91(10):871-82. doi: 10.1097/PHM.0b013e3182645d30.

  PMID: 22854911 RESULT

• Hsieh LF, Hong CZ, Chern SH, Chen CC. Efficacy and side effects of diclofenac patch in treatment of patients with myofascial pain syndrome of the upper trapezius. J Pain Symptom Manage. 2010 Jan;39(1):116-25. doi: 10.1016/j.jpainsymman.2009.05.016. Epub 2009 Oct 12.

  PMID: 19822404 RESULT

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Cohen, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical lidocaine and placebo patches will be provided to research pharmacies at participating sites, along with site-specific randomization tables. Care providers, investigators, patients and outcome assessors will all be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 week treatment periods, separated by a 1 to 3 week washout period

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: February 1, 2021
• Primary Completion: June 2, 2023
• Study Completion: June 2, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: After publication, for at least 3 years
• Access Criteria: Request, including objectives, to the Overall PI (SP Cohen)

Locations

US (2)