Lidocaine Patch for Neck Pain

Neck Pain Clinical Trial

Official title:

Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378959
• Other study ID #: IRB00233514
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: June 2, 2023

Study information

• Verified date: August 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 2, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain
• Neck Pain, Posterior

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Johns Hopkins Blaustein Pain Treatment Center	Baltimore	Maryland
United States	DC VA Medical Center	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins University	Pain Management Institute Bethesda-Washington-Maryland, Scilex Pharmaceuticals, Inc., Walter Reed National Military Medical Center, Washington D.C. Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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

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 — View Citation

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 2 — View Citation

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: 10.1 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Average neck pain score on 0-10 numerical rating scale	Average neck pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain)	4 weeks
Secondary	Mean reduction in worst neck pain score on 0-10 numerical rating scale	Mean reduction in worst 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	Worst neck pain score on 0-10 numerical rating scale	Worst neck pain score over the past week on 0-10 numerical rating scale (higher pain scores represent greater pain)	4 weeks
Secondary	Neck disability index score	Neck disability index score on 0 to 100 percent scale (higher scores represent greater disability)	4 weeks
Secondary	Mean reduction in neck disability index score	Mean reduction in neck disability index score over the past week at week 4 compared to baseline (higher scores represent greater disability)	4 weeks
Secondary	Number of participants with a positive outcome	Positive outcome is defined as a greater than or equal to 2-point decrease in average neck pain on 0-10 NRS scale coupled with a score of greater than or equal to 5 on a 7-point patient global impression of change scale.	4 weeks
Secondary	Patient global impression of change (PGIC) score	1-7 scale evaluating, with higher scores indicating greater improvement.	4 weeks
Secondary	Athens Insomnia Scale score	Scale measuring sleep dysfunction on an 8-question 0-24 scale, with higher numbers indicating greater dysfunction.	4 weeks
Secondary	Hospital Anxiety and Depression Scale score	14-question scale measuring anxiety and depression, with each question scored as 0-3 (higher numbers represent greater anxiety or depression).	4 weeks
Secondary	Pain pressure threshold	Pain pressure threshold, measured via algometry 3 times over the most tender area (mean of 3 measurements)	4 weeks