Clinical trial NCT04378959: Lidocaine Patch for Neck Pain
Official title: Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neck Pain
Neck Pain, Posterior
Keywords: Cervicalgia
Neck pain
Lidocaine
Topical
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Washington D.C. Veterans Affairs Medical Center
name: Pain Management Institute Bethesda-Washington-Maryland
name: Walter Reed National Military Medical Center
name: Scilex Pharmaceuticals, Inc.
First posted: 2020-05-07
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4 week treatment periods, separated by a 1 to 3 week washout period
Primary purpose: TREATMENT

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.

Detailed 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 \</= 3/7.

Eligibility 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

Primary outcomes:
measure: Mean reduction in average neck pain score on 0-10 numerical rating scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Average neck pain score on 0-10 numerical rating scale
timeFrame: 4 weeks
measure: Mean reduction in worst neck pain score on 0-10 numerical rating scale
timeFrame: 4 weeks
measure: Worst neck pain score on 0-10 numerical rating scale
timeFrame: 4 weeks
measure: Neck disability index score
timeFrame: 4 weeks
measure: Mean reduction in neck disability index score
timeFrame: 4 weeks
measure: Number of participants with a positive outcome
timeFrame: 4 weeks
measure: Patient global impression of change (PGIC) score
timeFrame: 4 weeks
measure: Athens Insomnia Scale score
timeFrame: 4 weeks
measure: Hospital Anxiety and Depression Scale score
timeFrame: 4 weeks
measure: Pain pressure threshold
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: DC VA Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Blaustein Pain Treatment Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Steven Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: Cohen SP, Hooten WM. Advances in the diagnosis and management of neck pain. BMJ. 2017 Aug 14;358:j3221. doi: 10.1136/bmj.j3221.
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 Apr 24;8:29. doi: 10.1186/1744-8069-8-29.
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: 10.1097/PHM.0b013e3182645d30.
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 2009 Oct 12.