Lidocaine Patch for Neck Pain
Completed · Not applicable · Has a placebo group
Conditions studied: Neck Pain, Neck Pain, Posterior
In brief
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.
Key facts
- Study ID
- NCT04378959
- Run by
- Johns Hopkins University
- People needed
- 76
- Starts
- 2021-02-01
- Expected to finish
- 2023-06-02
- Last updated by the study team
- 2023-08-08
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- DC VA Medical Center — Washington D.C., District of Columbia, United States
- Johns Hopkins Blaustein Pain Treatment Center — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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