Randomized, Placebo-controlled Crossover Trial Evaluating Topical Lidocaine Patch(es) for Mechanical Neck Pain.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Mean reduction in average neck pain score on 0-10 numerical rating scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Lidocaine patch first
This group will receive up to 3 lidocaine patches for 4 weeks, followed by placebo patches after a 1-3 week washout period.
干预措施: Lidocaine patch (Drug)
Lidocaine patch first
This group will receive up to 3 lidocaine patches for 4 weeks, followed by placebo patches after a 1-3 week washout period.
干预措施: Placebo patch (Drug)
Placebo patch first
This group will receive up to 3 placebo patches for 4 weeks, followed by lidocaine patches after a 1-3 week washout period.
干预措施: Lidocaine patch (Drug)
Placebo patch first
This group will receive up to 3 placebo patches for 4 weeks, followed by lidocaine patches after a 1-3 week washout period.
干预措施: Placebo patch (Drug)
结局指标
主要结局
Mean reduction in average neck pain score on 0-10 numerical rating scale
时间窗: 4 weeks
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)
次要结局
- 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)
- Average 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)
- Number of participants with a positive outcome(4 weeks)
- Patient global impression of change (PGIC) score(4 weeks)
- Athens Insomnia Scale score(4 weeks)
- Hospital Anxiety and Depression Scale score(4 weeks)
- Pain pressure threshold(4 weeks)