Preventive Effect of 5% Lidocaine Plaster on the Development of Neuropathic Pain Following Osteoporotic Vertebral Fracture: A Proof-of-concept, Controlled, Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Development of neuropathic pain at 2 months
研究概览
简要总结
Osteoporotic vertebral fractures may lead to chronic pain with a neuropathic component, which is often underdiagnosed and undertreated in older adults. This proof-of-concept randomized controlled trial aims to evaluate whether early application of a 5% lidocaine plaster can prevent the development of neuropathic pain following an osteoporotic vertebral fracture. Participants will be randomized in a 2:1 ratio to receive either a daily 5% lidocaine plaster plus standard care or standard care alone for 2 months. The primary outcome is the proportion of participants who develop neuropathic pain at 2 months, assessed using the PainDETECT questionnaire.
详细描述
Osteoporosis is associated with an increased risk of vertebral fractures that may result in persistent pain and impaired quality of life. Beyond nociceptive pain, a substantial proportion of patients develop neuropathic pain after osteoporotic vertebral fractures, which is associated with greater pain severity, sleep disturbances, and functional impairment. Current management often identifies neuropathic pain only after it has become chronic, while systemic treatments may increase the risk of adverse events in older adults.
The FLYNN study is a prospective, randomized, controlled, open-label, proof-of-concept Phase 2 clinical trial designed to evaluate whether early treatment with a 5% lidocaine plaster can prevent the development of neuropathic pain following an osteoporotic vertebral fracture. Participants aged 50 years or older with a vertebral osteoporotic fracture diagnosed within the previous month and pain intensity ≥3 on a numerical rating scale will be randomized in a 2:1 ratio to receive either daily treatment with a 5% lidocaine plaster (12 hours on/12 hours off) plus standard care or standard care alone for 2 months.
The primary endpoint is the occurrence of neuropathic pain 2 months after enrollment, defined by a PainDETECT score ≥19. Secondary outcomes include neuropathic pain assessed by DN4, pain intensity, treatment compliance, adverse events, concomitant medications, sleep quality (PSQI), health-related quality of life (SF-36), and psychophysical pain characterization in participants who develop neuropathic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participant aged 50 years or older.
- •Diagnosis of osteoporosis established by the treating rheumatologist.
- •Osteoporotic vertebral fracture diagnosed within the previous month.
- •Pain intensity of ≥3 on a numerical rating scale at the fracture site.
- •Able and willing to provide written informed consent.
- •Affiliated with a French health insurance system.
排除标准
- •Medical or surgical condition considered by the investigator to be incompatible with study participation.
- •Known hypersensitivity to lidocaine, any excipient of the study treatment, or other amide-type local anesthetics.
- •Current treatment with Class I antiarrhythmic agents (e.g., tocainide, mexiletine) or other local anesthetics.
- •Inflamed or damaged skin at the intended application site (e.g., active herpes zoster lesions, dermatitis, or wounds).
- •Pregnant or breastfeeding women.
- •Women of childbearing potential not using an effective contraceptive method.
- •Positive urine pregnancy test for women whose menopausal status cannot be confirmed.
- •Participation in another clinical research study.
- •Individuals under legal protection or deprived of liberty.
- •Refusal to participate.
结局指标
主要结局
Development of neuropathic pain at 2 months
时间窗: Baseline - Day 0 and Visit 2 - Day 60
Percentage of participants who develop neuropathic pain 2 months after enrollment, assessed using the PainDETECT questionnaire. This self-administered questionnaire evaluates pain quality, temporal pattern, and radiation to estimate the likelihood of neuropathic pain. The total score allows classification of pain as unlikely, possible, or likely neuropathic. Neuropathic pain is defined as a PainDETECT score ≥19.
次要结局
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline - Day 0 and Visit 2 - Day 60)
- The 36-Item Short Form Survey (SF-36)(Baseline - Day 0 and Visit 2 - Day 60)
- Pain assessment using the Neuropathic Pain Questionnaire (DN4)(Baseline - Day 0 and Visit 2 - Day 60)
- Treatment compliance(Day 1 to Day 60)
- Adverse events(Day 1 to Day 60)
- Pain evaluation(Baseline - Day 0, Day 1 to Day 60, and Visit 2 - Day 60)
- Concomitant medications(Day 1 to Day 60)
- Measurement of the threshold of sensitivity and pain perception induced by a thermal stimulus (hot and cold) at the Pathway - Médoc®(Visit 2 - Day 60)
- Central sensitization tests, measurement of the Conditioned Pain Modulation (CPM) effect(Visit 2 - Day 60)