Effect of Nicotine on Chronic Pelvic Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pain Score
研究概览
简要总结
The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.
详细描述
Potential subjects are female non-smokers presenting to their physicians for treatment of chronic pelvic pain. When consented, the subjects fill out a questionnaire on demographic information and pain experience. The trial is conducted at home over three days. Each subject uses three different levels of nicotine (0mg, 5mg, and 10mg) administered in a random order; the study is double-blinded and patients act as their own controls. Subjects apply the placebo or nicotine patches in the morning and remove them in the evening when they fill out a pain diary for the day. During the study, patients will continue their typical course of pain medication and report pain medication use in the pain diary.
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)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chronic pelvic pain
- •Aged 18-60 years
排除标准
- •Uncontrolled hypertension
- •Cardiovascular disease
- •Current analgesic abuse
- •Pregnancy
- •Current usage of nicotine patch or gum
- •Allergy to adhesive tape
研究组 & 干预措施
Placebo
Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day.
干预措施: Placebo (Drug)
Nicotine (5 mg)
Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day.
干预措施: Nicotine (5 mg) (Drug)
Nicotine (10 mg)
Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.
干预措施: Nicotine (10 mg) (Drug)
结局指标
主要结局
Pain Score
时间窗: 1 day
Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.
次要结局
- Patient Self-assessment of Psychological Distress(1 day)
- Number of Participants Who Reported an Increase in Daily Pain Medication Regime(1 day)
- Nausea(1 day)
研究者
Pamela Flood
Professor of Anesthesiology
Columbia University