Conditions: Pelvic Pain
Keywords: chronic pain pelvic pain nicotine patch
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 20
Healthy volunteers: no

Brief summary:
The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.

Detailed description:
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.

Arms:
arm 1: Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. arm 2: Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. arm 3: Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.

Interventions: intervention 1: Placebo intervention 2: Nicotine (5 mg) intervention 3: Nicotine (10 mg)
Intervention descriptions: intervention 1: Subjects applied a placebo patch (0 mg) in the morning and removed it at bedtime for one day. intervention 2: Subjects applied a nicotine patch (5 mg) in the morning and removed it at bedtime for one day. intervention 3: Subjects applied a nicotine patch (10 mg) in the morning and removed it at bedtime for one day.

Protocol document: