Clinical Trial: Effect of Nicotine on Chronic Pelvic Pain
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Effect of Nicotine on Chronic Pelvic Pain
Brief Summary: The purpose of this study is to test whether transdermal nicotine reduces pain among women with chronic pelvic pain.
Detailed Summary: 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.
Sponsor: Columbia University
Current Primary Outcome: Pain Score [ Time Frame: 1 day ]
Original Primary Outcome:
- VAS daily pain scores
- McGill sensory and affective daily pain scores
Current Secondary Outcome:
- Patient Self-assessment of Psychological Distress [ Time Frame: 1 day ]Patient self-assessment of psychological distress in brief rating scale with no psychological distress=0 and maximum psychological distress=90.
- Number of Participants Who Reported an Increase in Daily Pain Medication Regime [ Time Frame: 1 day ]Number of participants who reported increases in daily pain medication after treatment with each intervention compared to their normal daily pain medication regime.
- Nausea [ Time Frame: 1 day ]Nausea assessment by patient reported on a numerical rating scale (NRS) with 0=no nausea and 10=extreme nausea.
Original Secondary Outcome:
Information By: Columbia University
Dates:
Date Received: February 26, 2007
Date Started: February 2004
Date Completion:
Last Updated: January 12, 2011
Last Verified: January 2011