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 ]

Pain assessment by patient reported in visual analog score (VAS) with 0=no pain and 10=worst pain.


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