Clinical Trial: Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Double-Blind, Randomized Study to Compare Onabotulinumtoxin A Versus Kenalog for Intravaginal Trigger Point Injections in the Treatment of Chronic Pelvic Pain

Brief Summary: The goal of this study is to compare the effectiveness of two different medications used in intravaginal trigger point injections (injections into extremely painful areas of a muscle) to treat chronic pelvic pain. The study compares onabotulinumtoxinA (BOTOX®) (a drug prepared from the bacterial toxin botulin which temporarily paralyzes muscles) to Kenalog (a synthetic corticosteroid used as an anti-inflammatory agent).

Detailed Summary: Chronic pelvic pain (CPP) is a common and often debilitating problem among women. The musculoskeletal system is an important factor in chronic pelvic pain. Studies have demonstrated that women with CPP had more frequent musculoskeletal findings. On physical examination, myofascial trigger points have been found. Trigger points are hyperirritable bands of muscle that can be felt from the vaginal wall. They are often knot-like or taut and are painful when pressure is placed on them. Intravaginal injections of these trigger points using steroids including Kenalog (triamcinolone) have been done and produced decreases in pelvic pain. Trigger point injections of Onabotulinumtoxin A has also been shown to decrease pain in subjects with CPP. This study will compare these two drugs and assess pain (using subject questionnaires) at one, three and six months post injection.
Sponsor: Jamie Bartley

Current Primary Outcome:

  • Pain assessed by change in overall pain score using the Visual Analog Scale (VAS) questionnaire. [ Time Frame: One Month ]
    The VAS is a questionnaire that asks subjects to rate their level of pain on a scale from 1-10 with 1 being 'No pain' and 10 being 'Worst pain imaginable'.
  • Pain assessed by change in overall pain and other related scores using the Brief Pain Inventory (BPI) questionnaire. [ Time Frame: One Month ]
    The BPI is a questionnaire that includes information about the location, the severity (0 - No pain - 10 - Pain as bad as you can imagine), the use of pain relief treatments and if pain interfered with activities of daily living and sleep.
  • Pain assessed by change in overall pain and other related scores using the Global Response Assessment (GRA) questionnaire. [ Time Frame: One Month ]
    The GRA is a questionnaire asking subjects to rate pain, bladder, bowel and sexual functions after having the research procedure from 'markedly improved' to 'markedly worse'.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain assessed by change in overall pain score using the Visual Analog Scale (VAS) questionnaire. [ Time Frame: Three Months ]
    The VAS is a questionnaire that asks subjects to rate their level of pain on a scale from 1-10 with 1 being 'No pain' and 10 being 'Worst pain imaginable'.
  • Pain assessed by change in overall pain and other related scores using the Brief Pain Inventory (BPI) questionnaire. [ Time Frame: Three Months ]
    The BPI is a questionnaire that includes information about the location, the severity (0 - No pain - 10 - Pain as bad as you can imagine), the use of pain relief treatments and if pain interfered with activities of daily living and sleep.
  • Pain assessed by change in overall pain and other related scores using the Global Response Assessment (GRA) questionnaire. [ Time Frame: Three Months ]
    The GRA is a questionnaire asking subjects to rate pain, bladder, bowel and sexual functions after having the research procedure from 'markedly improved' to 'markedly worse'.
  • Pain assessed by change in overall pain score using the Visual Analog Scale (VAS) questionnaire. [ Time Frame: Six Months ]
    The VAS is a questionnaire that asks subjects to rate their level of pain on a scale from 1-10 with 1 being 'No pain' and 10 being 'Worst pain imaginable'.
  • Pain assessed by change in overall pain and other related scores using the Brief Pain Inventory (BPI) questionnaire. [ Time Frame: Six Months ]
    The BPI is a questionnaire that includes information about the location, the severity (0 - No pain - 10 - Pain as bad as you can imagine), the use of pain relief treatments and if pain interfered with activities of daily living and sleep.
  • Pain assessed by change in overall pain and other related scores using the Global Response Assessment (GRA) questionnaire. [ Time Frame: Six Months ]
    The GRA is a questionnaire asking subjects to rate pain, bladder, bowel and sexual functions after having the research procedure from 'markedly improved' to 'markedly worse'.


Original Secondary Outcome: Same as current

Information By: William Beaumont Hospitals

Dates:
Date Received: February 5, 2015
Date Started: August 2015
Date Completion: May 2018
Last Updated: March 20, 2017
Last Verified: March 2017