Onabotulinumtoxin A Versus Kenalog for Chronic Pelvic Pain
Information source: William Beaumont Hospitals
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pelvic Pain
Intervention: Onabotulinumtoxin A (Drug); Kenalog (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Jamie Bartley Official(s) and/or principal investigator(s): Jamie Bartley, DO, Principal Investigator, Affiliation: Beaumont
Overall contact: Jamie Bartley, DO, Phone: 248-551-3565
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).
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Pain assessed by change in overall pain score using the Visual Analog Scale (VAS) questionnaire.Pain assessed by change in overall pain and other related scores using the Brief Pain Inventory (BPI) questionnaire. Pain assessed by change in overall pain and other related scores using the Global Response Assessment (GRA) questionnaire.
Secondary outcome: Pain assessed by change in overall pain score using the Visual Analog Scale (VAS) questionnaire.Pain assessed by change in overall pain and other related scores using the Brief Pain Inventory (BPI) questionnaire. Pain assessed by change in overall pain and other related scores using the Global Response Assessment (GRA) questionnaire. Pain assessed by change in overall pain score using the Visual Analog Scale (VAS) questionnaire. Pain assessed by change in overall pain and other related scores using the Brief Pain Inventory (BPI) questionnaire. Pain assessed by change in overall pain and other related scores using the Global Response Assessment (GRA) questionnaire.
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Provide informed consent
- Healthy women > age 18 regardless of menopausal status
- Willing and able to fill out study questionnaires. In patients that are unable to
read, the research nurse will be available to assist.
- High-tone pelvic floor dysfunction on vaginal exam
- A pelvic pain score of > 4 on screening VAS
- Pain perceived to be in the pelvis that has been present for at least 3 months.
Exclusion Criteria:
- Patients that have had Botox to the bladder within the last 8 months
- Patients that have had Botox outside the bladder of > 160 u within the last 12 weeks.
- Patients that have had transvaginal trigger point injections of any form (Botox or
steroid) in the last 3 months
- Pregnancy
- Concomitant use of any narcotic drug, alcohol, or any illicit drug use during the
study period that could be deemed unsafe in combination with study medication as
judged by the investigators.
- Any evidence of vaginitis on wet mount slide at initial visit that is untreated.
- Subject with any other vaginal epithelial disorder that could affect absorption of
medication as deemed by the investigators.
- Any indication/condition/medication that the investigators identify as
contraindicated in conjunction with study medication.
- Systolic blood pressure > 160 mm Hg on screening blood pressure
- Heart rate > 110 beats/minute on screening heart rate
Locations and Contacts
Jamie Bartley, DO, Phone: 248-551-3565
Beaumont Hospitals, Royal Oak, Michigan 48073, United States; Not yet recruiting Maureen Cooney, RN, Phone: 248-551-3565 Wendy J Price, RN, Phone: 248-551-3565
Additional Information
Starting date: August 2015
Last updated: June 22, 2015
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