DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017