Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain

This study is currently recruiting participants.
Verified July 2013 by Boston Urogynecology Associates
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Sybil Dessie, MD, Boston Urogynecology Associates
ClinicalTrials.gov Identifier:
NCT01905137
First received: July 18, 2013
Last updated: July 23, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to determine whether there is a change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.


Condition Intervention
Myofascial Pelvic Pain
Drug: Intervention-Botulinum Toxin Type A
Drug: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain

Resource links provided by NLM:


Further study details as provided by Boston Urogynecology Associates:

Primary Outcome Measures:
  • To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline. [ Time Frame: 2 weeks after pelvic floor injection ] [ Designated as safety issue: No ]
    To test this hypothesis we will measure patient-reported pain on palpation of each levator ani muscle group at baseline and two weeks following the injection. Pain will be assessed on a 10-point visual analog scale. We will compare the baseline and two-week pain measurements for the most painful muscle group.


Secondary Outcome Measures:
  • To evaluate the change in patient-reported pelvic pain following Botox injections in conjunction with pelvic floor physical therapy compared to saline injections with physical therapy. [ Time Frame: 12 weeks following pelvic floor injection ] [ Designated as safety issue: No ]
    To test this we will measure patient-reported pain on palpation of each levator ani muscle group at baseline and 12 weeks following the injection. Pain will be assessed on a 10-point visual analog scale. We will compare the baseline and 12-week pain measurements for the most painful muscle group.


Estimated Enrollment: 64
Study Start Date: July 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botulinum Toxin Type A
Patients in the treatment group will receive 200 Units of Botulinum toxin diluted in 20 mL of saline injected globally into their pelvic floor muscles followed by 8 treatments of pelvic floor physical therapy.
Drug: Intervention-Botulinum Toxin Type A
Patients will receive 200 units of Botulinum Toxin A diluted in 20 mL of preservative free saline to their pelvic floor followed by pelvic floor physical therapy.
Other Name: Botox
Placebo Comparator: Saline
Patients in the placebo group will receive 20 mL of saline injected globally into their pelvic floor muscles followed by 8 treatments of pelvic floor physical therapy.
Drug: placebo
Other Name: saline

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 18
  • Diagnosis of myofascial pain by an attending urogynecologist
  • Persistent pelvic pain present for ≥50% of days over the past 3 months at a level of 6 or greater on a 10-point visual analog scale
  • On physical exam, a short, tight pelvic floor with pain on palpation of at least 6 on a 10-point visual analog scale in at least one muscle group (coccygeus, pyriformis, obturator internus, iliococcygeus, puborectalis, or pubococcygeus).
  • Ability to read English, provide written, informed consent and be able and willing to go to pelvic floor physical therapy.

Exclusion Criteria:

  • Pregnancy or breastfeeding
  • Any of the following a pre-existing neurologic or neuromuscular condition that precludes them from Botox injections, such as myasthenia gravis, a bleeding disorder; or sensitivity or allergy to Botox
  • Current use of aminoglycosides or any other medication that may potentiate the neuromuscular weakness that could be caused by concomitant use of Botox also will be ineligible
  • History of treatment with Botox to the pelvic floor
  • Presence of any masses or lesions on physical exam
  • Pelvic organ prolapse greater than stage 2
  • Plan for pelvic floor surgery or pelvic floor physical therapy treatment in the next three months
  • Previous trigger point injections to the pelvic floor
  • Change in pain medication usage in the past 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01905137

Contacts
Contact: Kathy Rogers 617-354-5452 krogers2@mah.harvard.edu

Locations
United States, Massachusetts
Boston Urogynecology Associates Recruiting
Cambridge, Massachusetts, United States, 02138
Contact: Kathy Rogers    617-354-5452    krogers2@mah.harvard.edu   
Principal Investigator: Eman A Elkadry, MD         
Sub-Investigator: Sybil G Dessie, MD         
Sub-Investigator: Kathy Rogers         
Sponsors and Collaborators
Boston Urogynecology Associates
Allergan
Investigators
Principal Investigator: Eman A Elkadry, MD Mount Auburn Hospital
  More Information

No publications provided

Responsible Party: Sybil Dessie, MD, Clinical Instructor, Boston Urogynecology Associates
ClinicalTrials.gov Identifier: NCT01905137     History of Changes
Other Study ID Numbers: 015-2013
Study First Received: July 18, 2013
Last Updated: July 23, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Boston Urogynecology Associates:
Myofascial pelvic pain

Additional relevant MeSH terms:
Botulinum Toxins, Type A
Botulinum Toxins
Pelvic Pain
Pain
Signs and Symptoms
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014