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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on September 30, 2014