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

NCT01905137 | Unknown

• 1 other identifier: 015-2013
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myofascial Pelvic Pain

Keywords

Myofascial pelvic pain

Outcome Measures

Primary Outcomes (1)

• To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.

  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.

  2 weeks after pelvic floor injection

Secondary Outcomes (1)

• 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.

  12 weeks following pelvic floor injection

Study Arms (2)

Botulinum Toxin Type A

ACTIVE COMPARATOR

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

Saline

PLACEBO COMPARATOR

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

Interventions

Intervention-Botulinum Toxin Type A DRUG

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.

Also known as: Botox

Botulinum Toxin Type A

placebo DRUG

Also known as: saline

Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Change in pain medication usage in the past 3 months

Sponsors & Collaborators

• Boston Urogynecology Associates: lead
• Allergan: collaborator

Study Sites (1)

Boston Urogynecology Associates

Cambridge, Massachusetts, 02138, United States

Location

Related Publications (1)

• Dessie SG, Von Bargen E, Hacker MR, Haviland MJ, Elkadry E. A randomized, double-blind, placebo-controlled trial of onabotulinumtoxin A trigger point injections for myofascial pelvic pain. Am J Obstet Gynecol. 2019 Nov;221(5):517.e1-517.e9. doi: 10.1016/j.ajog.2019.06.044. Epub 2019 Jun 27.

  PMID: 31254522 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A; Sodium Chloride

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Eman A Elkadry, MD

  Mount Auburn Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: March 9, 2018
• Study Completion: June 1, 2019
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

US (1)