Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain
Primary Purpose
Myofascial Pelvic Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention-Botulinum Toxin Type A
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Myofascial Pelvic Pain focused on measuring Myofascial pelvic pain
Eligibility 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
- Change in pain medication usage in the past 3 months
Sites / Locations
- Boston Urogynecology Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Botulinum Toxin Type A
Saline
Arm Description
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.
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.
Outcomes
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.
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.
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.
Full Information
NCT ID
NCT01905137
First Posted
July 18, 2013
Last Updated
April 11, 2019
Sponsor
Boston Urogynecology Associates
Collaborators
Allergan
1. Study Identification
Unique Protocol Identification Number
NCT01905137
Brief Title
Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain
Official Title
Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (Actual)
Primary Completion Date
March 9, 2018 (Actual)
Study Completion Date
June 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston Urogynecology Associates
Collaborators
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Objective:
Primary objective: To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.
Secondary objective: 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.
Hypothesis We hypothesize that women in the Botox treatment arm, compared with those in the saline arm, will have a greater decrease in patient-reported pain on palpation of their most painful levator ani muscle group at two weeks after the injection.
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.
We hypothesize that with the addition of physical therapy, women in the Botox treatment arm, compared with those in the saline arm, have a greater decrease in patient-reported pain on palpation of their most painful levator ani muscle group at 12 weeks after the injection.
To test this hypothesis 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.
Intervention:
All patients will be screened for eligibility during their routine office visit. If they meet all eligibility criteria, they will be offered enrollment. At this visit, all patients will be counseled about conservative treatment options for dealing with irritative voiding symptoms, bowel symptoms, and pain. The counseling offered will be standardized for all patients. After patients are consented, they will undergo an initial evaluation with a pelvic floor physical therapist. Patients will then return for an office visit to receive their treatment. The patients will be pretreated with 100mg of topical Lidocaine hydrochloride jelly, 2%, in the vagina for 15 minutes prior to their injections. A designated medical assistant will open an opaque sealed envelope to determine whether the patient is randomized to the Botox or saline arm. The medical assistant will draw up the appropriate solution-either 20mL of saline or 200 units of Botox A diluted in preservative-free saline, to achieve a concentration of 10 units per mL. Both the Botox and saline will be drawn into 2 unlabeled 10mL syringes in order to ensure the physician remains blinded to treatment arm assignment. The saline or Botox will be injected to the coccygeus, piriformis, obturator internus, puborectalis, iliococcygeus, and pubococcygeus muscles bilaterally for a total of 1-2mL per muscle group. Using digital vaginal palpation, the muscles to be injected will be located with care taken to locate tender and contracted points on the muscle fibers. The index finger is used for palpation as the 20-gauge pudendal block needle with the guide is advanced to the target site piercing through the vaginal mucosa to the intended muscle groups. The needle is placed into the intended muscles under direct palpation for injection of 1-2mL aliquots.
Study Design:
This is a double-blinded, randomized controlled trial. Participants will be randomized to either Botox or saline in a ratio of 1:1 using computer-generated block randomization. The statistician will create the sequentially numbered opaque sealed envelopes to conceal group assignment.Study visits Baseline visit Once determined eligible, patients will be offered enrollment into the study. After consent forms are signed, we will obtain study data. Participants will then see a physical therapist at a designated pelvic floor physical therapy center to evaluate their pelvic floor prior to any intervention.
Injection visit Following the pelvic floor physical therapy assessment, participants will return to the urogynecology office for their injection of saline or Botox as specified above.
Two-week post-injection visit At two weeks, patients will return for outcome assessments. Four-week post-injection visit Patients will return at 4 weeks for the same outcome assessment they had at 2 weeks. After the 4-week visit, participants will start pelvic floor physical therapy. They will go to physical therapy for a total of 8 sessions, done as close to weekly as possible.
Twelve-week post-injection visit At 12 weeks patients will return for outcome assessments. After all outcome data are collected, the provider and the patient will be unblinded. Patients who were randomized to the placebo group will be offered 200 Units of Botox injection at no cost. These 32 patients will be encouraged to continue with weekly physical therapy for 8 weeks following the Botox injection. We will ask these participants to return at 2 weeks and 12 weeks after the injection for outcome assessments. During these visits we will collect the same data as for the 2-week and 12-week visits.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myofascial Pelvic Pain
Keywords
Myofascial pelvic pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Botulinum Toxin Type A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Intervention-Botulinum Toxin Type A
Other Intervention Name(s)
Botox
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
saline
Primary Outcome Measure Information:
Title
To evaluate the change in patient-reported pelvic pain following pelvic floor injections of 200 units of Botox compared with 20cc of normal saline.
Description
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.
Time Frame
2 weeks after pelvic floor injection
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
12 weeks following pelvic floor injection
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Change in pain medication usage in the past 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman A Elkadry, MD
Organizational Affiliation
Mount Auburn Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Urogynecology Associates
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02138
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31254522
Citation
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.
Results Reference
derived
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Botulinum Toxin Type A Versus Saline Trigger Point Injections for Myofascial Pelvic Pain
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