Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00928564 |
| Other study ID # |
2009-6784 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 2009 |
| Est. completion date |
May 2016 |
Study information
| Verified date |
January 2021 |
| Source |
University of California, Irvine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Pelvic floor tension myalgia (PFTM) is increasingly noted in patients with chronic pelvic
pain. Pelvic floor physical therapy is typically utilized and is at times combined with other
therapies such as botox injections, trigger point injections or pudendal blocks. The
investigators' study will randomize newly diagnosed patients with PFTM to weekly . Final
patient assessment will be performed at 6 months to assess durability of response.
Primary hypothesis: The addition of pudendal blocks to standard pelvic floor physical therapy
will result in lower pain and pelvic floor muscle tension scores, lower baseline vaginal
pressure and increase pelvic floor strength.
Secondary hypothesis: The addition of pudendal blocks to standard pelvic floor physical
therapy will result in a lower pain score in a shorter time frame, resulting in faster
progress through physical therapy.
Description:
Participants will be identified within UC Irvine urogynecology and/or pelvic floor physical
therapy practice with the underlying diagnosis of pelvic floor tension myalgia. This
diagnosis may be secondary to various underlying etiologies including interstitial
cystitis/painful bladder syndrome, vulvodynia, endometriosis, adhesive disease, unknown
etiology, etc. At the time of enrollment, participants will be randomized into one of two
groups: either standard pelvic floor physical therapy with weekly saline placebo injections
or standard pelvic floor physical therapy and weekly pudendal blocks for 6 weeks. Standard
physical therapy techniques will be utilized in both groups. Weekly injections of a mixture
of a steroid and local anesthetic or saline will be administered depending on the
randomization. Injections will be administered by a urogynecology physician. The participant
and the treating physical therapist will be blinded to treatment assignment. The participant
will be evaluated with for pelvic floor muscle strength and tenderness and will have pain
assessed by a visual analog scale at baseline, weekly throughout the study, and at 6 months
after study enrollment. Vaginal electromyography will be performed and standardized
questionnaires regarding pelvic floor symptoms, quality of life and sexual function will be
administered at baseline, after 6 weeks of injections and at 6 months after enrollment.
