Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia
Completed · Not applicable · Has a placebo group
Conditions studied: Pelvic Floor Muscle Spasm
In brief
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.
Key facts
- Study ID
- NCT00928564
- Run by
- University of California, Irvine
- People needed
- 40
- Starts
- 2009-04-01
- Expected to finish
- 2016-05-01
- Last updated by the study team
- 2021-02-10
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Non-pregnant women over the age of 18 with the diagnosis of pelvic floor tension myalgia that are naive to pelvic floor physical therapy.
- Able to provide informed consent.
- Subjects must be willing to accept randomization.
You may not qualify if…
- Previously treated with physical therapy.
- An allergy to any component within the pudendal block.
- Bleeding disorders.
- Active vaginal infection.
- Inability to complete the questionnaires.
- Inability to read English (validated questionnaires are available in English only).
- Inability to complete the follow-up visits.
Where it is running
- UCI Women's Healthcare — Orange, California, United States
Full record on ClinicalTrials.gov
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