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More info
You can access this
clinical trial
if you have
Pelvic Floor Muscle Spasm
and you are
over 18
years old
-
The phase for this study is not defined.
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The purpose

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 physical therapy with weekly pudendal blocks or placebo saline injection. Participants randomized to physical therapy with placebo injections that have a visual analog scale score of greater than 4 at 6 weeks may cross-over to the pudendal block group. 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.

Provided treatments

  • Drug: Pudendal block
  • Drug: Placebo
Tris trial is registered with FDA with number: NCT00928564. The sponsor of the trial is University of California, Irvine and it is looking for 120 volunteers for the current phase.
Official trial title:
Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia: A Randomized Controlled Cross-over Trial