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NCT00928564 · ClinicalTrials.gov registry record · NA
Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia
A NA study of Pelvic Floor Muscle Spasm, sponsored by University of California, Irvine.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00928564: Completed NA study of Pelvic Floor Muscle Spasm, sponsored by University of California, Irvine.
NCT00928564 is a NA study of Pelvic Floor Muscle Spasm that has completed, run by University of California, Irvine. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00928564, a NA study of Pelvic Floor Muscle Spasm, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
10 point likert scale to report pain a score from zero for no pain to ten for the worst possible pain
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pudendal block
Study Locations (1)
California
- UCI Women's Healthcare - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-04 |
| Est. Completion | 2016-05 |
| Phase | NA |
What the finished NCT00928564 record still lists
NCT00928564 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Pelvic Floor Muscle Spasm appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00928564 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00928564 about?
NCT00928564 is a clinical study titled "Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia". 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 rando...
What is the current status of trial NCT00928564?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2009-04. Estimated completion is 2016-05.
What conditions does trial NCT00928564 study?
This clinical trial studies the following conditions: Pelvic Floor Muscle Spasm.
What interventions are being tested in trial NCT00928564?
The interventions under investigation include: Placebo (DRUG), Pudendal block (DRUG).
Who is sponsoring clinical trial NCT00928564?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00928564 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00928564's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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