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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 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. The trial reports 1 study location across 1 state.

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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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Pudendal block

Study Locations (1)

California

  • UCI Women's Healthcare - Orange

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2009-04
Est. Completion 2016-05
Phase NA

Sponsor

University of California, Irvine

368 total trials

What the Registry Record Tells You About NCT00928564

The ClinicalTrials.gov registry entry for NCT00928564 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.