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N/A N=40 Randomized Double-blind Health Services Research

Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia

Pelvic Floor Muscle Spasm

Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2021
Primary outcome: Primary: Visual Analog Pain Score After 6 Weekly Injections — 3.33; 2.99 Visual Analog Pain Score

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Pudendal block (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
University of California, Irvine
Primary completion
Dec 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Visual Analog Pain Score After 6 Weekly Injections
3.33; 2.99
SECONDARY
Improvement in Pelvic Floor Symptoms as Assessed Through Validated Questionnaires
47.2; 38.2

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00928564). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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