N/A
N=40
Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia
Pelvic Floor Muscle Spasm
Bottom Line
View on ClinicalTrials.gov: NCT00928564 ↗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
| Outcome | Result | p-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.
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.