Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2009 |
| End Date: | December 2015 |
| Contact: | Felicia Lane, MD |
| Email: | fgeas@uci.edu |
| Phone: | 714.456.8564 |
Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia: A Randomized Controlled Cross-over Trial
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.
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.
Participants will be identified within UC Irvine urogynecology and/or pelvic floor physical
therapy practice with the underlying diagnosis of pelvic floor tension myalgia. This
diagnosis may be secondary to various underlying etiologies including interstitial
cystitis/painful bladder syndrome, vulvodynia, endometriosis, adhesive disease, unknown
etiology, etc. At the time of enrollment, participants will be randomized into one of two
groups: either standard pelvic floor physical therapy with weekly saline placebo injections
or standard pelvic floor physical therapy and weekly pudendal blocks for 6 weeks. Standard
physical therapy techniques will be utilized in both groups. Weekly injections of a mixture
of a steroid and local anesthetic or saline will be administered depending on the
randomization. Injections will be administered by a urogynecology physician. The participant
and the treating physical therapist will be blinded to treatment assignment. The participant
will be evaluated with for pelvic floor muscle strength and tenderness and will have pain
assessed by a visual analog scale at baseline, weekly throughout the study, and at 6 months
after study enrollment. Vaginal electromyography will be performed and standardized
questionnaires regarding pelvic floor symptoms, quality of life and sexual function will be
administered at baseline, after 6 weeks of injections and at 6 months after enrollment.
therapy practice with the underlying diagnosis of pelvic floor tension myalgia. This
diagnosis may be secondary to various underlying etiologies including interstitial
cystitis/painful bladder syndrome, vulvodynia, endometriosis, adhesive disease, unknown
etiology, etc. At the time of enrollment, participants will be randomized into one of two
groups: either standard pelvic floor physical therapy with weekly saline placebo injections
or standard pelvic floor physical therapy and weekly pudendal blocks for 6 weeks. Standard
physical therapy techniques will be utilized in both groups. Weekly injections of a mixture
of a steroid and local anesthetic or saline will be administered depending on the
randomization. Injections will be administered by a urogynecology physician. The participant
and the treating physical therapist will be blinded to treatment assignment. The participant
will be evaluated with for pelvic floor muscle strength and tenderness and will have pain
assessed by a visual analog scale at baseline, weekly throughout the study, and at 6 months
after study enrollment. Vaginal electromyography will be performed and standardized
questionnaires regarding pelvic floor symptoms, quality of life and sexual function will be
administered at baseline, after 6 weeks of injections and at 6 months after enrollment.
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.
We found this trial at
1
site
Orange, California 92868
Principal Investigator: Felicia Lane, MD
Phone: 714-456-5475
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