Clinical trial NCT00928564: Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia
Official title: Addition of Pudendal Blocks to Pelvic Floor Physical Therapy for the Treatment of Pelvic Floor Tension Myalgia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Floor Muscle Spasm
Keywords: Pelvic floor muscle spasm
Pelvic pain
physical therapy
pudendal block
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2009-06-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

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.

Primary outcomes:
measure: Visual Analog Pain Score After 6 Weekly Injections
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Improvement in Pelvic Floor Symptoms as Assessed Through Validated Questionnaires
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: UCI Women's Healthcare
state: California
Study officials:
affiliation: University of California, Irvine
name: Felicia Lane, MD
role: PRINCIPAL_INVESTIGATOR
References: